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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 2, 2011

February 2, 2011                                                                                        11-05

 

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS III
___________________________________
PRODUCT
Family Dollar Crisp Apple Bath Sets, Shower Gel/Body Lotion, Net Wt. 3.39 fl. oz., SKU#: 2076014. The sets consist of two 3.39 fl oz plastic bottles, one container of Crisp Apple shower get and one container of body lotion. Recall # F-0366-2011
CODE
Lot numbers: YCY-A08-2010710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Family Dollar Services Inc, Charlotte, NC, by e-mail on October 29, 2010.
Manufacturer: Aidi Cosmetics Co. Ltd., Tai Zhou City, China. Firm initiated recall is ongoing.
REASON
The product contains an unapproved color additive, Naphthol Blue Black.
VOLUME OF PRODUCT IN COMMERCE
174,904 sets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
KeraCare Intensive Restorative Masque; a deep conditioning rinse-out cream hair conditioner packaged in 8 oz. jars (12 jars per case) and 32 oz. jars (6 jars per case); 8 oz jar - UPC 7 96708 33027 2, item AVLON-279 539J3; 32 oz. jar - UPC 7 96708 35014 0, item AVLON-315 53305 (jar alone) and AVLON-316 53315 (with pump). Recall # F-0370-2011
CODE
Batch numbers 09E1903, 09G0801, 09J1001 and 10A1102
RECALLING FIRM/MANUFACTURER
Avlon Industries, Inc., Melrose Park, IL, by e-mails on February 10, 2010 and April 1, 2010. Firm initiated recall is complete.
REASON
The product preservative was insufficient to prevent mold growth in the hair conditioner.
VOLUME OF PRODUCT IN COMMERCE
6,576 - 32 oz. and 17,204 - 8 oz. jars
DISTRIBUTION
Nationwide, including Puerto Rico and the U.S. Virgin Islands, and internationally to Aruba, Dominican Republic, Guadeloupe, Suriname, Trinidad, Ghana, Kenya, South Africa, Nigeria, Sierra Leone, Jamaica, Cayman Islands, Bermuda, Barbados, and the Bahamas

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Brinkman's Gourmet Barbecue Sauce in 22 ounce glass jars, 40 ounce glass jars and 160 ounce plastic jugs UPC: 033244000215, 40 ounce glass jars, UPC: 033244000222, and 160 ounce plastic jugs, UPC: 033244000208. Recall # F-0364-2011
CODE
All product that was distributed up to December 10, 2010.
RECALLING FIRM/MANUFACTURER
Brinkman Farms, Findlay, OH, by press release, letters and telephone on December 13, 2010. FDA initiated recall is ongoing.
REASON
During a routine inspection, an FDA investigator discovered that the allergens, milk and soy were not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
4959 (22 oz jars), 3627 (40 oz jars), 627 (160 oz jugs)
DISTRIBUTION
OH, MI, WI, IL, IA
___________________________________
PRODUCT
Simplot, UpSides, savory side dishes, Orzo Toscano, Net Wt 40 oz (2.5 lb) 1.13 Kg, Keep Frozen, Ingredients: Orzo (water, semolina wheat flour enriched with iron, niacin, thiamine, mononitrate, riboflavin, folic acid), artichoke hearts (artichoke hearts, citric acid, ascorbic acid), mushrooms, onions, wild rice, carrots, sun-dried tomatoes (tomato salt), seasonings (salt, dehydrated onions, sugar, natural flavors, dehydrated mushroom, autolyzed yeast, extract, dehydrated garlic, chicken fat, soybean oil, spices, disodium inosinate and disodium guanylate, maltodextrin, beef extract, partially hydrogenated soybean oil, citric acid), soybean oil, P-01139-00-D. Recall # F-0365-2011
CODE
Units: 987SEP301001 987OCT071001 987OCT081001 987NOV241001 987NOV291001
RECALLING FIRM/MANUFACTURER
Y Not Foods Inc., Madison, WI,  by telephone and e-mail on November 24, 2010, and by telephone on December 16, 2010. Firm initiated recall is ongoing.
REASON
Product may contain undeclared milk and soybean.
VOLUME OF PRODUCT IN COMMERCE
5359 cases (6 - 2.5 lb containers/case)
DISTRIBUTION
AR, IL, KS, OH, OK, TX and Mexico
___________________________________
PRODUCT
Chile Guajillo (Product of Peru). Item # 01-107P, 25 lb Carton, White Box w/BLUE Markings Recall # F-0367-2011
CODE
All product between July 01, 2010 and Nov. 30, 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: El Chilerito Spice Co., South El Monte, CA, by letter on December 10, 2010.
Manufacturer: Alagrocomet Eirl, Lima, Peru. Firm initiated recall is ongoing.
REASON
The recall was initiated because the affected Chile Guajillo product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,508 units
DISTRIBUTION
CA, CO

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Ginger Candy - sold in an 8" x 6" plastic bag containing six individually wrapped pieces of candy. There is a bright orange border at the top of the package. Chinese characters and Ginger Candy appear in the border. The bag is decorated with boxes that alternate between clear and white with blue dots. The bottom of the package shows a large yellow ginger root with green sprouts. There is a character of a winking, black-haired boy on the right-hand side of the package. The word "DaiJyoBu" appears at the boy's feet. Recall # F-0368-2011
CODE
None available
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anhing Corp., Los Angeles, CA, by telephone, email, fax, and visit beginning September 14, 2010.
Manufacturer: JieDong YuZhou Foods Co., Ltd., JieYang, China. California initiated recall is ongoing.
REASON
Ginger Candy tested positive for excessive lead levels.
VOLUME OF PRODUCT IN COMMERCE
255 cases (60 packs./case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Courtier's Pepin Heights 100% Fresh Pressed Apple Cider Flash Pasteurized, Keep refrigerated, 128 Fl oz (Gallon) 3.78L or 64 Fl oz (2 qt) 1.89 L. Recall # F-0369-2011
CODE
USE BY JAN 27 11, USE BY JAN 30 11, USE BY JAN 31 11, USE BY FEB 1 11, USE BY FEB 5 11, USE BY FEB 6 11
RECALLING FIRM/MANUFACTURER
Pepin Heights Orchard, Inc., Lake City, MN, by press release on December 30, 2010 and telephone on January 3, 2011. Firm initiated recall is ongoing.
REASON
The Minnesota Dept. of Agriculture found Higher than allowable levels of patulin present in the product.
VOLUME OF PRODUCT IN COMMERCE
40,398 units
DISTRIBUTION
MN, WI, IA, AZ, TX, FL
___________________________________
PRODUCT
Front of Bag: Colombina mega POPS WATERMELON, CHERRY, ORANGE, GRAPE Artificially Fruit Flavored Candy Pops. Back of Bag: INGREDIENTS: Sugar, Corn Syrup, Citric Acid, Artificial Flavors, Artificial...FD&C Red #40, Yellow #5 and #6, Blue ... . MANUFACTURED IN A FACILITY THAT PROCESSES PEANUTS, EGG ALBUMIN, TREE NUTS, SOY, MILK, WHEAT FLOUR. Not labeled for individual sales. Keep in a dry and cool place. 14 oz bag: sku # 10862, UPC Code 0 14272 10862 3. 28 oz bag: sku # 10873, UPC 0 14272 10873 9 Lot #'s: 2 year shelf life 1209796 Exp April 27, 2012, Qty Manuf 2,056 cases, 1209708 Exp April 24-26, 2012, Qty Manuf 2,000 cases, 1240695 Exp August 13-17, 2012, Qty Manuf 3,296 cases. Recall # F-0371-2011
CODE
Lots: 1209796, 1209708, and 1240695
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colombina Candy Co., Miami, FL, by press release on October 22, 2010.
Manufacturer: Colombina Sa, Cali, Colombia. Firm initiated recall is ongoing.
REASON
Product tested positive for filth - metal fibers and flakes.
VOLUME OF PRODUCT IN COMMERCE
7,352 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
Novedex XT Dietary Supplement Capsules, 60 mg proprietary blend, Testosterone Booster, Anti-Aromatase, 60 count bottles, UPC 6 46511 00655 3. Recall # D-212-2011
CODE
All Lots were distributed between 1/22/2005 and 10/4/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gaspari Nutrition, Lakewood, NJ, by press release on October 7, 2010, and letters on October 18 and 19th, 2010. 
Manufacturer: Bronson Nutritionals, LLC, Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA; product contains 3,17-keto-etiochol-triene as an ingredient on the label, which is a synonym for the same ingredient, commonly known as ATD. ATD is an aromatase inhibitor which is not a dietary ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,399,535 bottles
DISTRIBUTION
Nationwide and China, Indonesia, Dubai, Sweden, United Kingdom, Chile, Kuwait, Hungary, Slovenia, Malta, Mexico, Spain, France, Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
1) Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125mg*, 30 Tablets Rx Only. UPC 3 60505 25393 7 --- NDC 60505-2539-3. Recall # D-201-2011;

2) Amoxicillin and Clavulanate Potassium Tablets, 500 mg/125mg*, 20 Tablets Rx Only. UPC 3 60505 25402 6 --- NDC 60505-2540-2. Recall # D-202-2011;

3) Amoxicillin and Clavulanate Potassium Tablets, 875 mg/125mg*, 20 Tablets, Rx Only. UPC 3 60505 25412 5 --- NDC 60505-2541-2. Recall # D-203-2011
CODE
1) Unit: JG5743;
2) Unit: JG1533;
3) Units: JF0481 and JF0482
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL, by letter dated November 10, 2010. 
Manufacturer: Apotex Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.
REASON
Subpotent; Clavulanate Potassium (15 months stability).
VOLUME OF PRODUCT IN COMMERCE
45,016 units still within expiry
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Triamterene and Hydrochlorothiazide Capsules, USP, 50 mg / 25 mg, 100 Capsules, Rx only, NDC 0781-2715-01. Recall # D-204-2011
CODE
Lot #: 172570, Exp 12/10; 176302, Exp 05/11; 178590, Exp 06/11; 179318, Exp 08/11; 180013, Exp 10/11; 181796, Exp 12/11; 183307, Exp 02/12; 184758, Exp 04/12; 187339, Exp 06/12; 188628, Exp 08/12; 190119, Exp 10/12; 191984, Exp 02/13; 194254, 196706, 197756, Exp03/13; 198604, Exp 07/13
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 19, 2011. Firm initiated recall is ongoing.
REASON
CGMP Deviations; Firm reported use of a blender with a slightly different inside geometry than the blender used during process validation. Using a blender that has not been validated indicates CGMP deviations.
VOLUME OF PRODUCT IN COMMERCE
515,466 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) SULAR (nisoldipine) Extended Release 25.5 mg tablets, Rx only, 100 Tablets, NDC 59630-502-10. Recall # D-210-2011;

2) SULAR (nisoldipine) Extended Release 17 mg tablets, Rx only, 100 Tablets, NDC 59630-501-10. Recall # D-211-2011
CODE
1) Lot # 2020210;
2) Lot # 2020569
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shionogi Pharma, Inc., Atlanta, GA, by letter on December 23, 2010.
Manufacturer: Skye Pharma Production SAS, St Quentin Fallavier Cedex, France;
Manufacturer: Catalent Pharma Solutions, Corby, Northants, United Kingdom. Firm initiated recall is ongoing.
REASON
The product failed dissolution testing at 4 hours at the 12 month stability testing time point.
VOLUME OF PRODUCT IN COMMERCE
24,362 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) 12% LAC Lotion (Ammonium Lactate) Lotion RX Only, Contains: *Ammonium lactate equivalent to 12% lactic acid, light, For dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use. Net Wt 400 g, NDC 0574-2021-16 UPC barcode 05742 02116. Recall # D-205-2011;

2) 12% LAC Lotion (Ammonium Lactate) Lotion RX Only, * CONTAINS: *Ammonium lactate equivalent to 12% lactic acid, For dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use. Net Wt. 225 g, NDC 0574-2021-08, UPC barcode 05742 02108. Recall # D-206-2011
CODE
1) Lot #: 2009146477 2009146478 2009146479 2009186809 2009186811;
2) Lot #: 2009146480 2009146481
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letter dated December 15, 2010 and December 20, 2010. Firm initiated recall is ongoing. 
REASON
Failed Impurity Specification; 18 month stability time point for Impurity B and Total Impurities.
VOLUME OF PRODUCT IN COMMERCE
69,239 units
DISTRIBUTION
Nationwide and Italy
___________________________________
PRODUCT
1) Tylenol Cold Multi Symptom Daytime Liquid, (acetaminophen 325mg, dextromethorphan HBr 10mg and phenylephrine 5mg), 8 oz bottles, Citrus Burst flavor. UPC 300450527086. Recall # D-207-2011;

2) Tylenol Cold Multi Symptom Nighttime Liquid, (acetaminophen 325mg, dextromethorphan HBr 10mg, doxylamine succinate 6.25mg and phenylephrine 5mg), 8 oz bottles, Cool Burst flavor, UPC 3004505269089. Recall # D-208-2011;

3) Tylenol Cold Multi Symptom Severe Day Liquid (acetaminophen 325mg, dextromethorphan HBr 10mg, guaifenesin 200mg and phenylephrine 5mg), 8 oz Cool Burst, UPC 300450521088. Recalling # D-209-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letters on November 23, 2010.
Manufacturer: DPT Lakewood, Inc., Lakewood, NJ. Firm initiated recall is ongoing. 
REASON
Misbranded: alcohol content not listed on front panel.
VOLUME OF PRODUCT IN COMMERCE
7,290,108 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0118-11;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0119-11
CODE
1) and 2) Unit: B368517
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Puget Sound Blood Center, Seattle WA, by facsimile on November 21, 2006.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0514-11;
2) Plasma Cryoprecipitated Reduced. Recall # B-0515-11;
3) Red Blood Cells. Recall # B-0516-11;
4) Fresh Frozen Plasma. Recall # B-0517-11
CODE
1) Units: 12F31882, 012G84201, 12Q735530;
2) and 4) Unit: 12F13761;
3) Units: 12F25244; 12F13761; 12F31882; 12FS73212; 12G84201; 12G24201; 12C61256; 12F10521, 12Q73530, 12R04807, 12Y32517;
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on December 1, 2006 and by letter on December 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0518-11
CODE
Units: 5280032243; 5280031852; 5280030293; 5280027799; 5280027421; 5280018809
RECALLING FIRM/MANUFACTURER
IBR PlasmaCenters, LLC, Lubbock, TX, by e-mail on October 6, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0520-11
CODE
Units: 4200060735; 4200060117; 4200060016; 4200059550; 4200058975; 4200058450
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Charlotte, NC, by facsimile on September 21, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0521-11
CODE
Unit: 72P727041
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on September 29, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Plasma Frozen. Recall # B-0522-11
CODE
Unit: W071210061356
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter and telephone on September 8, 2010. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0524-11
CODE
Unit: W067110041759
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on September 7, 2010 and letter, October 7, 2010. Firm initiated recall is complete.
REASON
Blood product, which was labeled incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0525-11;
2) Plasma Frozen. Recall # B-0526-11
CODE
1) and 2) Unit: 011FR26141
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile and telephone on August 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0637-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0639-11
CODE
Unit: W149510208367
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by facsimile on October 26, 2010 and e-mail on October 28, 2010. Firm  initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0640-11
CODE
Unit: 06LR60367
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile and Observation Report on August 30, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0642-11; 
2) Platelets. Recall # B-0643-11;
CODE
1), 2) Unit: W035210144007R
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on October 14, 2010, by letter on November 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX, NJ
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0646-11;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0647-11;
3) Fresh Frozen Plasma. Recall # B-0648-11
CODE
1) Unit: W127810504053;
2) and 3) Unit: W127809601154
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter and telephone on September 23, 2010 and by letter November 4, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0680-11
CODE
Unit: W072110002007
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group, San Diego, CA, by facsimile, letter and telephone on August 16, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0681-11
CODE
Unit: 198206065
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone and facsimile on February 15, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0682-11
CODE
Unit: 7341757
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc-cellular Therapy Laboratory, New York, NY, by facsimile on August 3, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete
REASON
Blood product, which was possibly contaminated with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0683-11
CODE
Units: 192659893 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on October 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as negative for the little c red cell antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0700-11
CODE
Units: 7020732 (BAG1); 7020732 (BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on June 1, 2007 and fax on June 4, 2007. 
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Bacillus species and Enterococcus casseliflavus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
split unit (2)
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0701-11
CODE
Unit: 7029424
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on June 19, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
NY

___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0703-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0704-11
CODE
1) and 2) Unit: 8215641
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on December 6, 2004.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-0705-11
CODE
Units: 0888606; 088606; 0889811; 0889842; 0889842; 0889842; 0889838
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on December 10, 2004. 
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, with insufficient plasma to support the platelet concentrations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-0706-11
CODE
Unit: 60948511
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on December 27, 2004. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-0707-11
CODE
Unit: 0891610
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on January 21, 2005.   
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0708-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0709-11
CODE
1) and 2) Unit: 0892123
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on April 4, 2005.  
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0711-11;
2)Recovered Plasma. Recall # B-0712-11
CODE
1) and 2) Units: 197528420
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter dated July 29, 2005 and by Electronic Delivery Note on June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred following exposure to hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, NV
___________________________________
PRODUCT
Source Plasma. Recall # B-0716-11
CODE
Units: 10GMIB4710; 10GMID6866; 10GMID5007; 10GMID4612; 10GMID2983; 10GMID2589; 10GMID0611; 10GMIC1785; 10GMIC0631; 10GMIB9820; 10GMIB8712; 10GMIB5868
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, Walker, MI, by e-mail and facsimile on September 21, 2010. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. B-0720-11
CODE
Unit: W091010248021 and W091010123783
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on September 10, 2010 and facsimile on September 27, 2010. Firm initiated recall is complete.
REASON
Blood products collected from therapeutic donor diagnosed with Polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, CA, OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0724-11
CODE
Unit: 224700864 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on January 2, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
1) Fresh Frozen Plasma, Recall # B-0725-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0726-11
CODE
1) and 2) Unit: 192664709
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone and facsimile on February 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0727-11
CODE
Unit: 7318723
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc-cellular Therapy Laboratory, New York, NY, by telephone on August 21, 2007 and by letter dated August 23, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0729-11
CODE
Units: W090710005129; W090710001697; W090710027529; W090710023493
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by fax on October 28, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0113-11
CODE
Unit: W067110705555
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 30, 2010 and letter September 20, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Source Plasma. Recall # B-0519-11
CODE
Units: 365033655; 365038901; 365002735; I68071011; 365028368; 365009664; 365007664; 365006827; 365005833; 365035766; 365027960; 365037675; 365026440; 365034044; 365033008; I68073565; 365033048; 365035060, 365037675, 365026440, 365034044, 365033008, I68073565, 365033048, 365035060, 365033655, 365038901, 365002735, I68071011, 365028368, 365009664, 365007664, 365006827, 365005833, 365035766, 365027960, 365009444, 365006326, 365005750, 365035282, 365026239, 365026148, 365006748, I68071098, I68069425, 365035930, 365007666, 365002051, I68073446, I68055659, 365037305, 365037089, 365036172, 365002622, 365002139, I68073663, I68072288, I68071782, I68070762, I68068778, I68064570, 365032642, 365036274, 365028999, 365026953, 365037095, 365035932, 365035116, 365033788, 365032375, 365004343, I68070611, I68069476, 365033687, 365032289, 365026229, 365029088, 365027467, 365008511, 365005673, 365001770, 365000605, I68073544, I68073295, I68069129, I68066380, I68065860, 365033036, 365025246, 365032913, 365031763, 365026843, 365033730, 365004811, I68070356, I68069784, 365033633, 365024278, 365035904, 365000223, 365036160, 365032207, 365025864, 365013238, 365035806, 365033901,365032948, 365030450, 365033874, 365031914, 365005736, 365003802, 365001953, 365037712,365035827, 365032694, 365040609, 365037284, 365035145, 365033546, 365035707, 365035318, 365027530, 365008958, 365005755, I68072433, I68071246, I68063152, 365037410, 365040842,365033732, 365030716, 365032910, 365030567, 365037691, 365033742, 365030580, 365030266, 365007974, 365006968, 365004515, 365000910, I68071198, 365035144, 365033685, 365030843,365023340, 365023050, 365000535, 365035698, 365031811, 355029278, 365027681, 365004282, 365026427, 365032898, 365030837, 365028017, 365027063, 365025631, 365037087, 365036443, 365036900, 365031757, 365030415, 365029120, 365034430, 365032929, 365032465, 365032591, 365030123, 365029335, 365028855, 365028378, 365024272, 365000252, 365040781, 365038109, 365037335, 365035910, 365031762, 365030159, 365027180, 365026727, 365024689, 365008155, 365002741, 365001761, I68073202, I68066412, I68065468, I68064349, 365034703, 365032895, 365028108, I68070619, I68066674, I68066032, 365038128, 365030919, 365008777, 365003460, 365002107, 365001261, 365000634, I68073908, I68064596, 365032645, 365032873, 365032641,365004287, 365030154, 365034325, 365036319, 365023368, 365011493, 365004204, 365037998,365035785, 365043383, 365034185, 365032520, 365027754, 365008107, 365006841, 365004131, 365003914, 365002554, I68072508, I68070338, I68069138, I68068859, I68064459, I68063672,365041231, 365034589, 365035367, 365036433, 365034399, 365037015, 365036179, 365030748, 365002006, 365000888, I68073237, I68071149, I68070806, I68069818, I68067776, I68065751, I68064566, 365033935, 65033352, 365032175, 365007334, I68062990, 365035381, 365035169, 365034268, 365026336, 365026153, 365034010, 365033982, 365031830, 365030880, 365027929,365025651, 365009328, 365006972, 365005959, 365036196, 365028769, 365009343, 365009053, 365008456, 365005390, 365035940, 365036469, 365026391, 365026340, 365038248, 365035149, 365033889, 365033635, 365024692, 365005711, 365004340, 365040604, 365032870, 365032603, 365035254, 365034446, 365031928, 365030795, 365029309, 365027489, 365014058, I68072324,365041501, 365038919, 365003113, 365001238, I68073730, I68073284, I68069996, 365037624,365009085, I68054704, 365036354, 365033670, 365036841, 365026164, 365037249, 365036245,365035136, 365033810, 365032382, 365026950, 365025313, 365007623, 365005707, 365003777,I68055642, 365036212, 365035837, 365032368, 365028886, 365013038, 365005884, 365002449,365002118, I68074051, I68073543, I68070801, I68066253, I68064833, 365041285, 365038903, 365037172, 365035831, 365030792, 365030454, 365029100, 365025855, 365006209, 365004627,365003962, 365003105, 365001448, 365000944, I68074334, I68073853, I68071774, I68066658, I68066120, I68064580, I68062943, 365014760, 365041440, 365031750, 365004664, 365003761, I68074402, I68074094, I68071780, I68064202, 365033150, 365030787, 365032639, 365033310,365030669, 365028974, 365028008, 365004115, 365000683, I68074349, I68073397, I68072424, I68066566, I68066086, 365040773, 365033976, 365028444, 365008659, 365008171, 356006182, 365001401, I68071910, 365038168, 365036352, 365026170, 365033985, 365031477, 365029185,365026922, 365010301, 365009361, 365008740, 365006269, 365005964, 365004999, 365004338,365003115, 365001172, 365000586, I68073599, I68072704, I68070703, 365038914, 365036885, 365026786, I68071093, 365041220, 365041164, 365028933, 365027739, 365026792, 365038084,365036361, 365031777, 365029048, 365025784, 365009709, 365009066, 365005846, 365004863, 365004548, 365002598, I68073622, I68073322, I68070558, I68068870, I68068561, I68064376, 365041354, 365038006, 365035058, 365029107, 365027208, 365025258, 365013089, 365005590,365004717, 365003723, 365003144, 365001934, I68073584, I68072660, I68070369, I68066430, I68065476, I68064952, I68063834, 365038061, 365032518, 365030696, 365029181, 365037352, 365035218, 365000301, 365032575, I68071385, 365041515, 365037939, 365036372, 365035311,365034279, 365030142, 365027058, 365023872, 365033590, 365032485, 365031893, 365010410, 365005394, 365006327, 365004435, 365036315, 365036870, 365004763, 365004168, I68073264, I68072974, 365041357, 365038571, 365037752, 365037242, 365036383, 365032542, 365030497,365026571, 365013275, 365009725, 365008773, I68064194, 365006853, 365003771, 365003463, 365002017, I68071106, I68070866, I68069789, I68044487, 365004394, 365027509, 365022302,365007571, 365006771, 365025688, 365007939, 365007700, I68074073, 365010457, 365009403, 365007551, 365006530, 365004070, 365002266, 365001794, 365001285, I68073990, 365029348,365026059, I68074062, I68055763, I68073351, I68069486, I68069450, 365004319, I68055793,365027796, 365014054, 365004363, 365001783, 365000961, I68073935, I68073640, I68070732, I68068947, I68067606, 365016865, 365001209, I68074009, I68070335, I68069980, 365026952, 365024679, 365002761, 365000847, 365005470, 365000565, I68068887, I68066701, 365009500,365026881, 365028088, 365025698, 365009517, 365008453, 365007910, 365006167, 365003958, 365002357, 365001685, I68066821, I68065742, 365026154, 365030799, 365030432, 365007993, I68084581, 365007653, 365028752, 365009482, 365007694, I68072578, 365006324, 365004140,365003698, 365001217, 365010479, I68071201, 365006469, 365003874, I68072041, I68070782, 365004546, I68055782, 365005887, I68071864, I68071329, I68066809, 365027116, 365025600,365024431, 365023903, 365007598, 365004111, 365002759, 365002287, I68072956, I68071949, 365013267, 365002328, I68074302, I68072572, I68071433, I68070468, I68067627, I68066793,I68064857, I68062715, 365028024, I68072631, 365029355, 365024419, I68072688, I68072688, I68070193, I68064107, I68063185, 365010307, 365000926, 365030739, 365010374, 365002104,I68074355, I68072698, 365032527, 365027798, 365016148, 365004355, 365002534, 365002396,I68070978, I68070710, 365030200, I68070264, 365025248, 365005942, 365030148, 365026800,365000418, 365006886, 365002608, 365002004, I68072938, 365007782, 365005728, 365029368,I68044484, 365008761, I68044373, 365006177, 365006458, I68055696, I68061947, 365007281, 365025627, 365000142, I68074040, I68064462, 365009996, 365042296, 365041890, 365041486,365041122, 365040764, 365040371, 365039937, 365039085, 365038674, 365038247, 365037871,365037386, 365037102, 365036550, 365036228, 365035761, 365035525, 365034418, 365034169,365033628, 365033446, 365032390, 365031778, 365031507, 365030644, 365030210, 365029763,365029377, 365028960, 365028488, 365025776, 365025377, 365024841, 365024562, 365023864,365023714, 365022918, 365022771, 365022135, 365016175, 365015589, 365016926, 365014646,365014437, 365013749, 365015482, 365013062, 365012854, 365011954, 365011350, 365011025,365010344, 365010066, 365009284, 365009024, 365008463, 365007998, 365006914, 365006540,365006023, 365005525, 365004716, 365002494, 365002404, 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365028431, 365000923, I68073940, I68072589, I68069066, I68066594, I68064480, 365028376,365027717, 365001318, I68072522, I68071242, I68071039, I68068829, 365028418, 365022719,365001198, I68064374, 365009334, 365002629, I68055677, I68063301, 365025570, 365010726, 365009662, 365001956, I68071771, I68070063, I68068757, I68068522, I68066751, I68066403, I68062859, 365011451, 365008631, 365002351, 365001857, 365000922, I68068977, I68064663, I68062732, 365025323, 365002211, 365000514, I68072725, 365006940, 365004970, 365004490, 365004003, 365004085, 365001356, I68074240, I68071134, 365023766, 365016862, 365008597,365006253, 365005616, 365004574, 365004360, I68064839, I68063561, I68063208, 365000212, 365002728, I68066768, 365030281, 365004898, 365004029, 365002657, I68073141, I68064131, I68063903, I68062940, 365027576, 365000876, I68072925, I68070921, I68070027, I68066607, I68064657, I68062670, 365016860, 365025761, 365023110, 365010371, 365002084, 365006282, 365000225, 365009614, 365008517, 365007788, 365026954, 365004915, 365008014, 365006860,365004336, 365003297, I68055856, 365004813, 365002285, 365001303, I68071217, I68067763,I68066653, I68066363, I68070179, 365006279, 365001706, I68070472, I68063261, I68070208, I68069193, I68069635, I68065840, I68065462, I68064944, I68062813, 365006153, 365027789, 365025936, 365013141, 365008783, I68070484, 365007657, I68072935, 365009033, 365008413,365007822, 365006291, 365005652, 365007873, 365000870, I68072726, 365004738, I68073024,365009465, 365008524, 365027607, 365008711, 365006751, 365006330, 365004304, 365002803, 365002499, I68064355, 365008713, 365004891, 355001839, I68072450, 365003873, 365002216,365000755, I68074044, I68055729, 365000185, 365027801, 365027457, I68066686, 365009273,365000271, 365000816, I68071988, I68069085, I68067771, I68066664, I68063794, 365010341,365009369, 365009017, 365008144, 365004875, 365004093, 365003870, 365008905, 365007728,365006853, 365005727, 365004733, 365004025, 365002834, I68073486, I68063552, 365006066,365005773, 365004771, 365003742, I68070497, I68055613, I68064399, I68063873, 365007286, I68070605, I68055811, I68063967, 365005767, 365004325, I68070980, I68071913, I68071215, I68069915, I68066591, I68064939, 365000947, 365009607, 365003812, 365002635, I68069797,365010819, 365006836, 365005813, 365003831, 365002673, 365001862, 365000818, I68073008, I68072280, I68071041, I68084265, I68063666, 365004526, 365004044, 365003108, 365002717,365000916, I68073882, I68069126, 365010516, I68066425, I68064706, 365002159, 365000950,365006965, 365006300, 365004779, 365003836, 365004353, 365000141, 365008619, 365006473, 365004819, 365003940, 365003750, I68073190, I68070046, I68055789, I68064281, 365005476, I68073320, I68071459, I68070522, I68065205, 365027709, 365002203, I68063714, 365002698,I68073746, I68073151, I68069496, I68062621, 365023796, 365008636, 365002516, I68069157,365005503, 365005032, I68055591, 365003273, 365000352, 365014016, 365030439, 365023181,365008704, 365000336, 365002620, 365001641, 365000800, I68055772, 365009601, 365008684,365004271, 365001962, 365001643, 365010272, 365009305, I68063622, I68044467, 365030243,365028857, 365027539, 365026607, 365008651, 365007761, 365006892, 365000886, 365000524,I68073526, I68072534, I68068984, I68067672, I68064177, 365007962, I68071052, I68070706, I68067781, I68064276, I68063831, I68063256, I68066551, I68065209, I68064278, 365013136,I68064960, 365013764, 365004246, 365003282, 365001877, 365000714, I68070530, I68067638, I68070098, 365002807, 365001342, I68073342, I68073057, I68071975, I68070479, I68069047, I68069718, I68066395, I68065359, I68064702, 365029028, 365009031, 365000893, I68070779, I68063822, I68065686, I68055674, I68066544, 365002723, 365001717, 365000458, I68073122, I68072694, 365028851, 365032490, 365027597, 365026612, 365025719, 365029024, I68072402, I68073253, 365009575, I68071829, I68071108, I68070344, I68074107, 365004479, 365003834, 365002702, I68071087, I68070113, I68066817, 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I68065217, I68063788, I68071920, I68066191, I68065249, I68064421, I68071312, I68071048, I68062624, I68066193, I68065282, I68062573, I68065471, I68055756, 365009310, 365004619, 365004099, 365002637, I68071322, I68065354, I68062863, 365034968, I68055813, 365005524, I68068807, 365000011, 365028878, 365032359, I68066187, I68063160, I68062719, I68070288, I68062816, 365006546, 365000246, 365016867, 365007163, 365034878, 365033571, 365033292, 365032386, 365030765, 365028822, 365006017, 365005565, 365004392, 365003938, 365002082, I68074243, I68073420, I68073082, I68072393, I68071155, I68067779, 365035616, 365026457, 365007413, 365007388, I68069991, I68067812, 365037012, 365036481, 365036161, 365031456, 365028415, 365006805, 365006289, 365005757, 365004773, 365001975, I68073166, I68071440, I68055653, I68069478, I68066836, I68066535, I68065761, I68064124, I68062775, 365007337, 365034555, 365034570, 365034736, 365034728, I68074048, I68073105, 365000690, I68070910, I68069764, I68065441, 365022296, 365003781, 365001941, I68073953, I68071942, I68068738, I68066619, I68064757, 365026869, 365000129, I68055588, I68069685, I68069097, 365013173, 365007671, 365006045, 365004301, 365002493, I68062779, I68064713, 365005428, 365000104, 365010529, I68070050, I68068557, I68066061, 365028055, 365027750, 365027147, 365025713, 365008638, 365006318, I68070412, I68066523, I68064553, I68063618, 365013272, 365007009, I68063915, I68063176, 365004018, 365000010, 365011170, 365010655, 365010175, 365009628, 365008738, 365008189, 365006572, 365006076, 365005600, 365004417, I68073638, I68065427, 365000530, 365005035, 365007542, 365000267, I68064886, 365008586, 365004987, 365002688, I68066643, I68065995, 365028891, 365027911, 365016870, I68073271, I68063151, I68044338, 365001802, 365000595, I68073087, I68071788, I68071082, I68070786, I68070139, I68055502, 365027425, 365010807, 365006335, 365005496, 365000148, 365041068, 365039870, 365039071, 365035111, 365033773, 365033372, 365032078, 365028591, 365028128, 365027340, 365025598, 365025124, 365024592, 365024129, 365016772, 365010165, 365005283, I68055672, 365010338, I68068837, I68063062, 365033720, 365029072, 365027571, 365005594, I68070371, 365033568, 365028948, 365028664, 365027989, 365002601, 365002113, 365001608, I68073647, I68071940, I68071389, I68065682, I68064165, I68063840, 365010272, 365000415, 365000355, 365000391, 365013096, 365010369, I68055567, 365000290, 365000181, 365000430, 365026248, 365026269, 365026443, 365026493, I68055673, I68044402, I68055571, 365000354, 365000128, 365000139, 365000387, I68055663, I68044367, I68055737, I68055760, I68055788, 365000169, I68055641, 365000165, I68044374, 365026268, I68055768, 365007062, I68055586, 365026451, I68055780
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Roanoke, VA, by fax on October 25, 2006. Firm initiated recall is complete.  
REASON
Blood products collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,048 units
DISTRIBUTION
NC, MA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0523-11
CODE
Unit: W040710613690
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on August 19, 2010 and by letter dated October 6, 2010. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

___________________________________
PRODUCT
Recovered Plasma. Recall # B-0638-11
CODE
Unit: W149510208367
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by facsimile on October 26, 2010 and e-mail on October 28, 2010. Firm  initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0641-11
CODE
Unit: 06LR60367
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile and Observation Report on August 30, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
CODE
Unit: W035210144007R
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on October 14, 2010, by letter on November 2, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX, NJ
___________________________________
PRODUCT
1) Source Leukocytes. Recall # B-0644-11;
2) Recovered Plasma. Recall # B-0645-11
CODE
1) and 2) Unit: W035210144007R
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on October 14, 2010, by letter on November 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0685-11
CODE
Units: 192616010, 192616011, 192616012
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Reno, NV, by telephone on August 15, 2005. Firm initiated recall is complete. 
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced.  Recall # B-0710-11
CODE
Unit: 8744556
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0717-11
2) Recovered Plasma. Recall # B-0718-11
CODE
1) and 2) Unit: W036510088905
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Baton Rouge, LA, by e-mail on September 27, 2010 and letter October 12, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0719-11 
CODE
Unit: 017KM97369
RECALLING FIRM/MANUFACTURER
American National Red Cross (The) - North Central Region, Saint Paul, MN, by telephone on August 30, 2010 and by letter dated September 7, 2010. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0728-11
CODE
Unit: 024GK58653
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by electronic mail on October 25, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I
___________________________________
PRODUCT
Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis. Recall # Z-0941-2011
CODE
Lot Number: H179575
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by e-mail, telephone and/or fax, dated December 17, 2010. Firm initiated recall is ongoing.
REASON
Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.
VOLUME OF PRODUCT IN COMMERCE
378 units
DISTRIBUTION
AL, AR, CA, FL, GA, IL, MD, MI, MO, MS, ND, PA, SC, TN, and UT
___________________________________
PRODUCT
Percutaneous Insertion Tray for use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845. Recall # Z-0969-2011
CODE
Lot Numbers: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International, Inc., Division of Teleflex Medical Inc., Everett, MA, by letter on December 21, 2010.  
Manufacturer: Arrow Internacional de Chihuahua S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. 
VOLUME OF PRODUCT IN COMMERCE
33,662 units
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia. Madrid, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Columbia, Ecuador, India, Indonesia, Japan, Korea Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
___________________________________
PRODUCT
1) RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20. The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Recall # Z-0337-2011;

2) RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20. The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Recall # Z-0338-2011;

3) RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40.  The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Recall # Z-0339-2011
CODE
1) Lot Number: 0071361;
2) Lot Number: 0072061;
3) Lot Number: 0070961
RECALLING FIRM/MANUFACTURER
Abbott Vascular, Temecula, CA, by letter dated September 10, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The AT1 Autotransfusion Set is distributed by Fresenius Kabi on its own or as part of a ATF40 kit or ATF120 kit. AT1 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Recall # Z-0340-2011;

2) The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a  inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filters, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 40 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Recall # Z-0341-2011;

3) The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR120 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a 1/4 inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 120 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Recall # Z-0342-2011
CODE
1) Lot numbers: YFT 223, YFT 242, YFT 261, YHT 271, YHT 283, YIT 021, YIT 072, YIT 083, YIT 161, YIT 172, YIT 211, YKT 161, YKT 263, YLT 023, YLT 042, YLT 062, YLT 121, YLT 172, YLT 231, YLT 262, YLT 271, and YMT 011;

2) Lot numbers: YHT242, YIT012, YIT291, YKT011, YKT142, YKT283, YLT302, ZAT262, ZBT125, ZCT 032, and ZCT 295;

3) Lot numbers: YHT 103, YHT 124, YHT 262, YIT 042, YIT 112, YIT 181, YKT 061, YKT 083, YKT 212, YKT 291, YLT 053, YLT 101, YLT 182, YMT 092, YMT 172, ZAT 292, ZBT 192, ZBT 262, ZCT 121, and ZCT 311
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Kabi, LLC, Redmond, WA, by letter dated March 29, 2010.
Manufacturer: Fresenius Hemocare Netherlands B.V, Emmer-Compascuum, Netherlands. Firm initiated recall is ongoing.
REASON
Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode.
VOLUME OF PRODUCT IN COMMERCE
18, 200 units of AT1; 17,444 units of ATF40; 25,740 units of ATF120
DISTRIBUTION
Nationwide, and Australia, Austria, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, Philippines, Portugal, Switzerland, Thailand, UK, and Vietnam
___________________________________
PRODUCT
Power supply boards on Dash 3000, 4000 and 5000 Monitors. Recall # Z-0359-2011
CODE
Serial Number SD010085037GA SD010085039GA SD010085040GA SD010085056GA SD010085038GA SD010085041GA SD010085054GA SD010085055GA SD010085058GA SD010085059GA SD010085060GA SD010085061GA SD010085062GA SD010085064GA SD010095296GA SD010095300GA SD010095301GA SD010095302GA SD010095303GA SD010095304GA SD010095305GA SD010095306GA SD010095307GA SD010095308GA SD010095309GA SD010095310GA SD010085197GA SD010095549GA SD010095550GA SD010095551GA SD010095552GA SD010095553GA SD010095556GA SD010095557GA SD010095558GA SD010095560GA SD010095561GA SD010095562GA SD010095563GA SD010095564GA SD010095565GA SD010095566GA SD010095569GA SD010095570GA SD010095571GA SD010095573GA SD010095574GA SD010095575GA SD010095720GA SD010095481GA SD010095482GA SD010095484GA SD010095487GA SD010095488GA SD010095619GA SD010095620GA SD010095621GA SD010095623GA SD010095399GA SD010095385GA SD010095369GA SD010095373GA SD010095408GA SD010095410GA SD010095411GA SD010095412GA SD010095413GA SD010095267GA SD010095269GA SD010095270GA SD010095271GA SD010095272GA SD010095274GA SD010095275GA SD010095384GA SD010095386GA SD010095387GA SD010095388GA SD010095389GA SD010095390GA SD010095391GA SD010095392GA SD010095393GA SD010095394GA SD010095415GA SD010095416GA SD010095417GA SD010095419GA SD010095455GA SD010095457GA SD010095458GA SD010095463GA SD010095465GA SD010095466GA SD010095468GA SD010095469GA SD010095470GA SD010095471GA SD010095472GA SD010095473GA SD010095475GA SD010095223GA SD010095225GA SD010095227GA SD010095228GA SD010095229GA SD010095230GA SD010095231GA SD010095232GA SD010095233GA SD010095234GA SD010095235GA SD010095236GA SD010095237GA SD010095239GA SD010095240GA SD010095242GA SD010095243GA SD010095244GA SD010095245GA SD010095247GA SD010095248GA SD010095249GA SD010095251GA SD010095252GA SD010095253GA SD010095259GA SD010095260GA SD010095261GA SD010095420GA SD010095421GA SD010095423GA SD010095424GA SD010095427GA SD010095428GA SD010095418GA SD010095480GA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated October 8, 2010.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient solder on the power supply board could result in excess EMC emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in a loss of monitoring that could delay recognition of a clinical event.
VOLUME OF PRODUCT IN COMMERCE
137 units
DISTRIBUTION
IL, NV, TX, and VA, Australia, Brazil, China, Japan, South Korea, and Taiwan
___________________________________
PRODUCT
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Recall # Z-0361-2011
CODE
Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters dated January 21, 2009.
Manufacturer: Ethicon Endo-surgery, Inc. S.a. De C.v., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time, tissue manipulation, and a change in the operative approach.
VOLUME OF PRODUCT IN COMMERCE
4,113 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module. Recall # Z-0363-2011
CODE

Parent SN AAD05390701GA AAD05390702GA AAD05390703GA AAD05390704GA AAD05390705GA AAD05390706GA AAD06031132GA AAD06031137GA AAD06131461GA AAD06131462GA AAD06131466GA AAD06131468GA AAD06131472GA AAD06171539GA AAD06221773GA AAD06221776GA AAD06221777GA AAD06251813GA AAD06251830GA AAD06251851GA AAD06251853GA AAD06251856GA AAD06251857GA AAD06261923GA AAD06261927GA AAD06281937GA AAD06362122GA AAD06372145GA SCS06500630GA SCS06500645GA SCS06500649GA SCS06500661GA SCS06500663GA SCS07010713GA SCS07080892GA SCS07080901GA SCS07201199GP SCS07201200GP SCS07201201GP SCS07201202GP SCS07201203GP SCS07201204GP SCS07201205GP SCS07201206GP SCS07201207GP SCS07281360GP SCS07281361GP SCS07281362GP SCS07281363GP SCS07281364GP SCS07281365GP SCS07281366GP SCS07281367GP SCS07281368GP SCS07281369GP SCS07281370GP SCS07281371GP SCS07281372GP SCS07281373GP SCS07281374GP SCS07391691GA SCS07441939GA SCS08383087GA SCS07482026GA SCS08493368GA SCS08493387GA SCS07221315GA SCS07221316GA SCS07221317GA SCS07221322GA SCS07361513GA SCS07361519GA SCS09464289GA SCS08352985GA SCS08352989GA SCS08362994GA SCS08362997GA SCS08362998GA SCS08363002GA SCS08363009GA SCS08363010GA SCS08363011GA SCS08363012GA SCS08363013GA SCS08363015GA SCS08363017GA SCS08363018GA SCS08363024GA SCS08423226GA SCS08122513GA SCS08142588GA SCS08142590GA SCS08142595GA SCS08142597GA SCS08162602GA SCS08292852GA SCS08292856GA SCS06440374GA AAD06261865GA AAD06261879GA AAD06362136GA AAD06362142GA AAD06372146GA AAD06372160GA AAD06372162GA AAD06372163GA AAD06372165GA SCS07371545GA SCS07371547GA SCS07461979GA SCS08132536GA SCS09173726GA AAD06031155GA AAD05430764GA AAD05430776GA AAD05430777GA SCS08393161GA SCS08413170GA SCS08413173GA SCS07080875GA SCS07080884GA SCS07080907GA SCS07391631GA SCS07391683GA SCS09474313GA SCS09474319GA SCS09474327GA SCS09303900GA SCS08172648GA SCS08192660GA SCS08192662GA SCS08202677GA SCS08202678GA SCS08212695GA SCS08212698GA SCS08212699GA SCS08473302GA SCS08473306GA SCS08473307GA SCS08473308GA SCS08473310GA SCS08473313GA SCS08473321GA SCS08473325GA SCS08473327GA SCS08473331GA SCS09454267GA SCS09474338GA SCS09153713GA SCS09173719GA SCS09333987GA SCS09333988GA SCS09333989GA SCS09333990GA SCS09333991GA SCS09333992GA SCS09333993GA SCS09333995GA SCS09333996GA SCS09333997GA SCS09424201GA SCS09424202GA SCS09263820GA SCS09263821GA SCS09263822GA SCS09263823GA SCS09263824GA SCS09263825GA SCS09263828GA SCS07431852GA AAD05240213GA AAD05310398GA AAD05310399GA AAD05310400GA AAD05310401GA AAD05310402GA AAD05310403GA AAD05310404GA AAD05310405GA AAD05430743GA AAD05430744GA AAD05430797GA AAD05430798GA AAD05521016GA AAD05521017GA AAD06171503GA AAD06171511GA AAD06171512GA AAD06171513GA AAD06171521GA AAD06171522GA AAD06221761GA AAD06221780GA AAD06221783GA AAD06231785GA SCS06390095GA SCS06500654GA SCS06500659GA SCS07482033GA SCS08312920GA SCS08312921GA SCS08312922GA SCS08312938GA SCS08493414GA SCS08513453GA SCS08513454GA SCS09073623GA SCS09183734GA SCS09183736GA SCS09193750GA SCS09193751GA SCS09193756GA SCS09193757GA SCS09193758GA SCS09203759GA SCS09203761GA SCS09203764GA SCS09203765GA SCS09203766GA SCS09203769GA SCS09203770GA SCS09203771GA SCS09203772GA SCS09203774GA SCS09203777GA SCS09203779GA SCS09203780GA SCS09203783GA SCS09203785GA SCS09203788GA SCS09233789GA SCS09233790GA SCS09233792GA SCS09233794GA SCS09233795GA SCS09233796GA SCS09233797GA SCS09233798GA SCS09233802GA SCS09233803GA SCS09233804GA SCS09233805GA SCS09233806GA SCS09243807GA SCS09243815GA SCS09333958GA SCS09333964GA SCS09333967GA SCS09444231GA SCS09444234GA SCS09444238GA SCS09444239GA SCS09444250GA SCS09444251GA SCS09514363GA SCS10174625GA SCS10174629GA SCS08132558GA SCS08132562GA SCS07391644GA SCS07391651GA SCS08082361GA SCS08122493GA SCS08112432GA SCS10074433GA AAD06131475GA AAD06131479GA SCS09233801GA SCS08092379GA SCS08162603GA SCS06420278GA SCS06420279GA SCS06420285GA SCS06420287GA AAD06261897GA SCS07441928GA SCS07441966GA SCS07482061GA SCS07482077GA SCS07482081GA SCS07482082GA SCS07482083GA SCS08252812GA SCS08262839GA SCS09514373GA SCS09514386GA SCS09514395GA SCS07391723GA SCS07391732GA SCS07391733GA SCS08132528GA AAD06031144GA AAD06071219GA AAD06071220GA AAD06071224GA AAD06111362GA AAD06111406GA AAD06121429GA AAD06121443GA AAD06121444GA AAD06171567GA AAD06171569GA AAD06171571GA AAD06171577GA AAD06171579GA AAD06171580GA AAD06171581GA AAD06171582GA AAD06171583GA AAD06171585GA AAD06181590GA AAD06181591GA AAD06181592GA AAD06181593GA AAD06181594GA AAD06181595GA AAD06181605GA AAD06181606GA AAD06181607GA AAD06181609GA AAD06181610GA AAD06181611GA AAD06181612GA AAD06181613GA AAD06181614GA AAD06181619GA AAD06191620GA AAD06191623GA AAD06191624GA AAD06191625GA AAD06191626GA AAD06191628GA AAD06191629GA AAD06201676GA AAD06201677GA AAD06201678GA AAD06201679GA SCS06430351GA SCS06440369GA SCS06480514GA SCS06480522GA SCS06480524GA SCS06480532GA SCS06480535GA SCS06480536GA SCS06480537GA SCS06480540GA SCS06480545GA SCS06480546GA SCS07080895GA SCS07080902GA SCS07090912GA SCS07171075GA SCS07391700GA SCS07391765GA SCS07391768GA SCS07391771GA SCS07462006GA SCS07522160GA SCS07522162GA SCS07522172GA SCS07522176GA SCS07522177GA SCS07522178GA AAD05210186GA AAD05210187GA AAD05210188GA AAD05220189GA AAD05220190GA AAD05220193GA AAD05430736GA AAD05430738GA AAD05430748GA AAD05430759GA AAD05430779GA AAD05450824GA AAD05450825GA AAD05450831GA AAD05450838GA AAD05450841GA AAD05450844GA AAD05460871GA AAD05521063GA AAD06171517GA AAD06171520GA AAD06332071GA AAD06332074GA AAD06342075GA AAD06342076GA AAD06342077GA AAD06342078GA AAD06342079GA AAD06342080GA AAD06342082GA AAD06342087GA AAD06342090GA AAD06352097GA AAD06352098GA AAD06352099GA AAD06352100GA AAD06352101GA AAD06352102GA AAD06352103GA AAD06352104GA AAD06352105GA AAD06352106GA AAD06352107GA AAD06352108GA AAD06352109GA AAD06352110GA AAD06352111GA AAD06352112GA AAD06352113GA SCS06390193GA SCS07090922GA SCS07110946GA SCS07441908GA SCS07441911GA SCS07441914GA SCS07441916GA SCS07441920GA SCS08242781GA SCS08242783GA SCS08242788GA SCS08242796GA SCS08393114GA SCS08393125GA SCS09173716GA AAD05340459GA AAD05340460GA AAD05340461GA AAD05340462GA AAD05340463GA AAD05340464GA AAD05340466GA AAD05340467GA AAD05340468GA AAD05340469GA AAD05340470GA AAD05340471GA AAD05350472GA AAD05350473GA AAD05350474GA AAD05350475GA AAD05350483GA AAD05350484GA AAD05350486GA AAD05350487GA AAD05350488GA AAD05350489GA AAD05350492GA AAD05350493GA AAD05350497GA AAD05350498GA AAD05350500GA AAD05350501GA AAD05350502GA AAD05360503GA AAD05360504GA AAD05360505GA AAD05360507GA AAD05360537GA AAD05360545GA AAD05380636GA AAD05430746GA AAD05450848GA SCS08202676GA SCS08202682GA SCS09023559GA SCS09023562GA SCS09143686GA SCS09364031GA SCS09364032GA AAD05330445GA AAD05330447GA SCS10174618GA SCS08413185GA SCS08413196GA SCS08423209GA SCS08423218GA SCS08503425GA SCS08503426GA SCS09093627GA SCS09093634GA SCS07391752GA SCS07391761GA SCS07391762GA SCS07391763GA SCS07391769GA SCS07391620GA SCS06500613GA SCS06500629GA SCS07030749GA SCS07030750GA SCS07030751GA SCS07030754GA SCS07030756GA SCS07030761GA SCS07030765GA SCS07040767GA SCS07040768GA SCS07040770GA SCS07040771GA SCS07040774GA SCS07040780GA SCS08373035GA SCS09073615GA SCS09153707GA SCS09454269GA SCS09454276GA SCS06430356GA SCS07171076GA SCS08473332GA SCS08473334GA SCS08473335GA SCS08493336GA SCS09193753GA AAD06041184GA SCS08393127GA SCS08393140GA SCS08132527GA SCS08132530GA AAD05240238GA SCS08042245GA AAD06121423GA AAD06121427GA SCS09153710GA SCS09153714GA AAD05240250GA AAD05250260GA AAD05250265GA SCS08252809GA SCS08252831GA SCS08292869GA SCS08292872GA SCS08363021GA SCS08363025GA SCS08363026GA SCS08373032GA SCS08252837GA SCS08302885GA SCS08302888GA SCS08162607GA SCS08162613GA SCS08172628GA SCS08212710GA SCS08232729GA SCS08242784GA SCS08242787GA SCS08252816GA SCS07171071GA SCS08252807GA SCS08302893GA SCS09283836GA SCS09293855GA SCS09404171GA SCS09404172GA SCS09404173GA SCS09404174GA SCS09404175GA SCS09414180GA SCS09414181GA SCS09414184GA SCS09414185GA SCS09414186GA SCS09414187GA SCS09454263GA SCS07371568GA SCS07371570GA SCS07371573GA SCS07371578GA SCS07371581GA SCS07371584GA SCS07371587GA SCS07371593GA SCS07371595GA SCS07371598GA SCS07381601GA SCS08433264GA SCS08493355GA SCS09023555GA SCS09023556GA SCS09023557GA SCS09023558GA SCS09023560GA SCS09023561GA SCS09143687GA SCS09143688GA SCS09364012GA SCS09364016GA SCS09364024GA SCS09364025GA SCS09364026GA SCS09364028GA SCS09364029GA SCS09364030GA SCS09364035GA SCS09444232GA SCS09444233GA SCS09444235GA SCS09444236GA SCS10144477GA SCS10164593GA SCS06430314GA SCS06430315GA SCS06430316GA SCS06430317GA SCS06430319GA SCS06460480GA SCS06460487GA SCS06460491GA SCS07311436GA SCS07311438GA SCS07311440GA SCS07311441GA SCS07321452GA SCS07321456GA SCS07321457GA SCS07482036GA SCS07482038GA SCS07482045GA SCS07482046GA SCS07502130GA SCS07502131GA SCS07512147GA SCS07512152GA SCS07522156GA SCS07522166GA SCS07522168GA SCS07522170GA SCS07522179GA SCS08012185GA SCS08032221GA SCS08132542GA SCS08132544GA SCS08142568GA SCS08142570GA SCS08142573GA SCS08142574GA SCS08142575GA SCS08142594GA SCS08142598GA SCS08162601GA SCS08162611GA SCS08162612GA SCS08162615GA SCS08162617GA SCS08172625GA SCS08172643GA SCS08182652GA SCS08202666GA SCS08202667GA SCS08202668GA SCS08202672GA SCS08202673GA SCS08202675GA SCS08212690GA SCS08212691GA SCS08212706GA SCS08212707GA SCS08212708GA SCS08222717GA SCS08222718GA SCS08222720GA SCS08222721GA SCS08222722GA SCS08222723GA SCS08222725GA SCS08222726GA SCS08222727GA SCS08232737GA SCS08232738GA SCS08232739GA SCS08232740GA SCS08232743GA SCS08232746GA SCS08232747GA SCS08232748GA SCS08232749GA SCS08232750GA SCS08232751GA SCS08232752GA SCS08242766GA SCS08242767GA SCS08242769GA SCS08242770GA SCS08242771GA SCS08242772GA SCS08242773GA SCS08242778GA SCS08242779GA SCS08252798GA SCS08252813GA SCS08252818GA SCS08292863GA SCS08342960GA SCS08363004GA SCS08363005GA SCS08373044GA SCS08373045GA SCS08373046GA SCS08373048GA SCS08373049GA SCS08373050GA SCS08373051GA SCS08373053GA SCS08373054GA SCS08373055GA SCS08373056GA SCS08373057GA SCS08373059GA SCS08373060GA SCS08373062GA SCS08373063GA SCS08373064GA SCS08373065GA SCS08373066GA SCS08373067GA SCS08373068GA SCS08373069GA SCS08373070GA SCS08373077GA SCS08373078GA SCS09303878GA SCS09303879GA SCS09303880GA SCS09303881GA SCS09303890GA SCS09303891GA SCS09303899GA SCS09464291GA SCS09464301GA SCS09464302GA SCS07431861GA SCS07441910GA SCS07441915GA SCS07371554GA AAD05240222GA AAD05240223GA AAD05240247GA AAD05290346GA AAD05290347GA AAD05521041GA AAD05521043GA AAD05521045GA AAD05521047GA AAD05521048GA AAD05521049GA AAD05521052GA AAD05521057GA AAD06261918GA AAD06261925GA SCS06420288GA SCS06420289GA SCS07391716GA SCS08473280GA SCS08473283GA SCS08473284GA SCS08473288GA SCS08473289GA SCS09113636GA SCS07231351GA SCS07401776GA SCS08352968GA SCS06430293GA SCS06430301GA SCS06430304GA SCS07391744GA SCS07391766GA SCS08042250GA SCS08042251GA SCS08042253GA SCS08312926GA SCS08312929GA SCS08332948GA SCS08332952GA SCS08332953GA SCS08352969GA SCS08352974GA SCS08352979GA SCS09153692GA SCS09153695GA SCS09153696GA SCS07431869GA SCS07441965GA SCS07441967GA SCS07502100GA SCS07502101GA SCS07502102GA SCS07502104GA SCS07502107GA SCS07502108GA SCS07502109GA SCS07502111GA SCS07502112GA SCS07502114GA SCS07502116GA SCS07502118GA SCS07502120GA AAD05350485GA AAD05360509GA AAD05360525GA AAD05360528GA AAD05460857GA AAD05460860GA AAD05460868GA AAD05460869GA AAD05460872GA AAD05460876GA SCS07431845GA SCS07431847GA SCS07431849GA SCS07431851GA SCS07431865GA SCS07431866GA SCS07431867GA SCS07431871GA SCS07431874GA SCS07441923GA SCS07441924GA SCS07441929GA SCS07441932GA SCS07441963GA SCS07441972GA SCS07441975GA SCS07502105GA SCS07502106GA SCS07502110GA SCS07502113GA SCS07502122GA SCS08262842GA AAD05440815GA AAD05440821GA SCS08122502GA SCS08132531GA SCS08132532GA SCS08132534GA SCS08132535GA SCS08132540GA SCS08132551GA SCS08132553GA SCS08132564GA SCS08252801GA SCS08252817GA SCS07391657GA SCS07391658GA SCS07391662GA SCS07391663GA SCS07391666GA SCS07391678GA SCS07391679GA SCS07391682GA SCS07391685GA SCS07391690GA SCS07391759GA AAD05450823GA AAD05450846GA AAD06021113GA AAD06021115GA AAD06021116GA AAD06021124GA AAD06071217GA SCS08172639GA SCS08182654GA SCS09414192GA SCS09434214GA SCS09434215GA SCS10144482GA SCS10144491GA AAD05400725GA SCS09303865GA SCS09303868GA SCS09303873GA SCS09303874GA SCS09303875GA SCS09303876GA SCS09303882GA SCS09303884GA AAD06031141GA AAD06031145GA AAD06171514GA AAD06171515GA AAD06171516GA AAD06171524GA AAD06181608GA AAD06191647GA SCS06500655GA SCS06510664GA SCS06510668GA SCS06510680GA SCS07030743GA SCS07030748GA SCS08122497GA SCS08172635GA SCS08182653GA SCS08182655GA SCS09404161GA SCS07482056GA AAD05290344GA AAD05290345GA AAD05510979GA AAD05510981GA AAD06241800GA AAD06241803GA AAD06241805GA AAD06241810GA AAD06251825GA AAD06251829GA SCS08162609GA SCS08302896GA SCS08302897GA SCS09033569GA SCS09053600GA SCS09053601GA SCS09053613GA SCS09053614GA SCS09303888GA SCS07231327GA SCS07231339GA SCS07231342GA SCS07231344GA SCS08262850GA SCS08142582GA SCS08493353GA SCS08493356GA SCS08493379GA SCS09344004GA SCS09344006GA SCS09364014GA SCS09364021GA SCS08132546GA SCS07311407GA SCS08413174GA SCS08413177GA SCS07321446GA SCS07321451GA SCS07411803GA SCS07421816GA SCS07421822GA AAD06071235GA AAD06071236GA AAD06071237GA AAD06071246GA AAD06071247GA AAD06071248GA AAD06091261GA AAD06091276GA SCS07431864GA SCS07431875GA AAD06362121GA AAD06362130GA AAD06362131GA AAD06362132GA AAD06362133GA AAD06362134GA AAD06372147GA AAD06372148GA AAD06372149GA AAD06372150GA AAD06372152GA AAD06372154GA AAD06372155GA AAD06372156GA AAD06372157GA AAD06111370GA AAD06121458GA SCS07080873GA SCS07080881GA SCS07080889GA SCS07080893GA AAD05330442GA AAD06121447GA AAD06121448GA AAD06121451GA AAD06121452GA AAD06121454GA SCS06430325GA SCS08142589GA SCS08142591GA SCS08162604GA SCS08162605GA SCS08162608GA SCS08162614GA SCS08162616GA SCS08162618GA SCS08162619GA SCS08162622GA SCS08172627GA SCS08172629GA SCS08172632GA SCS08202681GA SCS08202683GA SCS08212701GA SCS08212702GA SCS08212703GA SCS08212704GA SCS08413175GA SCS08413178GA SCS08413179GA SCS08413180GA SCS08413181GA SCS08413182GA SCS08413183GA SCS08413184GA SCS08413192GA SCS08413193GA SCS08443279GA AAD05430735GA AAD05430765GA AAD05521040GA AAD05521060GA AAD05521061GA AAD05521062GA AAD05521064GA AAD05521065GA AAD05521069GA AAD05521073GA AAD05521075GA AAD05521079GA AAD05521080GA AAD05521081GA AAD05521082GA AAD06111413GA AAD06171526GA AAD06171528GA AAD06171530GA AAD06171533GA AAD06171534GA AAD06171535GA SCS07060830GA SCS09113641GA SCS07512141GA SCS07522155GA AAD06041191GA SCS08132548GA SCS08132549GA SCS08493374GA SCS09203782GA SCS07381608GA SCS07381612GA SCS07381613GA SCS07381614GA SCS09283829GA SCS09283833GA SCS09293839GA SCS10164599GA SCS10164605GA SCS10164615GA AAD05370589GA AAD05370590GA AAD06111403GA AAD06111409GA AAD06111411GA AAD06111420GA SCS09203773GA SCS09203775GA SCS09203776GA SCS09233791GA SCS09243810GA SCS09243811GA SCS09243816GA SCS09293851GA SCS09293856GA SCS09293858GA SCS09323928GA SCS09323932GA SCS09333953GA SCS06480501GA SCS09053603GA SCS09053606GA SCS09053607GA SCS09053608GA SCS09434225GA SCS09434226GA SCS07361539GA SCS07371548GA SCS07371555GA SCS07371560GA SCS08012198GA AAD06261932GA AAD06291956GA SCS06480520GA SCS07020726GA SCS07020732GA SCS07020735GA SCS07110950GA SCS07110954GA SCS07110969GA SCS07110983GA SCS07171100GA SCS07201185GA SCS07201187GA SCS07201188GA SCS07371591GA SCS07371596GA AAD06061214GA AAD05430739GA AAD05430763GA SCS07231325GA AAD05500960GA AAD05500963GA AAD05500964GA AAD05500965GA AAD05500966GA AAD05500967GA AAD05510978GA AAD05510980GA AAD05510983GA AAD06101294GA AAD06101295GA AAD06251818GA AAD06251819GA AAD06251820GA AAD06251823GA AAD06251824GA SCS07462011GA SCS09303897GA SCS09313911GA SCS09313912GA SCS09313913GA SCS09093631GA SCS09153697GA SCS09153698GA SCS09153699GA SCS09153703GA SCS06440405GA SCS07381604GA SCS07391641GA AAD05360514GA AAD05360515GA AAD05360516GA AAD05360517GA AAD05360518GA AAD05360526GA AAD05360527GA AAD06101318GA SCS09243809GA SCS09323924GA SCS09323927GA SCS09323940GA SCS09333960GA SCS09333965GA SCS09333976GA SCS09333980GA SCS09333983GA SCS09333984GA SCS09333985GA SCS09333986GA AAD05300388GA AAD05300389GA SCS10074430GA SCS08373030GA SCS08373031GA SCS08373082GA SCS08383092GA SCS08493384GA SCS08493385GA SCS08493386GA SCS09404169GA SCS09404170GA SCS09414178GA SCS09524402GA SCS09524405GA SCS07461985GA AAD05250271GA AAD06221763GA AAD06231797GA SCS07181159GA SCS08112443GA SCS08112449GA SCS08373058GA SCS08373079GA SCS09364027GA SCS08072324GA SCS08082341GA SCS08082343GA SCS08082358GA SCS08292875GA SCS08112441GA AAD05200173GA AAD05200176GA AAD05210184GA AAD05210185GA AAD05390661GA AAD05390662GA AAD05400727GA AAD06091275GA SCS07030760GA SCS08012195GA SCS09514364GA SCS09514368GA AAD05260299GA SCS06480542GA SCS07080872GA SCS07080874GA AAD05450836GA SCS08172644GA SCS08493373GA SCS09344003GA SCS09514362GA SCS09514372GA SCS10074425GA SCS07171108GA SCS08252805GA SCS08262843GA SCS09153691GA SCS09153693GA SCS07482089GA AAD05260306GA SCS08032223GA SCS08032227GA SCS08212697GA SCS08423250GA SCS08433261GA SCS09404160GA SCS09404162GA SCS07431862GA SCS07461978GA SCS07461997GA SCS10164598GA SCS10164603GA SCS10174621GA SCS10174630GA SCS10074432GA SCS10084448GA SCS10084451GA AAD05230197GA AAD05230198GA AAD05500954GA AAD05500955GA AAD05500957GA AAD05500958GA AAD06171527GA AAD06171537GA AAD06181615GA AAD06191621GA AAD06191632GA AAD06191635GA AAD06191648GA AAD06191650GA AAD06191653GA SCS06510676GA SCS06510678GA SCS07151038GA SCS07151042GA SCS07181126GA SCS07181140GA SCS07221310GA SCS07221312GA SCS07221321GA SCS07311416GA SCS07311434GA SCS07311435GA SCS07331490GA SCS07361522GA SCS07431876GA SCS07431877GA SCS07431878GA SCS07441941GA SCS07441944GA SCS07441958GA SCS07441973GA SCS07482049GA SCS07482052GA SCS07482053GA SCS07482065GA SCS07482067GA SCS07482068GA SCS07482069GA SCS07482071GA SCS07502125GA SCS07502127GA SCS07502128GA SCS07512143GA SCS07512151GA SCS08232736GA SCS08232756GA SCS08332943GA SCS08332944GA SCS08352967GA SCS08352976GA SCS08352983GA SCS08413188GA SCS08413189GA SCS08413197GA SCS08413198GA SCS08473281GA SCS08473282GA SCS08473285GA SCS08473286GA SCS08473287GA SCS08473291GA SCS08473298GA SCS08473300GA SCS08473303GA SCS08473304GA SCS08473305GA SCS08473309GA SCS08473311GA SCS08473314GA SCS08473317GA SCS08473319GA SCS08473322GA SCS08473330GA SCS08473333GA SCS09133670GA SCS09143671GA AAD06051199GA SCS08292865GA AAD05240239GA SCS07441927GA SCS07441955GA SCS07441956GA SCS07441957GA SCS08092386GA SCS08102391GA SCS08112428GA SCS08112431GA AAD06071251GA SCS07482041GA SCS07482088GA SCS07502103GA SCS07502115GA SCS07502117GA SCS07502119GA SCS07502121GA SCS07502123GA SCS07502124GA SCS07502126GA SCS08092387GA SCS08102396GA SCS09143683GA SCS06420280GA SCS06420290GA SCS08493383GA SCS08493388GA SCS08493394GA SCS08493397GA SCS08493401GA SCS08493419GA SCS08493420GA SCS08503428GA SCS08503430GA SCS08503431GA SCS09384101GA SCS09384107GA SCS09384108GA SCS09384109GA SCS09384110GA SCS09384111GA SCS09384112GA SCS09384114GA SCS09384117GA SCS09384118GA SCS09384120GA SCS09384123GA SCS09464288GA SCS09464304GA SCS09464309GA SCS08302884GA SCS08302895GA AAD06101312GA AAD06101313GA AAD06121439GA AAD06121440GA AAD06322037GA AAD06322038GA AAD06322039GA AAD06322040GA AAD06322042GA AAD06322044GA AAD06322050GA AAD06332051GA AAD06332052GA AAD06332055GA AAD06332059GA AAD06332060GA AAD06332061GA AAD06332064GA AAD06332066GA AAD06332070GA AAD06332072GA AAD06332073GA SCS07221302GA SCS07321442GA SCS07321450GA SCS08172638GA AAD05400718GA AAD05400719GA AAD05400720GA AAD05400721GA SCS07391668GA SCS09173730GA AAD06342086GA AAD06352094GA SCS06500633GA SCS06500634GA SCS06510681GA SCS07391650GA SCS07391712GA SCS07391718GA SCS10174632GA SCS06430327GA AAD05430766GA AAD05430769GA AAD05430774GA AAD05440804GA AAD05440805GA AAD05440808GA AAD05440810GA AAD05440811GA AAD05440812GA AAD05510982GA AAD05510988GA SCS07070842GA SCS07070844GA SCS08473326GA SCS08473329GA SCS09043587GA SCS08413190GA SCS08413207GA AAD05250274GA SCS07291400GA SCS08122488GA AAD06141490GA AAD06211743GA SCS07080885GA SCS08423213GA SCS08423214GA SCS08493345GA SCS08493378GA SCS08493404GA SCS09323930GA SCS09323935GA SCS09323937GA SCS09394125GA SCS09394128GA SCS09394133GA SCS09333950GA SCS09333966GA SCS10144497GA SCS10144503GA SCS07401780GA AAD06362126GA SCS06440399GA SCS06440402GA SCS06440416GA SCS06460456GA SCS06460457GA SCS06460458GA SCS06460464GA SCS06460474GA SCS06460475GA SCS06460476GA SCS06460479GA SCS06460482GA SCS06460483GA SCS06460492GA SCS06460497GA SCS06460499GA SCS08423240GA SCS08423245GA AAD06111359GA SCS07141029GA SCS08393116GA SCS08393146GA SCS09303877GA SCS08513452GA SCS08513457GA SCS09283830GA SCS09283831GA SCS09283832GA SCS08112438GA SCS08112480GA SCS08122501GA SCS08122511GA SCS08122512GA SCS08132537GA SCS08132541GA SCS08142569GA SCS08423246GA SCS08423247GA SCS08433262GA SCS09384038GA SCS09384039GA SCS09384045GA AAD05260326GA SCS07411792GA SCS07221294GA SCS07221300GA SCS09093628GA SCS09093632GA AAD05500948GA SCS07211268GA SCS07221319GA SCS06390152GA SCS06390175GA SCS06390188GA SCS06390190GA SCS07391645GA SCS07391648GA SCS06460478GA SCS06460486GA SCS07050814GA SCS09464282GA SCS09464287GA SCS10164594GA SCS10164601GA AAD05430783GA SCS09183737GA SCS09183738GA SCS09203786GA SCS09384052GA AAD05200177GA AAD06231795GA SCS07391713GA SCS08022217GA SCS08052271GA SCS08212696GA SCS07411798GA SCS08092380GA SCS09043585GA SCS09043589GA SCS10144514GA SCS10144515GA SCS10144517GA SCS10144534GA SCS10144539GA SCS10144540GA SCS10214655GA SCS10214656GA SCS10224666GA SCS10224673GA SCS10224679GA SCS10224703GA SCS06390143GA SCS06390151GA SCS06500615GA SCS06500619GA SCS08202685GA AAD05330441GA AAD06181596GA AAD06181597GA AAD06181616GA AAD06181618GA AAD06191627GA AAD06191630GA SCS07391770GA SCS07431848GA SCS08373043GA SCS09203781GA SCS07492093GA SCS07492094GA SCS07141005GA SCS07151044GA SCS07161058GA SCS07161068GA SCS07161070GA SCS07311412GA SCS08232745GA SCS06480508GA SCS06480512GA SCS08473323GA SCS09293844GA SCS09384053GA SCS09384054GA AAD06021109GA SCS07311409GA SCS07311410GA SCS09524406GA SCS09524407GA SCS09524410GA AAD05380621GA AAD05380622GA AAD06261904GA AAD06261908GA AAD06261919GA AAD06261934GA AAD06281935GA AAD06281936GA AAD06281939GA AAD06281946GA AAD06291959GA AAD06291968GA AAD06291970GA AAD06291973GA AAD06291982GA AAD06291983GA SCS06430312GA SCS06430332GA SCS06460463GA SCS07020727GA SCS07020729GA SCS07050792GA SCS07050807GA SCS07050809GA SCS07050810GA SCS07050811GA SCS07110976GA SCS07110984GA SCS08072337GA SCS08092371GA SCS08092373GA SCS08493405GA SCS09434227GA SCS09434228GA AAD06031128GA AAD06031131GA SCS07431850GA SCS08383098GA SCS08383100GA AAD05380638GA AAD05380639GA SCS08232734GA SCS08232741GA SCS09444252GA SCS09444253GA SCS09444254GA SCS09454259GA SCS09454280GA AAD05460883GA SCS09293846GA AAD05390710GA AAD05460865GA AAD06151493GA SCS06430335GA SCS06500656GA SCS07080887GA SCS07161056GA SCS07181110GA SCS07181111GA SCS07181114GA SCS07181116GA SCS07181120GA SCS07181121GA SCS07181123GA SCS07181125GA SCS07181129GA SCS07181132GA SCS07181133GA SCS07181137GA SCS07181139GA SCS07201208GA SCS07201212GA SCS07201214GA SCS07201215GA SCS07201216GA SCS07201217GA SCS07201218GA SCS07201221GA SCS07201222GA SCS07201223GA SCS07201224GA SCS07201226GA SCS07201227GA SCS07201233GA SCS07201235GA SCS07201236GA SCS07201239GA SCS07201240GA SCS07201241GA SCS07201242GA SCS07201243GA SCS07201244GA SCS07201247GA SCS07201248GA SCS07211250GA SCS07211251GA SCS07211256GA SCS07211257GA SCS07211259GA SCS07211260GA SCS07211261GA SCS07211265GA SCS07211266GA SCS07211267GA SCS07211269GA SCS07211271GA SCS07211273GA SCS07211274GA SCS07211275GA SCS07231353GA SCS07231354GA SCS07231355GA SCS07231356GA SCS07231357GA SCS07291376GA SCS07291377GA SCS07291378GA SCS07291379GA SCS07291389GA SCS07371541GA SCS08302912GA SCS08312934GA SCS07391738GA SCS07391740GA SCS07391749GA SCS07431844GA AAD05240253GA AAD05240254GA AAD05240255GA AAD05250256GA AAD05250257GA AAD05250258GA AAD05250259GA AAD05250264GA SCS08503424GA SCS08503438GA SCS08503439GA SCS08503448GA SCS09333968GA SCS09394126GA SCS09394138GA SCS07331493GA SCS07331495GA SCS07331496GA SCS07331497GA SCS07331498GA SCS07331499GA SCS07331500GA SCS07331501GA SCS08082366GA SCS08082369GA SCS09113635GA SCS08302901GA SCS08302905GA SCS08332950GA SCS07050801GA SCS07050816GA SCS08423251GA SCS08423254GA SCS09384036GA SCS09384040GA SCS09384043GA SCS08413202GA SCS08423225GA SCS08423227GA SCS08433256GA SCS08433257GA SCS08433258GA SCS08352962GA SCS08352963GA SCS08352965GA SCS08352966GA SCS08352977GA SCS08352978GA SCS08352981GA SCS08352984GA SCS08352986GA SCS08352987GA SCS08352988GA SCS08362995GA SCS08363000GA SCS08363001GA SCS08363006GA SCS08363007GA SCS08332955GA SCS08342957GA SCS07211278GA AAD05250268GA AAD05250269GA AAD05250277GA SCS08102415GA SCS08102423GA SCS09394124GA SCS09394127GA SCS09394129GA SCS09394136GA SCS08302894GA SCS08433260GA SCS09173731GA SCS07431839GA SCS07431868GA SCS07441974GA SCS07461981GA SCS07461983GA SCS07461984GA SCS07492095GA SCS07492097GA SCS08012186GA SCS08022204GA SCS08022206GA SCS08062307GA SCS08082352GA SCS08082370GA SCS08102409GA SCS08112454GA SCS08302886GA SCS08312928GA SCS08373073GA SCS08383083GA SCS08383084GA SCS08383085GA SCS08383086GA SCS08383089GA SCS08413206GA SCS08413208GA SCS08423212GA SCS08423249GA SCS08493359GA SCS08503446GA SCS08503450GA SCS08513465GA SCS09384113GA SCS09384116GA SCS09384121GA SCS10154556GA SCS10234706GA SCS07482015GA AAD06181588GA SCS08493354GA SCS08493362GA SCS09093625GA SCS09093629GA SCS09093633GA SCS07171090GA SCS08292878GA SCS08493402GA SCS08493403GA SCS09414183GA SCS08352964GA SCS08363003GA SCS08393119GA SCS07391623GA SCS08352971GA SCS08352982GA SCS08362990GA SCS08363016GA

SCS08373036GA SCS08373037GA SCS08373040GA SCS09053609GA SCS09053610GA SCS08172636GA SCS08102420GA SCS08112460GA SCS08122505GA SCS07421826GA SCS06390102GA SCS06390103GA SCS06390104GA SCS06390112GA SCS07421818GA SCS07421819GA SCS07421823GA SCS07421827GA SCS08292874GA SCS08292882GA SCS09414177GA SCS09414179GA SCS07221311GA SCS07221314GA SCS07321453GA SCS07391632GA SCS07411804GA SCS07411806GA SCS07411807GA SCS07411809GA SCS07411810GA SCS07411811GA SCS07411814GA SCS07411815GA SCS07421829GA SCS08172646GA SCS08182657GA SCS08202688GA SCS08222715GA SCS08242765GA SCS08242792GA SCS08503421GA SCS08503436GA SCS09384041GA SCS09384047GA AAD06151496GA SCS09394130GA SCS09394132GA SCS09394137GA SCS09394139GA SCS09394140GA SCS09394144GA SCS09394146GA SCS06480525GA SCS10174640GA SCS10174649GA SCS10174652GA SCS08052273GA SCS08052279GA SCS08052283GA SCS08052289GA SCS08062297GA SCS08062298GA SCS09344005GA SCS09344007GA SCS09344008GA SCS09364013GA SCS09364017GA SCS09364019GA SCS09364020GA SCS09364022GA SCS09364023GA SCS09364033GA SCS09364034GA SCS09384037GA AAD06061208GA SCS09384115GA SCS09384119GA AAD05500945GA AAD05500947GA AAD05521066GA AAD05521067GA SCS08172630GA SCS09514389GA SCS10164606GA AAD06171565GA AAD06171570GA AAD06171572GA AAD06231798GA SCS09243808GA SCS09243812GA AAD06301990GA AAD06302000GA SCS09173729GA SCS09424206GA SCS06500643GA SCS07522161GA SCS07522169GA SCS08012188GA SCS08022216GA SCS08032229GA SCS08032238GA SCS08032239GA SCS08082351GA SCS08092377GA SCS08102389GA SCS08132543GA SCS10144480GA SCS10154553GA SCS10154554GA SCS10154557GA SCS08413166GA SCS08413167GA SCS08413176GA SCS08413187GA SCS08413191GA SCS08413199GA SCS09464290GA SCS09464297GA SCS09504350GA SCS09504351GA SCS09504352GA SCS09504353GA SCS09504355GA SCS09504356GA SCS09504358GA SCS09504359GA SCS09504360GA SCS09504361GA SCS10174619GA SCS09303872GA AAD06061215GA AAD05230194GA AAD05230199GA AAD05230200GA AAD05230201GA SCS07431836GA SCS07431838GA SCS07431870GA SCS07441976GA SCS07482048GA SCS07482070GA SCS07482072GA SCS07482073GA SCS07482074GA SCS07482075GA SCS07482076GA SCS07482079GA SCS07482090GA SCS07482091GA SCS07482092GA SCS07502133GA SCS07502135GA SCS07512142GA SCS07512146GA SCS07512149GA SCS08312937GA SCS08312941GA SCS08342959GA SCS08342961GA SCS08493418GA SCS07461982GA AAD05370575GA AAD05370576GA AAD05370579GA AAD05370580GA AAD05370581GA AAD05370582GA AAD05370583GA AAD05370584GA AAD05370591GA AAD05370592GA AAD05370593GA AAD05370594GA AAD05370595GA AAD05370596GA AAD06071250GA AAD06372161GA AAD06372164GA SCS06390114GA SCS06390115GA SCS06390117GA SCS07030762GA SCS07030763GA SCS07070848GA SCS07070850GA SCS07070852GA SCS07070853GA SCS07070854GA SCS07070855GA SCS07070858GA SCS07070864GA SCS07080876GA SCS07080880GA SCS07110963GA SCS07110967GA SCS07361517GA SCS09293842GA SCS09293860GA SCS08493389GA SCS09313910GA AAD06261877GA AAD06261878GA AAD06261881GA AAD06261886GA AAD06261896GA AAD06291974GA AAD06291975GA AAD06291976GA AAD06291977GA AAD06291978GA SCS07060828GA SCS07060831GA SCS09043581GA SCS09043583GA SCS09043584GA SCS08042260GA SCS07391714GA AAD06171554GA SCS07070843GA SCS07070847GA SCS07431863GA SCS08112473GA SCS08142592GA AAD06091263GA AAD06091269GA AAD06091274GA AAD06091278GA SCS09384097GA SCS09514396GA SCS09514397GA SCS07401775GA SCS06490570GA SCS07482037GA SCS07482043GA AAD05380615GA AAD06091277GA AAD06091280GA SCS06390171GA SCS06390173GA SCS08252820GA SCS08312925GA SCS08312927GA SCS08423211GA SCS08423215GA SCS08423216GA SCS08423219GA SCS08072336GA SCS08162600GA SCS08172640GA SCS06520708GA SCS07010722GA SCS09514375GA SCS09514381GA SCS09514384GA SCS07381610GA SCS07381611GA SCS07391617GA SCS07391618GA SCS07391621GA SCS07391622GA SCS07391624GA SCS07391630GA SCS07391634GA SCS07391636GA SCS09454257GA SCS09454272GA SCS09454273GA SCS09454274GA SCS09454275GA AAD06031151GA AAD06031152GA SCS06440390GA SCS06460500GA SCS06480507GA SCS06480534GA SCS06480557GA SCS06480563GA SCS06480566GA SCS07020733GA SCS07030741GA SCS07291401GA SCS08493375GA SCS09133654GA SCS09133660GA SCS09153690GA SCS09153694GA SCS09293849GA SCS09384102GA SCS09384105GA SCS08262849GA SCS08292879GA SCS08292880GA SCS08292881GA SCS06440382GA SCS06460473GA SCS07391747GA SCS08292877GA SCS08302887GA SCS08493415GA SCS07391695GA SCS08383101GA SCS09474340GA AAD05320427GA AAD05320428GA AAD05521042GA AAD06111372GA AAD06111377GA SCS07371577GA SCS07371580GA SCS07371586GA SCS07371588GA SCS07371589GA SCS07371594GA SCS08212711GA SCS08383103GA SCS08383104GA SCS08383106GA SCS08383108GA SCS08383109GA SCS08383111GA SCS08393117GA SCS08393118GA SCS08413168GA SCS08142567GA AAD06101317GA AAD06101321GA AAD06101323GA SCS08332945GA SCS08352970GA SCS08352973GA SCS07291380GA SCS07291382GA SCS07291386GA SCS07371571GA SCS07371575GA SCS07371579GA SCS07371590GA SCS07431832GA SCS07431833GA SCS07431834GA SCS07431835GA SCS07431837GA SCS07431856GA SCS07441925GA SCS07441933GA SCS07461988GA SCS07461989GA SCS07492096GA SCS08042256GA SCS08042257GA SCS08042258GA SCS08042259GA SCS08052265GA SCS08052267GA SCS08052268GA SCS08052269GA SCS08052275GA SCS08062299GA SCS08102398GA SCS08252800GA SCS08252808GA SCS08252811GA SCS08252835GA SCS08262847GA SCS08262848GA SCS08332951GA SCS08332954GA SCS08503441GA SCS09404165GA SCS09404166GA SCS09404167GA SCS09404168GA AAD06051198GA SCS06430300GA SCS06430302GA SCS06430303GA SCS06430307GA SCS07030755GA SCS07030757GA SCS07462007GA SCS08082346GA SCS08082349GA SCS08082355GA SCS08092372GA SCS08092376GA SCS08122492GA SCS08493377GA SCS10074429GA SCS10074436GA SCS06420277GA SCS06420286GA SCS07391619GA SCS07391626GA SCS07391640GA SCS08252802GA SCS07391665GA SCS07391674GA SCS07391676GA SCS07391684GA SCS07391688GA SCS07482024GA SCS07482027GA AAD06031140GA SCS08362992GA SCS08363014GA SCS08312933GA SCS08503445GA SCS08513455GA SCS08513459GA SCS09263817GA SCS09293847GA SCS09333961GA SCS10164608GA SCS10164609GA SCS10164612GA SCS10164616GA SCS10174643GA SCS10174644GA SCS10174646GA SCS10174650GA SCS06430341GA SCS06440367GA SCS06440373GA SCS07070863GA SCS07311415GA SCS07311425GA SCS07311432GA SCS08423253GA SCS09143681GA SCS09143682GA SCS09143684GA SCS07231343GA SCS07231345GA SCS07231346GA SCS07231349GA SCS08132522GA AAD06261913GA SCS08222719GA SCS08242763GA SCS08292851GA SCS08292857GA SCS08292858GA SCS08292859GA SCS08292861GA SCS08302883GA SCS08302898GA SCS08302899GA SCS08312913GA SCS08312915GA SCS07311430GA SCS07311431GA SCS07090921GA SCS07090923GA SCS08112436GA SCS08112439GA SCS10084445GA SCS10084447GA SCS08473316GA AAD05521092GA AAD05350499GA AAD05380647GA AAD05380648GA AAD05380649GA AAD05380650GA AAD05380651GA AAD05380652GA AAD05390653GA AAD05390654GA AAD05521094GA SCS09384088GA SCS09384094GA SCS08082357GA SCS10144468GA SCS10144508GA SCS10154571GA SCS09444249GA AAD05310397GA SCS08072318GA SCS08072331GA SCS08072332GA SCS08082348GA SCS08082350GA SCS08102394GA SCS08232742GA SCS09424203GA SCS09424204GA SCS10164596GA SCS08262844GA SCS08302889GA SCS08302891GA SCS08302892GA SCS07120988GA SCS07120989GA SCS07161061GA SCS07161063GA SCS08122504GA SCS09133656GA AAD06251822GA SCS08493367GA SCS08473328GA SCS08493371GA SCS08493381GA SCS08493391GA SCS08493396GA SCS06430334GA SCS06440364GA SCS06440370GA SCS06440411GA SCS07461999GA SCS07462004GA SCS07462005GA SCS07462012GA SCS07482019GA SCS07482023GA SCS07482025GA SCS07482030GA SCS08042244GA SCS09303889GA AAD05240202GA AAD05240203GA AAD05240204GA SCS07080867GA SCS08473315GA SCS08473318GA SCS09133646GA SCS09133649GA SCS09133652GA AAD05430784GA AAD05430789GA AAD05430790GA AAD05430791GA AAD05430792GA AAD05430793GA AAD05430795GA AAD05430799GA AAD05430800GA AAD05430801GA AAD05430802GA AAD05440807GA AAD05440809GA AAD05440813GA AAD05440818GA AAD05440819GA SCS06390105GA SCS06390106GA SCS06390107GA SCS06390108GA SCS10074427GA SCS08112451GA SCS09384086GA SCS08493376GA SCS09133664GA SCS09133666GA SCS09424212GA SCS09404159GA SCS09424213GA AAD05450832GA AAD05450833GA SCS07060819GA SCS07060839GA SCS08433268GA SCS09153712GA SCS10164607GA SCS09193749GA SCS09303864GA SCS09303869GA SCS09303871GA AAD05250284GA AAD05430758GA AAD05430794GA AAD05430796GA AAD06191638GA SCS06430344GA SCS07411791GA SCS08423229GA SCS06390147GA SCS06390156GA SCS06390160GA SCS06390166GA SCS09414188GA SCS09414189GA SCS09414190GA SCS09414191GA SCS09414193GA SCS09414194GA SCS09414195GA SCS09414196GA SCS09414197GA SCS09414198GA SCS09414199GA SCS09424200GA SCS09414182GA SCS08423221GA SCS08423224GA SCS08042263GA SCS08242780GA SCS07231326GA SCS08082365GA SCS08032228GA AAD06131465GA SCS07461980GA SCS07461990GA SCS07461991GA SCS07522157GA SCS07522158GA SCS07522164GA SCS07522171GA SCS07522175GA SCS07522181GA SCS07522182GA SCS08012194GA SCS08042261GA SCS08493347GA SCS08493351GA SCS10164600GA SCS08423243GA SCS08423244GA SCS08493370GA SCS08423232GA SCS08443275GA SCS08363022GA SCS08383093GA SCS08383094GA SCS08383096GA SCS08383099GA SCS10144455GA SCS10144467GA AAD05310421GA AAD05310422GA AAD05310423GA AAD05320426GA AAD05480903GA AAD06241801GA SCS07201228GA SCS07201230GA SCS07231332GA SCS07231336GA SCS07231348GA SCS07522159GA SCS07522167GA SCS07522180GA SCS07522183GA SCS07522184GA SCS08012187GA SCS08012190GA SCS08012191GA SCS08022201GA SCS08022202GA SCS08182651GA SCS08202686GA SCS07441962GA SCS07482084GA SCS07482087GA SCS09434217GA SCS09434218GA SCS09434219GA SCS10214653GA SCS10214654GA SCS06430349GA SCS08362991GA SCS08362996GA SCS09033577GA SCS09033578GA SCS09043592GA SCS09043594GA AAD06171523GA SCS08312930GA SCS09053602GA SCS09053605GA SCS09323941GA AAD05430778GA AAD05500939GA AAD05500952GA AAD06312017GA AAD06312019GA AAD06312020GA AAD06312024GA AAD06312031GA AAD06312035GA SCS06500660GA SCS08413186GA SCS08413195GA SCS08423210GA SCS09404176GA SCS10144463GA SCS10144522GA SCS10144527GA SCS10144529GA SCS10144530GA SCS10144536GA SCS06440386GA SCS06460466GA SCS06460472GA SCS06460488GA SCS06460489GA SCS08032222GA SCS08032226GA SCS08032230GA SCS08032231GA SCS08032232GA SCS08032233GA SCS08042246GA SCS08042247GA SCS08062296GA SCS07151036GA SCS07151043GA SCS07201189GA SCS07201195GA SCS07201220GA SCS07361535GA SCS07371574GA SCS07391721GA SCS07411799GA SCS07421820GA SCS07441940GA SCS07441952GA SCS08062305GA SCS08112462GA SCS08122494GA SCS08292855GA SCS08292860GA SCS08292866GA SCS08292868GA SCS08302902GA SCS08302903GA SCS08302904GA SCS08302906GA SCS08312916GA SCS08312918GA AAD06241804GA SCS06430361GA SCS06430363GA SCS08393112GA SCS08393121GA SCS08393155GA SCS09053599GA SCS09073616GA SCS09173717GA SCS09173728GA SCS09303894GA SCS09303895GA SCS09303898GA SCS09303901GA SCS09303902GA SCS09303903GA SCS09303904GA SCS09333957GA SCS09424205GA SCS09424208GA SCS09424209GA SCS09424210GA SCS09424211GA SCS09434229GA SCS09524412GA SCS10144473GA SCS10224676GA SCS10224677GA SCS10224680GA SCS10224681GA SCS10224683GA SCS08252836GA SCS09153711GA SCS09333973GA SCS09333974GA SCS09333981GA SCS08292862GA SCS08342958GA SCS08503433GA SCS09073618GA SCS09073620GA SCS09193754GA SCS09193755GA SCS09323938GA SCS09333975GA SCS09434220GA SCS09434221GA SCS09434222GA SCS09434223GA SCS09434224GA SCS09444243GA SCS09444244GA SCS09444245GA SCS09444246GA SCS09444247GA SCS09454262GA SCS09474312GA SCS09524408GA SCS09524409GA SCS09524411GA SCS10144494GA SCS10144543GA SCS10154566GA AAD06312032GA SCS08503444GA SCS08503449GA SCS09293841GA SCS09303862GA SCS09303863GA SCS09303866GA SCS09303867GA SCS09303870GA SCS09323916GA SCS09323917GA SCS09323919GA SCS09323920GA SCS09323933GA SCS09323936GA SCS09323939GA SCS09323942GA SCS09333943GA SCS09333944GA SCS09333945GA SCS09333946GA SCS09333947GA SCS09333948GA SCS09333949GA SCS09333951GA SCS09333952GA SCS09333954GA SCS09333955GA SCS09333959GA SCS09333962GA SCS09333969GA SCS09333970GA SCS09333972GA SCS09344011GA SCS09384044GA SCS09384046GA SCS09384048GA SCS10144518GA SCS10144523GA SCS10144524GA SCS10144528GA SCS10144532GA SCS10144535GA SCS10144537GA SCS10144538GA SCS10144542GA SCS10144521GA AAD05240225GA AAD05240229GA AAD05240231GA SCS06500622GA SCS07110956GA SCS07391735GA SCS07401774GA SCS07411790GA SCS07421824GA SCS08052285GA SCS08052286GA SCS08052287GA SCS08062309GA SCS08062310GA SCS08062313GA SCS08072322GA SCS08072327GA SCS08072333GA SCS08072335GA AAD05500944GA SCS07191170GA SCS07231341GA SCS08503440GA SCS09073617GA SCS09153706GA SCS09454264GA SCS10144470GA AAD05370561GA AAD05370562GA SCS08252838GA SCS07040788GA SCS07421821GA SCS08042248GA SCS08042249GA SCS08052266GA SCS08052276GA SCS08062294GA SCS08112433GA SCS08112440GA SCS08112446GA SCS08112448GA SCS08112452GA SCS08112453GA SCS08112458GA SCS08112481GA SCS08122496GA SCS08122519GA SCS08122520GA SCS08132526GA SCS08132545GA SCS08132547GA SCS08132550GA SCS08132560GA SCS08132563GA SCS08142579GA SCS08202671GA SCS08262846GA SCS08423231GA SCS09133653GA SCS09173723GA SCS09173725GA SCS09173727GA SCS10074438GA SCS10074440GA SCS10144483GA SCS10144493GA SCS08132523GA SCS07411796GA SCS08212714GA SCS08413203GA SCS10174647GA AAD06332058GA SCS07040789GA SCS07191168GA SCS07191175GA SCS07391680GA SCS07411782GA SCS07431840GA SCS07431846GA SCS08032220GA SCS08122518GA SCS08373076GA SCS09313905GA SCS09313908GA SCS10084441GA AAD06171538GA AAD06171541GA SCS09444237GA SCS09444240GA SCS09444241GA SCS09444242GA SCS09454277GA SCS09514366GA SCS09514371GA SCS10074434GA SCS10084442GA SCS10084444GA SCS10084446GA SCS10144512GA SCS10154562GA SCS10164610GA SCS10174620GA SCS10174626GA SCS10174641GA SCS10174642GA SCS10224695GA SCS09033565GA SCS09033566GA SCS09033567GA SCS09033568GA SCS09033570GA SCS09033572GA SCS09033573GA SCS09033575GA SCS09033576GA SCS09033579GA SCS09043580GA SCS09043586GA SCS09043593GA SCS09053595GA SCS09053596GA SCS09053598GA AAD05240237GA SCS06380052GA SCS06380065GA SCS06440426GA SCS06440444GA SCS06460462GA SCS07231335GA SCS07371583GA SCS07381607GA SCS07381609GA SCS07391710GA SCS07391720GA SCS07391730GA SCS07391731GA SCS07391767GA SCS07401773GA SCS08503422GA SCS08513460GA SCS09333977GA SCS09333978GA SCS09384042GA SCS08393130GA SCS07421830GA SCS08373047GA SCS08172631GA SCS08172634GA AAD06111367GA AAD06121457GA SCS07411797GA SCS07411801GA SCS07411812GA SCS07411813GA SCS07421825GA SCS07421828GA SCS08132529GA SCS08142593GA SCS08142596GA SCS08242786GA SCS08252799GA SCS09524417GA SCS09183740GA SCS08102421GA SCS07381605GA SCS07381606GA SCS08082356GA SCS08212712GA SCS08112475GA SCS08252806GA SCS09113642GA SCS06440448GA SCS07161066GA SCS07291390GA SCS08102426GA SCS07461994GA AAD05310407GA AAD05510994GA SCS06440396GA SCS06440413GA SCS07171097GA SCS07391633GA SCS07391734GA SCS07391736GA AAD05480911GA SCS08022213GA SCS08022215GA SCS08082354GA SCS08423230GA SCS08423238GA SCS08122515GA SCS09474326GA SCS09474330GA AAD06131473GA AAD05330444GA AAD05360533GA AAD06261880GA AAD06261892GA SCS07231323GA SCS07231328GA SCS07231329GA SCS07231330GA SCS07231333GA SCS07231334GA SCS07231337GA SCS07231347GA SCS07231350GA SCS07231352GA SCS07311419GA SCS07311428GA SCS07371582GA SCS08032240GA SCS08032242GA SCS08112435GA SCS09113639GA SCS07482018GA SCS10144454GA SCS10144459GA SCS10144460GA SCS10144461GA SCS10144465GA SCS10144466GA SCS10144472GA SCS10144475GA SCS10144481GA SCS10144488GA SCS10144495GA SCS10144498GA SCS10144500GA SCS10144531GA SCS10174628GA SCS10174631GA SCS07361531GA SCS07361532GA SCS07361533GA SCS07361536GA SCS07371550GA SCS07371551GA SCS07371552GA SCS07371553GA SCS07391711GA SCS07391725GA SCS07391728GA SCS07161053GA SCS07161054GA SCS07161055GA SCS08413201GA SCS08413205GA SCS08433255GA SCS08433259GA SCS07020734GA AAD05030136GA AAD05030137GP AAD05030146GP AAD05040150GP AAD05040151GP AAD05040153GP AAD05040155GP SCS07040776GA SCS07060836GA SCS07060837GA SCS07090918GA SCS07391642GA SCS07391646GA SCS07391649GA SCS07401778GA SCS09464307GA SCS09474336GA SCS10144516GA SCS06430337GA SCS06430339GA SCS06430348GA SCS07391638GA SCS08503437GA SCS08132552GA SCS09424207GA SCS09474343GA SCS09494345GA SCS09494347GA SCS08433263GA AAD06191643GA AAD06191658GA SCS06390185GA SCS06390189GA SCS08052272GA SCS08112442GA SCS08112465GA SCS08112468GA SCS08112478GA SCS08112483GA SCS08383097GA SCS07482034GA SCS07482080GA SCS08042252GA SCS08042254GA SCS08363019GA SCS08363020GA SCS09474318GA SCS09474337GA SCS08202674GA SCS07231324GA SCS07231331GA SCS07231340GA SCS08393122GA SCS08423242GA SCS09113637GA SCS09113638GA SCS09143685GA SCS09283838GA SCS09333998GA SCS09333999GA SCS09334000GA SCS09334001GA SCS09334002GA SCS09364015GA SCS09384051GA SCS09384087GA SCS09384090GA SCS09384091GA SCS09434216GA SCS09474310GA SCS09474311GA SCS09474331GA SCS09474332GA SCS09474333GA SCS09474334GA SCS09474335GA SCS09474339GA SCS09474342GA SCS09474344GA SCS09494346GA SCS09494348GA SCS09494349GA SCS10144504GA SCS10144509GA SCS10144519GA SCS10144533GA SCS10164595GA AAD05040156GP SCS07391673GA AAD05460888GA SCS07371559GA SCS09454255GA SCS09474315GA AAD05380624GA AAD05380635GA AAD05380637GA AAD05460853GA AAD05460856GA AAD05460874GA AAD05460877GA AAD05460882GA AAD05460884GA AAD05480896GA AAD06322041GA AAD06322047GA SCS07040787GA SCS07391739GA SCS07391742GA SCS07391748GA SCS08242782GA SCS08423239GA SCS08433269GA SCS08433273GA SCS09043582GA SCS09113643GA SCS09113644GA SCS09133648GA SCS08232754GA SCS08232755GA SCS09474323GA SCS07421831GA SCS08503429GA AAD05360553GA SCS08493350GA SCS08493358GA SCS08493361GA SCS08513464GA SCS09333971GA SCS09333979GA SCS09333982GA SCS09133667GA SCS09133668GA SCS09133669GA SCS06480541GA SCS06480548GA SCS06480564GA SCS08232732GA SCS08242774GA SCS08242775GA SCS08242776GA SCS08252797GA SCS07151047GA SCS07151049GA SCS07171094GA SCS07171098GA SCS07191166GA SCS07191167GA SCS07191169GA SCS07191171GA SCS07191177GA SCS07191178GA SCS08072338GA SCS08332949GA SCS08413171GA SCS08232731GA SCS08242757GA SCS08242759GA SCS08242760GA AAD06031134GA SCS08122503GA SCS08122508GA SCS08122509GA SCS08122514GA SCS08122516GA SCS10144458GA SCS06460468GA SCS06480506GA SCS08423222GA SCS07080883GA SCS07080897GA SCS07080903GA SCS07371565GA SCS07371566GA SCS07371597GA SCS09474321GA SCS09474324GA SCS09474329GA SCS09464295GA SCS09474341GA SCS07171093GA SCS07171095GA SCS07171103GA SCS07171105GA SCS08022209GA SCS08022212GA SCS08022214GA AAD05350491GA SCS08122499GA SCS08122500GA SCS08192664GA SCS08202665GA SCS08012189GA SCS08012192GA SCS08022200GA SCS08022203GA SCS08022207GA SCS08022208GA SCS08022210GA SCS08022211GA SCS08102414GA SCS08102424GA SCS08142576GA SCS08142578GA AAD06131474GA SCS08383105GA SCS08383107GA SCS09153702GA SCS09153704GA SCS09193742GA SCS09193743GA SCS09193744GA SCS09193745GA SCS09193746GA SCS09193747GA SCS09193748GA SCS09193752GA SCS09203762GA SCS09203763GA SCS09203767GA SCS09203768GA SCS08212705GA SCS08212709GA SCS08222716GA SCS08312935GA SCS08312940GA SCS08342956GA SCS08252814GA SCS08393131GA SCS08393133GA SCS08393139GA SCS08393143GA SCS08393147GA SCS08393148GA SCS08393160GA SCS08393162GA SCS08413169GA SCS08413172GA SCS10144490GA SCS10144492GA SCS10144507GA SCS10154550GA AAD06352093GA AAD06352095GA SCS06500631GA SCS07030739GA SCS07030740GA SCS07030742GA SCS07030745GA SCS07030747GA SCS07030752GA SCS07030764GA SCS09454258GA SCS09454260GA SCS08082359GA SCS08092374GA SCS08092375GA SCS08092384GA SCS08092385GA SCS08102407GA SCS08102411GA SCS09143676GA SCS09143677GA AAD06362139GA SCS07090924GA SCS07441931GA SCS08072319GA SCS08072340GA SCS09133659GA SCS09524418GA SCS09524419GA AAD05330449GA SCS07060817GA SCS07070865GA SCS07311418GA SCS07311422GA SCS07361505GA SCS08062301GA SCS08062302GA SCS08503442GA SCS08513451GA SCS08513456GA SCS08513458GA SCS08513461GA SCS08513462GA SCS09384049GA SCS09384050GA SCS09434230GA SCS09464286GA SCS09464308GA SCS10144545GA SCS10154569GA SCS10154572GA SCS06430353GA SCS06440412GA SCS07151037GA SCS07221313GA SCS07221320GA SCS07311427GA SCS08032224GA AAD05470893GA AAD05500949GA AAD05500950GA AAD05500951GA AAD05500961GA AAD06081257GA AAD06091267GA AAD06091271GA AAD06091279GA AAD06171518GA AAD06171519GA AAD06171525GA AAD06191649GA SCS06440376GA SCS07080888GA SCS07090909GA SCS07090917GA SCS07201211GA SCS07291383GA SCS07411783GA SCS07411784GA SCS07462003GA SCS08052264GA SCS08052270GA SCS08072329GA SCS08092378GA SCS08112461GA SCS08142587GA SCS08292873GA SCS08493366GA SCS09333956GA SCS09504354GA SCS09504357GA SCS10154564GA SCS10154575GA SCS10164588GA SCS10164591GA SCS10164611GA
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter dated September 17, 2010.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer rolls-over, the Transport Pro will display an EC1 message. If the Transport Pro is continued to be used without clearing the EC1 message, after additional 19 days of service time, loss of communication between the Transport Pro and a connected CARESCAPE Patient Data Module (PDM) will occur. This results in the loss of the displayed parameter information (e.g. waveforms, numerical data, and alarms). This condition affects all released versions of software.
VOLUME OF PRODUCT IN COMMERCE
3,256 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607. Recall # Z-0366-2011
CODE
Lot 0083198 Exp 03/31/2011
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by letter dated May 2010. Firm initiated recall is complete.
REASON
The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
VOLUME OF PRODUCT IN COMMERCE
2,650 pouches
DISTRIBUTION
CA, MD, NJ, PA. WI
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PRODUCT
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media. Recall # Z-0367-2011
CODE
Lot Numbers 96501 exp 11/2014 and 96502 exp 11/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medrad, Inc., Warrendale, PA, by letter dated May 17, 2010.
Manufacturer: Medrad, Inc., Indianola, PA. Firm initiated recall is complete. 
REASON
Some kits have a hole in the packaging which could compromise the sterility of the components.
VOLUME OF PRODUCT IN COMMERCE
39,448 units
DISTRIBUTION
Nationwide, Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore
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PRODUCT
Millar Disposable Angiographic Catheter (Left Heart), Catalog-Models: SPC-454D, SPC-454E, SPC-454F, SPC-464D. Product Code/Part No.: 800-4219-1, 800-4219-2, 800-4219-3, 802-1029X. Recall # Z-0401-2011
CODE
Lot Numbers: L057674, L064963, L057687, L062222, L061409, L057687, L065039, L058763.
S/N: 407126, 407128, 493801, 391962, 466255, 466256, 435426, 391965, 391968, 493756, 425284, 425285
RECALLING FIRM/MANUFACTURER
Millar Instruments, Inc., Houston, TX, by letter on October 14, 2010. Firm initiated recall is ongoing.
REASON
The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
MA, OH, PA, and D.C., and Canada and Germany
___________________________________
PRODUCT
1) Vortex VX Port, Catalogue Number: P530K, P5355K, P5405K, P4455K, P12105K, P12155K, P12305K and P12355. Recall # Z-0402-2011;

2) Vortex TR, Catalogue Number: SPDX-14-1, SPAX-16-1, SSDX-10-1, SSAX-14-1, SSAX-16-1, SSDX-16-1, PSAX-10-1, PSDX-10-1, SPDX-16-1 and SSDX-14-1. Recall # Z-0403-2011;

3) Vortex LP, Catalogue Number: LVTX5557, SVTX7515, LVTX5015, LVTX5213, LVTX71513, LVTX7015, LVTX7013, LVTX5513, LVTX5057, LVTX5013 and LVTX5555.  Recall # Z-0404-2011;

4) LifePort, Catalogue Number: LPS5057, LPS5555, LPS5513, LPS5013, LPS7015, LPS7013, LPS7523, LPS7515, LPS7513, LPS7255 and LPS7113. Recall # Z-0405-2011;

5) Triumph-1. Catalogue Number: PSA-10-1, PSD-10, SPD-16-1, SPD-14-1, SSA-14-1, SSD-16-1, SSD-14-1, SSD-10-1, and SSA-16-1. Recall # Z-0406-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Manchester, GA, by letter dated September 27, 2010. Firm initiated recall is ongoing.
REASON
Labeling Error; the labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set
VOLUME OF PRODUCT IN COMMERCE
6,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011
CODE
Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 15, 2010.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.
REASON
Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Rascal LiteWay 214; 510 K - K002616; Device Listing #E394292; LW214, EMC Part #43062400, EMC Part #43062500 LW3 Plus, EMC Part #43062600 LW3x6, EMC Part #43062800. Recall # Z-0415-2011;

2) Rascal LiteWay 224; 510 K - K002616; Device Listing #E394292; LW224, EMC Part #43062300, EMC Part #43062700. Recall # Z-0416-2011;

3) Rascal UltraLite 370B; 510 K - K002616; Device Listing #E394292; UL370B, EMC Part #42021011, EMC Part #42021012. Recall # Z-0417-2011
CODE
No expiration dates
RECALLING FIRM/MANUFACTURER
Electric Mobility Corp., Sewell, NJ, by letters dated October 7, 2010 and November 11, 2010.
Manufacturer: Giant Manufacturing Co Ltd., Taichung Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
VOLUME OF PRODUCT IN COMMERCE
146 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Medtronic Dual Chamber Temporary Pacemaker, model 5388. Recall # Z-0430-2011
CODE

Serial numbers: PEG026278, PFG001362P, PFG001406P, PFG001755P, PFG001906P, PFG001918P, PFG002648P, PFG002911P, PFG002929P, PFG003371P, PFG003923P, PFG003932P, PFG003933P, PFG004462P, PFG005391P, PFG007169P, PFG008759P, PFG015326P, PFG01534P, PFG015449P, PFG017606P, PFG018062P, PFG018161P, PFG018176P, PFG018429P, PFG018475P, PFG020770P, PFG021284P, PFG021309P, PFG022541P, PFG022740P, PFG022864P, PFG022902P, PFG023043P, PFG023107P, PFG023108P, PFG023473P, PFG023518P, PFG023608P, PFG023933P, PFG023987P, PFG024002P, PFG025347P, PFG025736P, PFG025746P, PFG026378P, PFG028007P, PFG028350P, PFG028755P, PFG028986P, PFG029169P, PFG029173P, PFG029174P, PFG029175P, PFG029176P, PFG029177P, PFG029237P, PFG029603P, PFG029604P, PFG029808P, PFG029967P, PFG030425P, PFG030707P, PFG031194P, PFG031195P, PFG031197P, PFG031386P, PFG031538P, PFG031539P, PFG031540P, PFG031543P, PFG031789P, PFG031838P, PFG032089P, PFG032121P, PFG033136P, PFG033229P, PFG033266P, PFG033323P, PFG033537P, PFG033703P, PFG033791P, PFG034239P, PFG034732P thru PFG034769P, PFG034770P, PFG034771P, PFG034772P, PFG050100P thru PFG050137P, PFG050139P, PFG050140P, PFG050141P, PFG050142P, PFG050144P, PFG050146P thru PFG050162P, PFG050165P, PFG050166P, PFG050167P, PFG050168P, PFG050169P, PFG050170P, PFG050171P, PFG050172P, PFG050173P, PFG050175P, PFG050176P, PFG050177P, PFG050178P, PFG050179P, PFG050180P, PFG050182P, PFG050183P, PFG050184P, PFG050185P, PFG050186P, PFG050187P, PFG050188P, PFG050189P, PFG050191P thru PFG050243P, PFG050246P thru PFG050263P, PFG050266P, PFG050267P, PFG050269P, PFG050270P, PFG050271P, PFG050273P, PFG050274P, PFG050275P, PFG050277P, PFG050278P, PFG050279P, PFG050280P, PFG050281P, PFG050282P, PFG050283P, PFG050284P, PFG050285P, PFG050287P, PFG050288P, PFG050289P, PFG050290P, PFG050291P, PFG050292P, PFG050293P, PFG050294P, PFG050295P, PFG050296P, PFG050297P, PFG050298P, PFG050299P, PFG050300P, PFG050302P thru PFG050323P, PFG050325P thru PFG050367P, PFG050369P, PFG050370P, PFG050371P, PFG050372P, PFG050373P, PFG050374P, PFG050375P, PFG050376P, PFG050378P thru PFG050391P, PFG050393P, PFG050395P, PFG050397P, PFG050398P, PFG050399P, PFG050401P thru PFG050466P, PFG050468P thru PFG050524P, PFG050526P, PFG050528P, PFG050529P, PFG050530P, PFG050532P, PFG050533P, PFG050535P, PFG050538P thru PFG050555P, PFG050557P, PFG050558P, PFG050560P thru PFG050577P, PFG050579P, PFG050580P, PFG050582P, PFG050586P, PFG050587P, PFG050588P, PFG050589P, PFG050590P, PFG050592P, PFG050593P, PFG050594P, PFG050598P, PFG050599P, PFG050600P, PFG050601P, PFG050602P, PFG050603P, PFG050604P, PFG050605P, PFG050606P, PFG050607P, PFG050608P, PFG050609P, PFG050610P, PFG050611P, PFG050613P, PFG050614P, PFG050615P, PFG050617P thru PFG050653P, PFG050655P thru PFG050682P, PFG050684P, PFG050685P, PFG050686P, PFG050687P, PFG050688P, PFG050690P, PFG050693P, PFG050695P thru PFG050710P, PFG050712P, PFG050716P, PFG050717P, PFG050720P, PFG050721P, PFG050724P thru PFG050741P, PFG050746P, PFG050747P, PFG050748P, PFG050749P, PFG050750P, PFG050751P, PFG050753P thru PFG050763P, PFG050765P, PFG050767P, PFG050769P, PFG050770P, PFG050772P, PFG050775P, PFG050776P, PFG050777P, PFG050780P thru PFG050797P, PFG050800P thru PFG050887P, PFG050890P, PFG050891P, PFG050892P, PFG050893P, PFG050895P thru PFG050917P, PFG050919P thru PFG050931P, PFG050933P, PFG050935P, PFG050936P, PFG050937P, PFG050938P, PFG050940P, PFG050941P, PFG050942P, PFG050943P, PFG050945P thru PFG050963P, PFG050965P thru PFG050997P, PFG050999P, PFG051000P, PFG051001P, PFG051002P, PFG051003P, PFG051004P, PFG051005P, PFG051006P, PFG051007P, PFG051008P, PFG051009P, PFG051010P, PFG051012P thru PFG051043P, PFG051045P, PFG051046P, PFG051050P, PFG051051P, PFG051052P, PFG051053P, PFG051054P, PFG051055P, PFG051056P, PFG051057P, PFG051058P, PFG051060P thru PFG051083P, PFG051085P thru PFG051130P, PFG051133P thru PFG051144P, PFG051146P, PFG051148P thru PFG051178P, PFG051181P thru PFG051235P, PFG051237P thru PFG051288P, PFG051290P thru PFG051374P, PFG051376P thru PFG051445P, PFG051447P thru PFG051456P, PFG051458P thru PFG051475P, PFG051477P thru PFG051510P, PFG051512P thru PFG051532P, PFG051535P thru PFG051567P, PFG051569P, PFG051571P, PFG051573P thru PFG051611P, PFG051613P thru PFG051647P, PFG051649P, PFG051650P, PFG051651P, PFG051652P, PFG051653P, PFG051654P, PFG051655P, PFG051657P thru PFG051675P, PFG051677P thru PFG051691P, PFG051700P thru PFG051713P, PFG051715P, PFG051716P, PFG051717P, PFG051719P, PFG051721P thru PFG051787P, PFG051789P, PFG051791P, PFG051793P, PFG051795P, PFG051797P thru PFG051813P, PFG051815P, PFG051818P thru PFG051872P, PFG051874P thru PFG051906P, PFG051908P, PFG051909P, PFG051910P, PFG051911P, PFG051912P, PFG051915P, PFG051916P, PFG051917P, PFG051918P, PFG051919P, PFG051920P, PFG051921P, PFG051922P, PFG051923P, PFG051924P, PFG051925P, PFG051926P, PFG051928P, PFG051929P, PFG051930P, PFG051932P thru PFG051950P, PFG051952P, PFG051953P, PFG051958P, PFG051961P, PFG051962P, PFG051963P, PFG051964P, PFG051966P thru PFG052051P, PFG052054P, PFG052055P, PFG052056P, PFG052057P, PFG052058P, PFG052059P, PFG052061P, PFG052062P, PFG052063P, PFG052064P, PFG052065P, PFG052066P, PFG052067P, PFG052068P, PFG052069P, PFG052070P, PFG052071P, PFG052072P, PFG052073P, PFG052074P, PFG052076P thru PFG052171P, PFG052173P, PFG052175P thru PFG052203P, PFG052205P thru PFG052229P, PFG052232P, PFG052233P, PFG052235P, PFG052236P, PFG052237P, PFG052238P, PFG052241P, PFG052242P, PFG052243P, PFG052244P, PFG052245P, PFG052246P, PFG052247P, PFG052248P, PFG052249P, PFG052250P, PFG052251P, PFG052252P, PFG052254P thru PFG052273P, PFG052275P thru PFG052381P, PFG052383P, PFG052384P, PFG052385P, PFG052386P, PFG052387P, PFG052388P, PFG052389P, PFG052390P, PFG052392P, PFG052393P, PFG052394P, PFG052395P, PFG052396P, PFG052397P, PFG052398P, PFG052402P thru PFG052415P, PFG052417P, PFG052418P, PFG052419P, PFG052421P, PFG052422P, PFG052423P, PFG052424P, PFG052425P, PFG052426P, PFG052427P, PFG052428P, PFG052430P, PFG052431P, PFG052432P, PFG052433P, PFG052434P, PFG052435P, PFG052437P thru PFG052506P, PFG052508P, PFG052509P, PFG052511P thru PFG052599P, PFG052601P, PFG052603P, PFG052604P, PFG052605P, PFG052606P, PFG052607P, PFG052608P, PFG052609P, PFG052611P, PFG052612P, PFG052613P, PFG052614P, PFG052615P, PFG052616P, PFG052617P, PFG052618P, PFG052619P, PFG052620P, PFG052621P, PFG052622P, PFG052623P, PFG052624P, PFG052626P, PFG052627P, PFG052628P, PFG052629P, PFG052630P, PFG052631P, PFG052632P, PFG052634P, PFG052635P, PFG052636P, PFG052637P, PFG052640P thru PFG052684P, PFG052686P, PFG052687P, PFG052689P thru PFG052736P, PFG052739P, PFG052740P, PFG052741P, PFG052742P, PFG052744P thru PFG052770P, PFG052772P thru PFG052833P, PFG052835P thru PFG052855P, PFG052859P, PFG052860P, PFG052862P, PFG052864P, PFG052865P thru PFG052904P, PFG052907P thru PFG052952P, PFG052954P thru PFG052969P, PFG052971P thru PFG053006P, PFG053008P, PFG053009P, PFG053010P, PFG053011P, PFG053012P, PFG053013P, PFG053014P, PFG053017P thru PFG053083P, PFG053086P, PFG053087P, PFG053089P, PFG053090P, PFG053091P, PFG053092P, PFG053093P, PFG053094P, PFG053095P, PFG053096P, PFG053097P, PFG053098P, PFG053099P, PFG053100P, PFG053101P, PFG053102P, PFG053103P, PFG053104P, PFG053105P, PFG053106P, PFG053107P, PFG053108P, PFG053109P, PFG053111P thru PFG053133P, PFG053135P, PFG053136P, PFG053137P, PFG053138P, PFG053139P, PFG053140P, PFG053141P, PFG053142P, PFG053143P, PFG053144P, PFG053145P, PFG053146P, PFG053148P, PFG053149P, PFG053150P, PFG053151P, PFG053152P, PFG053153P, PFG053155P thru PFG053175P, PFG053177P, PFG053179P thru PFG053306P, PFG053308P thru PFG053326P, PFG053328P, PFG053329P, PFG053330P, PFG053331P, PFG053332P, PFG053333P, PFG053335P thru PFG053357P, PFG053362P thru PFG053392P, PFG053394P, PFG053395P, PFG053397P, PFG053398P, PFG053399P, PFG053401P, PFG053402P, PFG053403P, PFG053404P, PFG053406P, PFG053407P, PFG053408P, PFG053409P, PFG053410P, PFG053411P, PFG053413P thru PFG053448P, PFG053450P, PFG053451P, PFG053452P, PFG053453P, PFG053454P, PFG053455P, PFG053456P, PFG053457P, PFG053458P, PFG053459P, PFG053460P, PFG053461P, PFG053462P, PFG053464P thru PFG053485P, PFG053487P, PFG053488P, PFG053489P, PFG053490P, PFG053492P thru PFG053538P, PFG053540P thru PFG053570P, PFG053572P thru PFG053597P, PFG053600P, PFG053602P, PFG053603P, PFG053604P, PFG053605P, PFG053606P, PFG053607P, PFG053608P, PFG053609P, PFG053610P, PFG053612P, PFG053613P, PFG053614P, PFG053617P thru PFG053697P, PFG100003R, PFG100004R, PFG100005R, PFG100006R, PFG100008R, PFG100009R, PFG100011R, PFG100013R, PFG100014R, PFG100015R, PFG100016R, PFG100018R, PFG100020R, PFG100021R, PFG100022R, PFG100023R, PFG100024R, PFG100025R, PFG100027R, PFG100030R, PFG100031R, PFG100032R, PFG100033R, PFG100034R, PFG100035R, PFG100036R, PFG100037R, PFG100038R, PFG100039R, PFG100041R, PFG100043R, PFG100044R, PFG100045R, PFG100046R, PFG100047R, PFG100048R, PFG100049R, PFG100050R, PFG100051R, PFG100052R, PFG100053R, PFG100054R, PFG100056R, PFG100057R, PFG100058R, PFG100059R, PFG100060R, PFG100061R, PFG100062R, PFG100064R, PFG100066R, PFG100067R, PFG100068R, PFG100069R, PFG100070R, PFG100071R, PFG100072R, PFG100073R, PFG100075R, PFG100077R, PFG100078R, PFG100079R, PFG100080R, PFG100081R, PFG100082R, PFG100083R, PFG100084R, PFG100085R, PFG100087R, PFG100089R, PFG100091R, PFG100092R, PFG100093R, PFG100094R, PFG100097R, PFG100098R, PFG100099R, PFG100100R, PFG100101R, PFG100102R, PFG100103R, PFG100104R, PFG100106R, PFG100108R, PFG100109R, PFG100110R, PFG100111R, PFG100112R, PFG100113R, PFG100114R, PFG100115R, PFG100116R, PFG100117R, PFG100118R, PFG100119R, PFG100120R, PFG100122R, PFG100123R, PFG100124R, PFG100125R, PFG100127R, PFG100128R, PFG100130R, PFG100132R, PFG100133R, PFG100135R, PFG100136R, PFG100137R, PFG100138R, PFG100139R, PFG100140R, PFG100141R, PFG100142R, PFG100144R thru PFG100259R, PFG100261R, PFG100262R, PFG100263R, PFG100265R, PFG100266R, PFG100268R thru PFG100327R, PFG100329R, PFG100330R, PFG100331R, PFG100332R, PFG100334R thru PFG100367R, PFG100369R, PFG100370R, PFG100371R, PFG100372R, PFG100373R, PFG100374R, PFG100375R, PFG100377R, PFG100378R, PFG100379R, PFG100380R, PFG100381R, PFG100382R, PFG100384R thru PFG100410R, PFG100412R, PFG100413R, PFG100414R, PFG100415R, PFG100416R, PFG100417R, PFG100418R, PFG100421R, PFG100422R, PFG100424R, PFG100425R, PFG100426R, PFG100428R, PFG100429R, PFG100430R, PFG100432R, PFG100433R, PFG100434R, PFG100435R, PFG100436R, PFG100437R, PFG100438R, PFG100439R, PFG100440R, PFG100441R, PFG100442R, PFG100444R thru PFG100490R, PFG100492R thru PFG100511R, PFG100513R, PFG100514R, PFG100515R, PFG100516R, PFG100517R, PFG100518R, PFG100519R, PFG100520R, PFG100521R, PFG100522R, PFG100523R, PFG100524R, PFG100525R, PFG100526R, PFG100527R, PFG100529R, PFG100531R thru PFG100588R, PFG100590R thru PFG100625R, PFG100627R thru PFG100676R, PFG100678R, PFG100679R, PFG100680R thru PFG100807R, PFG100809R, PFG100810R, PFG100811R, PFG100812R, PFG100813R, PFG100814R, PFG100816R, PFG100817R, PFG100818R, PFG100819R, PFG100820R, PFG100821R, PFG100823R thru PFG100844R, PFG100847R thru PFG100871R, PFG100873R thru PFG100890R, PFG100892R, PFG100893R, PFG100895R, PFG100896R, PFG100897R, PFG100898R, PFG100899R, PFG100900R, PFG100901R thru PFG101019R, PFG101022R, PFG101024R thru PFG101058R, PFG101061R, PFG101062R, PFG101063R, PFG101064R, PFG101065R, PFG101066R, PFG101067R, PFG101068R, PFG101069R, PFG101070R, PFG101071R, PFG101072R, PFG101074R, PFG101076R, PFG101077R, PFG101080R, PFG101081R, PFG101082R, PFG101083R, PFG101084R, PFG101085R, PFG101086R, PFG101087R, PFG101088R, PFG101089R, PFG101090R, PFG101091R, PFG101093R, PFG101095R, PFG101096R, PFG101098R, PFG101101R thru PFG101182R, PFG101184R, PFG101185R, PFG101186R, PFG101187R, PFG101188R, PFG101189R, PFG101190R, PFG101191R, PFG101192R, PFG101193R, PFG101194R, PFG101195R, PFG101196R, PFG101197R, PFG101198R, PFG101199R, PFG101201R, PFG101202R, PFG101203R, PFG101204R, PFG101205R, PFG101207R thru PFG101241R, PFG101243R, PFG101245R thru PFG101292R, PFG101294R thru PFG101305R, PFG101307R, PFG101308R, PFG101309R, PFG101310R, PFG101311R, PFG101312R, PFG101313R, PFG101314R, PFG101315R, PFG101316R, PFG101319R, PFG101320R, PFG101323R, PFG101324R, PFG101325R, PFG101326R, PFG101327R, PFG101328R, PFG101329R, PFG101330R, PFG101331R, PFG101332R, PFG101333R, PFG101335R, PFG101336R, PFG101337R, PFG101338R, PFG101339R, PFG101341R, PFG101342R, PFG101343R, PFG101345R, PFG101346R, PFG101347R, PFG101348R, PFG101349R, PFG101350R, PFG101351R, PFG101353R, PFG101354R, PFG101355R, PFG101356R, PFG101357R, PFG101358R, PFG101360R, PFG101361R, PFG101362R, PFG101363R, PFG101364R, PFG101365R, PFG101366R, PFG101367R, PFG101368R, PFG101369R, PFG101370R, PFG101372R, PFG101374R thru PFG101393R, PFG101395R thru PFG101417R, PFG101420R thru PFG101435R, PFG101437R, PFG101438R, PFG101439R, PFG101440R, PFG101441R, PFG101442R, PFG101443R, PFG101444R, PFG101445R, PFG101447R thru PFG101535R, PFG101538R thru PFG101592R, PFG101594R, PFG101596R, PFG101598R, PFG101599R, PFG101601R, PFG101602R, PFG101603R, PFG101605R thru PFG101621R, PFG101623R, PFG101624R, PFG101626R, PFG101627R, PFG101629R, PFG101631R, PFG101632R, PFG101634R thru PFG101652R, PFG101654R, PFG101655R, PFG101656R, PFG101657R, PFG101658R, PFG101660R, PFG101661R, PFG101662R, PFG101663R, PFG101664R, PFG101665R, PFG101666R, PFG101667R, PFG101668R, PFG101669R, PFG101670R, PFG101672R, PFG101673R, PFG101674R, PFG101675R, PFG101676R, PFG101677R, PFG101678R, PFG101679R, PFG101680R, PFG101681R, PFG101682R, PFG101684R, PFG101685R, PFG101686R, PFG101687R, PFG101688R, PFG101689R, PFG101690R, PFG101691R, PFG101692R, PFG101693R, PFG101694R, PFG101696R thru PFG101719R, PFG101722R, PFG101723R, PFG101724R, PFG101725R, PFG101728R thru PFG101753R, PFG101755R, PFG101757R thru PFG101774R, PFG101776R thru PFG101864R, PFG101868R, PFG101869R, PFG101870R, PFG101871R, PFG101872R, PFG101873R, PFG101874R, PFG101875R, PFG101877R, PFG101878R, PFG101879R, PFG101880R, PFG101881R, PFG101882R, PFG101883R, PFG101884R, PFG101885R, PFG101886R, PFG101887R, PFG101888R, PFG101889R, PFG101890R, PFG101891R, PFG101893R, PFG101894R, PFG101895R, PFG101898R thru PFG101956R, PFG101958R thru PFG102033R, PFG102035R, PFG102036R, PFG102037R, PFG102038R, PFG102039R, PFG102040R, PFG102041R, PFG102043R, PFG102045R thru PFG102108R, PFG102110R, PFG102111R, PFG102112R, PFG102113R, PFG102114R, PFG102115R, PFG102176R thru PFG102232R, PFG102236R thru PFG102252R, PFG102257R, PFG102258R, PFG102259R, PFG102260R, PFG102261R, PFG102262R, PFG102272R thru PFG102291R, PFG102293R thru PFG102302R, PFG102304R, PFG102305R, PFG102306R, PFG102307R, PFG102308R, PFG102309R, PFG102310R, PFG102311R, PFG102312R, PFG102376R, PFG102378R, PFG102379R, PFG102380R, PFG102382R, PFG102383R, PFG102384R, PFG102385R, EXPANDED: PFG001040P, PFG001186P, PFG001187P, PFG001229P, PFG001421P, PFG001697P, PFG001793P, PFG001829P, PFG001831P, PFG001841P, PFG001871P, PFG001874P, PFG001877P, PFG001885P, PFG001892P, PFG001893P, PFG001913P, PFG001915P, PFG001926P, PFG001946P, PFG001949P, PFG001950P, PFG001974P, PFG001978P, PFG001988P, PFG001989P, PFG001998P, PFG002001P, PFG002005P, PFG002025P, PFG002035P, PFG002037P, PFG002065P, PFG002080P, PFG002086P, PFG002100P, PFG002107P, PFG002108P, PFG002118P, PFG002119P, PFG002130P, PFG002136P, PFG002158P, PFG002182P, PFG002192P, PFG002227P, PFG002240P, PFG002255P, PFG002256P, PFG002265P, PFG002289P, PFG002309P, PFG002310P, PFG002311P, PFG002345P, PFG002369P, PFG002409P, PFG002411P, PFG002492P, PFG002536P, PFG002561P, PFG002592P, PFG002602P, PFG002638P, PFG002656P, PFG002659P, PFG002677P, PFG002697P, PFG002725P, PFG002732P, PFG002757P, PFG002765P, PFG002793P, PFG002801P, PFG002841P, PFG002842P, PFG002891P, PFG003042P, PFG003086P, PFG003134P, PFG003152P, PFG003167P, PFG003187P, PFG003214P, PFG003260P, PFG003322P, PFG003324P, PFG003402P, PFG003441P, PFG003443P, PFG003447P, PFG003451P, PFG003468P, PFG003485P, PFG003508P, PFG003542P, PFG003560P, PFG003567P, PFG003584P, PFG003585P, PFG003687P, PFG003707P, PFG003749P, PFG003750P, PFG003751P, PFG003782P, PFG003794P, PFG003915P, PFG003921P, PFG003944P, PFG003945P, PFG003959P, PFG003984P, PFG004016P, PFG004034P, PFG004038P, PFG004042P, PFG004063P, PFG004093P, PFG004101P, PFG004103P, PFG004113P, PFG004158P, PFG004174P, PFG004205P, PFG004206P, PFG004223P, PFG004257P, PFG004265P, PFG004266P, PFG004270P, PFG004288P, PFG004289P, PFG004295P, PFG004327P, PFG004331P, PFG004467P, PFG004499P, PFG004500P, PFG004501P, PFG004502P, PFG004535P, PFG004563P, PFG004595P, PFG004604P, PFG004622P, PFG004660P, PFG004668P, PFG004670P, PFG004685P, PFG004701P, PFG004708P, PFG004719P, PFG004738P, PFG004741P, PFG004754P, PFG004873P, PFG004895P, PFG004908P, PFG005058P, PFG005071P, PFG005109P, PFG005122P, PFG005126P, PFG005128P, PFG005130P, PFG005133P, PFG005143P, PFG005147P, PFG005158P, PFG005170P, PFG005180P, PFG005190P, PFG005206P, PFG005229P, PFG005266P, PFG005268P, PFG005278P, PFG005286P, PFG005429P, PFG005436P, PFG005458P, PFG005467P, PFG005478P, PFG005492P, PFG005499P, PFG005503P, PFG005509P, PFG005517P, PFG005520P, PFG005526P, PFG005694P, PFG005698P, PFG005749P, PFG005782P, PFG005870P, PFG005889P, PFG005891P, PFG005896P, PFG005916P, PFG005921P, PFG005927P, PFG005928P, PFG005932P, PFG005936P, PFG005939P, PFG005959P, PFG005960P, PFG005972P, PFG005973P, PFG006019P, PFG006065P, PFG006089P, PFG006098P, PFG006161P, PFG006257P, PFG006274P, PFG006278P, PFG006280P, PFG006285P, PFG006293P, PFG006300P, PFG006301P, PFG006302P, PFG006304P, PFG006308P, PFG006439P, PFG006504P, PFG006514P, PFG006547P, PFG006549P, PFG006572P, PFG006662P, PFG006664P, PFG006665P, PFG006695P, PFG006698P, PFG006719P, PFG006730P, PFG006760P, PFG006808P, PFG006838P, PFG006865P, PFG006879P, PFG006883P, PFG006964P, PFG006995P, PFG007094P, PFG007107P, PFG007121P, PFG007209P, PFG007227P, PFG007266P, PFG007278P, PFG007328P, PFG007349P, PFG007376P, PFG007407P, PFG007446P, PFG007450P, PFG007479P, PFG007490P, PFG007495P, PFG007506P, PFG007538P, PFG007573P, PFG007596P, PFG007627P, PFG007648P, PFG007653P, PFG007654P, PFG007698P, PFG007711P, PFG007758P, PFG007783P, PFG007858P, PFG007926P, PFG007933P, PFG007955P, PFG007967P, PFG007972P, PFG008024P, PFG008225P, PFG008321P, PFG008418P, PFG008435P, PFG008442P, PFG008599P, PFG008611P, PFG008726P, PFG008743P, PFG008808P, PFG008838P, PFG009004P, PFG009007P, PFG009057P, PFG009159P, PFG009175P, PFG009245P, PFG009280P, PFG009323P, PFG009335P, PFG009358P, PFG009417P, PFG009461P, PFG009476P, PFG009489P, PFG009545P, PFG009556P, PFG009565P, PFG009718P, PFG009774P, PFG009806P, PFG009814P, PFG009853P, PFG009859P, PFG009875P, PFG009926P, PFG009931P, PFG009935P, PFG009956P, PFG009969P, PFG010017P, PFG010027P, PFG010041P, PFG010098P, PFG010128P, PFG010146P, PFG010168P, PFG010196P, PFG010320P, PFG010430P, PFG010431P, PFG010437P, PFG010439P, PFG010696P, PFG010702P, PFG010703P, PFG010731P, PFG010879P, PFG010920P, PFG010921P, PFG010924P, PFG010936P, PFG010964P, PFG010974P, PFG010975P, PFG010977P, PFG011020P, PFG011239P,

PFG011294P, PFG011300P, PFG011374P, PFG011438P, PFG011667P, PFG011727P, PFG011781P, PFG011968P, PFG012096P, PFG012288P, PFG012297P, PFG012309P, PFG012336P, PFG012405P, PFG012406P, PFG012465P, PFG012492P, PFG012502P, PFG012701P, PFG012728P, PFG012798P, PFG012809P, PFG012996P, PFG013028P, PFG013069P, PFG013071P, PFG013139P, PFG013193P, PFG013219P, PFG013275P, PFG013408P, PFG013454P, PFG013578P, PFG013845P, PFG013846P, PFG013960P, PFG013965P, PFG013975P, PFG014129P, PFG014182P, PFG014203P, PFG014331P, PFG014334P, PFG014405P, PFG014530P, PFG014546P, PFG014611P, PFG014891P, PFG014906P, PFG014964P, PFG014983P, PFG015068P, PFG015069P, PFG015072P, PFG015076P, PFG015140P, PFG015168P, PFG015272P, PFG015274P, PFG015397P, PFG015714P, PFG015729P, PFG015785P, PFG015889P, PFG015941P, PFG016000P, PFG016069P, PFG016242P, PFG016408P, PFG016419P, PFG016467P, PFG016655P, PFG016717P, PFG016816P, PFG017040P, PFG017042P, PFG017096P, PFG017126P, PFG017133P, PFG017222P, PFG017255P, PFG017266P, PFG017279P, PFG017304P, PFG017380P, PFG017481P, PFG017551P, PFG017583P, PFG017678P, PFG017692P, PFG017730P, PFG017837P, PFG017838P, PFG017841P, PFG018097P, PFG018101P, PFG018104P, PFG018106P, PFG018115P, PFG018118P, PFG018119P, PFG018120P, PFG018124P, PFG018268P, PFG018316P, PFG018324P, PFG018400P, PFG018736P, PFG018774P, PFG018800P, PFG018835P, PFG018887P, PFG019126P, PFG019179P, PFG019180P, PFG019319P, PFG019404P, PFG019429P, PFG019549P, PFG019552P, PFG019592P, PFG019698P, PFG019700P, PFG019800P, PFG019826P, PFG019846P, PFG020098P, PFG020288P, PFG020317P, PFG020347P, PFG020362P, PFG020419P, PFG020421P, PFG020428P, PFG020647P, PFG020682P, PFG020698P, PFG020714P, PFG020873P, PFG021028P, PFG021128P, PFG021131P, PFG021151P, PFG021183P, PFG021224P, PFG021247P, PFG021362P, PFG021424P, PFG021425P, PFG021471P, PFG021515P, PFG021557P, PFG021644P, PFG021689P, PFG021796P, PFG022037P, PFG022079P, PFG022349P, PFG022352P, PFG022381P, PFG022383P, PFG022446P, PFG022453P, PFG022521P, PFG022554P, PFG022608P, PFG022610P, PFG022611P, PFG022613P, PFG022784P, PFG022813P, PFG022826P, PFG022887P, PFG022972P, PFG023304P, PFG023424P, PFG023465P, PFG023580P, PFG023651P, PFG023714P, PFG023941P, PFG025034P, PFG025107P, PFG025221P, PFG025223P, PFG025297P, PFG025435P, PFG025440P, PFG025444P, PFG025447P, PFG025449P, PFG025631P, PFG025743P, PFG025747P, PFG025867P, PFG025868P, PFG025889P, PFG025899P, PFG026047P, PFG026058P, PFG026114P, PFG026138P, PFG026188P, PFG026196P, PFG026443P, PFG026700P, PFG026740P, PFG026794P, PFG026800P, PFG026804P, PFG026808P, PFG026813P, PFG026815P, PFG026836P, PFG026889P, PFG026995P, PFG027115P, PFG027151P, PFG027463P, PFG027734P, PFG027974P, PFG028116P, PFG028125P, PFG028170P, PFG028176P, PFG028211P, PFG028406P, PFG028429P, PFG028447P, PFG028451P, PFG028452P, PFG028807P, PFG029022P, PFG029035P, PFG029047P, PFG029285P, PFG029330P, PFG029388P, PFG029404P, PFG029431P, PFG029724P, PFG029794P, PFG030113P, PFG030226P, PFG030233P, PFG030532P, PFG030614P, PFG030630P, PFG030648P, PFG031015P, PFG031028P, PFG031054P, PFG031086P, PFG031914P, PFG031920P, PFG031921P, PFG031955P, PFG032041P, PFG032043P, PFG032055P, PFG032471P, PFG032555P, PFG032558P, PFG032635P, PFG032693P, PFG032776P, PFG032965P, PFG033022P, PFG033239P, PFG033466P, PFG033562P, PFG033959P, PFG034105P, PFG034204P, PFG034332P, PFG034442P, PFG034568P, PFG050138P, PFG050143P, PFG050145P, PFG050163P, PFG050164P, PFG050174P, PFG050181P, PFG050190P, PFG050244P, PFG050245P, PFG050264P, PFG050265P, PFG050268P, PFG050272P, PFG050276P, PFG050286P, PFG050301P, PFG050324P, PFG050368P, PFG050377P, PFG050392P, PFG050394P, PFG050396P, PFG050467P, PFG050525P, PFG050527P, PFG050531P, PFG050534P, PFG050536P, PFG050537P, PFG050556P, PFG050559P, PFG050578P, PFG050581P, PFG050583P, PFG050584P, PFG050585P, PFG050591P, PFG050595P, PFG050596P, PFG050597P, PFG050612P, PFG050616P, PFG050654P, PFG050683P, PFG050689P, PFG050691P, PFG050692P, PFG050694P, PFG050711P, PFG050713P, PFG050714P, PFG050715P, PFG050718P, PFG050719P, PFG050722P, PFG050723P, PFG050742P, PFG050743P, PFG050744P, PFG050745P, PFG050752P, PFG050764P, PFG050766P, PFG050768P, PFG050771P, PFG050773P, PFG050774P, PFG050778P, PFG050779P, PFG050798P, PFG050799P, PFG050888P, PFG050889P, PFG050894P, PFG050918P, PFG050932P, PFG050934P, PFG050939P, PFG050944P, PFG050998P, PFG051011P, PFG051044P, PFG051047P, PFG051048P, PFG051049P, PFG051059P, PFG051084P, PFG051131P, PFG051132P, PFG051145P, PFG051147P, PFG051179P, PFG051180P, PFG051236P, PFG051282P, PFG051283P, PFG051289P, PFG051375P, PFG051446P, PFG051457P, PFG051511P, PFG051533P, PFG051534P, PFG051568P, PFG051570P, PFG051572P, PFG051612P, PFG051648P, PFG051656P, PFG051676P, PFG051692P, PFG051714P, PFG051718P, PFG051720P, PFG051788P, PFG051790P, PFG051792P, PFG051794P, PFG051796P, PFG051814P, PFG051816P, PFG051817P, PFG051873P, PFG051907P, PFG051913P, PFG051914P, PFG051927P, PFG051931P, PFG051951P, PFG051954P, PFG051955P, PFG051956P, PFG051957P, PFG051959P, PFG051960P, PFG052052P, PFG052053P, PFG052060P, PFG052075P, PFG052172P, PFG052174P, PFG052204P, PFG052230P, PFG052231P, PFG052234P, PFG052239P, PFG052240P, PFG052253P, PFG052274P, PFG052382P, PFG052391P, PFG052399P, PFG052400P, PFG052401P, PFG052416P, PFG052420P, PFG052429P, PFG052436P, PFG052507P, PFG052510P, PFG052600P, PFG052602P, PFG052610P, PFG052625P, PFG052633P, PFG052638P, PFG052639P, PFG052685P, PFG052688P, PFG052737P, PFG052738P, PFG052743P, PFG052856P, PFG052857P, PFG052858P, PFG052861P, PFG052863P, PFG052905P, PFG052906P, PFG052953P, PFG053007P, PFG053015P, PFG053016P, PFG053084P, PFG053085P, PFG053088P, PFG053134P, PFG053147P, PFG053154P, PFG053307P, PFG053327P, PFG053358P, PFG053359P, PFG053360P, PFG053361P, PFG053393P, PFG053396P, PFG053400P, PFG053405P, PFG053412P, PFG053479P, PFG053483P, PFG053486P, PFG053491P, PFG053539P, PFG053571P, PFG053615P, PFG100002R, PFG100007R, PFG100010R, PFG100012R, PFG100017R, PFG100019R, PFG100026R, PFG100028R, PFG100029R, PFG100040R, PFG100042R, PFG100055R, PFG100063R, PFG100065R, PFG100074R, PFG100076R, PFG100086R, PFG100088R, PFG100090R, PFG100095R, PFG100096R, PFG100105R, PFG100107R, PFG100121R, PFG100126R, PFG100129R, PFG100134R, PFG100143R, PFG100260R, PFG100333R, PFG100357R, PFG100361R, PFG100368R, PFG100376R, PFG100383R, PFG100411R, PFG100419R, PFG100420R, PFG100423R, PFG100427R, PFG100431R, PFG100443R, PFG100491R, PFG100512R, PFG100528R, PFG100530R, PFG100589R, PFG100808R, PFG100815R, PFG100822R, PFG100845R, PFG100846R, PFG100872R, PFG100891R, PFG100894R, PFG100902R, PFG101020R, PFG101021R, PFG101023R, PFG101059R, PFG101060R, PFG101073R, PFG101075R, PFG101078R, PFG101079R, PFG101092R, PFG101094R, PFG101097R, PFG101099R, PFG101100R, PFG101183R, PFG101200R, PFG101206R, PFG101242R, PFG101244R, PFG101293R, PFG101306R, PFG101317R, PFG101318R, PFG101321R, PFG101322R, PFG101334R, PFG101344R, PFG101352R, PFG101359R, PFG101371R, PFG101373R, PFG101394R, PFG101418R, PFG101419R, PFG101436R, PFG101536R, PFG101537R, PFG101659R, PFG101671R, PFG101683R, PFG101695R, PFG101720R, PFG101721R, PFG101726R, PFG101727R, PFG101865R, PFG101866R, PFG101867R, PFG101876R, PFG101892R, PFG101896R, PFG101897R, PFG101957R
RECALLING FIRM/MANUFACTURER
Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letters, dated October 2010 and November 2010
Manufacturer: Benchmark Electronics Inc., Winona, MN. Firm initiated recall is ongoing.
REASON
A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.
VOLUME OF PRODUCT IN COMMERCE
5595 (US 2696, OUS 2899) EXPANDED: 944 (852 US, 92 OUS)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Recall # Z-0456-2011
CODE
Lot numbers: A09279A and A09280A, Exp March 2010
RECALLING FIRM/MANUFACTURER
Abbott Point of Care Inc., Princeton, NJ, by letters dated March 2010. Firm initiated recall is ongoing.
REASON
The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
VOLUME OF PRODUCT IN COMMERCE
34,525 units
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets. Recall # Z-0538-2011
CODE
Unit: P10103
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2010.
Manufacturer: Medical Intelligence Medizintechnik Gmbh, Schwabmunchen, Germany. Firm initiated recall is ongoing.
REASON
The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. Recall # Z-0544-2011;

2) Allura XPER X-ray system. The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-0545-2011;

3) Allura XPER FD10 F/C The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-0546-2011;

4) ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-0547-2011;

5) ALLURA XPER FD20 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-0548-2011; 

6) ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-0549-2011
CODE
1) Site numbers: 41783749, 42892425, 43386703, and 43453378;

2) Site numbers: 531944, 105139, 105186, 520666, 520964, 530392, 534270, 534720, 534796, 535424, 536136, 536921, 537296, 538228, 557790, and 41444609;

3) Site numbers: 41444680, 41445250, 41445303, 41445766, 41446024, 41446262, 41622975, 42057739, 42799745, 42816302, 43151051, 43259235, 43270340, 43931289, and 43931292

4) Site numbers: 41660520, 43043666, 43164789, 43848923, and 44028554

5) Site numbers: 41443700, 41443700, 41444446, 41444463, 41445125, 41445246, 41445254, 41445255, 41445256, 41445336, 41445427, 41445434, 41445578, 41445804, 41446150, 41586608, 41792527, 42063953, 42066520, 42225697, 42478916, 42635423, 42635426, 42812038, 42892018, 42892474, 42919054, 43082276, 43120325, 43165011, 43209312, 43209348, 43263118, 43340698, 43392727, 43420965, 43421081, 43433587, 43443629, 43445198, 43594036, 43594037, 43622121, 43704085, 43721256, 43973609, 43973613, 44004308, 44004309, and 44038398;

6) Site numbers: 41445615, 41445628, 42479274, 42508759, 43315510, 43436747, 43443622, and 43635004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, letters on May 26, 2009 and June 4, 2009. 
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.
VOLUME OF PRODUCT IN COMMERCE
93 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) SODASORB Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton The indicator soda lime product is used for absorption of carbon dioxide in anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, sevoflurane, desflurane and isoflurane. Recall # Z-0560-2011;

2) Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted or upon moisture loss; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton Sodasorb LF is used for absorption of carbon dioxide in low flow anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, desflurane, sevoflurane and isoflurane. Recall # Z-0561-2011
CODE
1) Batch Numbers: CW10-P115-01, CW10-P115-02, CW10-P115-11, CW10-P115-12, CW10-P115-13, CW10-P115-17, CW10-P115-18, CW10-P115-21, CW10-P115-22, CW10-P115-23, CW10-P115-26, CW10-P115-27, CW10-P115-30, CW10-P115-32, CW10-P115-33, CW11-P115-01, CW11-P115-02, CW11-P115-03, CW11-P115-04, CW11-P115-05, CW11-P115-06, CW11-P115-07, CW11-P115-09, CW11-P115-11, CW11-P115-12, CW11-P115-13, CW11-P115-20, CW12-P115-03, CW12-P115-04, CW12-P115-05, CW12-P115-06, CW12-P115-07, CW12-P115-08, CW12-P115-10, CW12-P115-12, CX01-P115-01, CX01-P115-02, CX01-P115-03, CX01-P115-09, CX01-P115-10, CX01-P115-11, CX01-P115-14, CX01-P115-15, CX02-P115-05, CX02-P115-05, CX02-P115-06, CX02-P115-08, CX02-P115-09, CX02-P115-10, CX02-P115-11, CX02-P115-12, CX02-P115-13, CX03-P115-04, CX03-P115-05, CX03-P115-06, CX03-P115-07, CX03-P115-08, CX03-P115-09, CX03-P115-10, CX03-P115-12, CX03-P115-21, CX03-P115-22, CX03-P115-23, CX03-P115-26, CX03-P115-27, CX03-P115-28, CX03-P115-32, CX04-P115-01, CX04-P115-02, CX04-P115-05, CX04-P115-06, CX04-P115-07, CX04-P115-08, CX04-P115-09, CX04-P115-12, CX04-P115-13, CX04-P115-16, CX04-P115-17, CX04-P115-17, CX04-P115-19, CX04-P115-22, CX05-P115-05, CX05-P115-05, CX05-P115-06, CX05-P115-08, CX05-P115-10, CX05-P115-15, CX05-P115-16, CX05-P115-17, CX06-P115-03, CX06-P115-06, CX06-P115-07, CX06-P115-09, CX06-P115-10, CX06-P115-11, CX06-P115-12, CX06-P115-14, CX06-P115-15, CX06-P115-22, CX06-P115-23, CX06-P115-28, CX06-P115-29, CX07-P115-15, CX07-P115-16, CX07-P115-17, CX07-P115-20, CX07-P115-22, CX08-P115-04, CX08-P115-04, CX08-P115-05, CX08-P115-06, CX08-P115-10, CX09-P115-01, CX09-P115-02, CX09-P115-06, CX09-P115-07, CX09-P115-09, CX09-P115-10, CX09-P115-11, CX09-P115-18, CX09-P115-18, CX09-P115-19, CX09-P115-20, CX09-P115-21, CX09-P115-22, CX09-P115-23, CX09-P115-29, CX09-P115-29, CX09-P115-31, CX11-P115-01, CX11-P115-03, CX11-P115-06, CX11-P115-07, CX11-P115-09, CX11-P115-09, CX11-P115-09, CX12-P115-01, CX12-P115-01, CX12-P115-02, CX12-P115-02, CX12-P115-03, CX12-P115-04, CX12-P115-05, CX12-P115-06, CX12-P115-07, CX12-P115-08, CZ01-P115-01,CZ01-P115-02, CZ01-P115-03, CZ01-P115-04, CZ01-P115-06, CZ01-P115-07, CZ01-P115-08, CZ01-P115-08, CZ01-P115-11, CZ01-P115-11, CZ01-P115-12, CZ01-P115-13, CZ01-P115-14, CZ01-P115-14, CZ01-P115-18, CZ01-P115-19, CZ01-P115-20, CZ01-P115-21, CZ01-P115-22, CZ01-P115-23, CZ01-P115-24, CZ02-P115-07, CZ02-P115-11, CZ02-P115-11, CZ02-P115-13, CZ02-P115-14, CZ02-P115-15, CZ02-P115-16, CZ02-P115-18, CZ02-P115-19, CZ02-P115-21, CZ02-P115-22, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-10, CZ03-P115-11, CZ03-P115-12, CZ03-P115-13, CZ03-P115-13, CZ03-P115-14, CZ03-P115-15, CZ04-P115-01, CZ04-P115-02, CZ04-P115-03, CZ04-P115-04, CZ04-P115-05, CZ04-P115-08, CZ04-P115-09, CZ04-P115-10, CZ05-P115-02, CZ05-P115-03, CZ05-P115-04, CZ05-P115-05, CZ05-P115-07, CZ05-P115-08, CZ05-P115-09, CZ05-P115-10, CZ05-P115-11, CZ05-P115-15, CZ05-P115-16, CZ05-P115-17, CZ05-P115-18, CZ05-P115-19, CZ05-P115-20, CZ05-P115-21, CZ05-P115-22, CZ05-P115-23, CZ05-P115-24, CZ05-P115-25, CZ05-P115-26, CZ05-P115-27, CZ05-P115-28, CZ05-P115-32, CZ05-P115-33, CZ07-P115-06, CZ07-P115-07, CZ07-P115-08, CZ07-P115-11, CZ07-P115-13, CZ07-P115-14, CZ07-P115-15, CZ07-P115-17, CZ07-P115-20, CZ07-P115-21, CZ08-P115-01, CZ08-P115-02, CZ08-P115-09, CZ08-P115-10;

2) Batch Numbers: CX01-P128-04, CX01-P128-08, CX02-P128-04, CX02-P128-05, CX02-P128-08, CX06-P128-02, CX07-P128-01, CX07-P128-02, CX12-P128-03, CX12-P128-04, CX12-P128-05, CX12-P128-07, CZ03-P128-09, CZ07-P128-01, CZ07-P128-01, CZ07-P128-10 and CZ07-P128-11
RECALLING FIRM/MANUFACTURER
Darex Container Products Div of W.R. Grace & Co., Chicago, IL, by letters on October 20-22, 2010. Firm initiated recall is ongoing.
REASON
Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers.
VOLUME OF PRODUCT IN COMMERCE
103,638 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item code 8881580121. Recall # Z-0564-2011;

2) MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123. Recall # Z-0565-2011;

3) MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125. Recall # Z-0566-2011;

4) MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item code 8881590121. Z-0567-2011;

5) MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 3 ml in 12 ml syringe Item code 8881590123. Z-0568-2011;

6) MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item code 8881590125. Z-0569-2011
CODE
1) Lot # 9081964;
2) Lot # 90181964;
3) Lot # 9081974, 9081984, 9082034, 9082074, 9082084;
4) Lot # 9082094;
5) Lot # 9082094;
6) Lot # 9082104, 9082114, 9082154, 9092164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, by letter dated November 12, 2010,
Manufacturer: Mallinckrodt Canada, Inc., Pointe-Claire , Canada. Firm initiated recall is ongoing.
REASON
The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
VOLUME OF PRODUCT IN COMMERCE
3,510,720
DISTRIBUTION
Nationwide and Bermuda
___________________________________
PRODUCT
1) ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/018-13. The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. Recall # Z-0570-2011;

2) ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/014-17. The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. Recall # Z-0571-2011;

3) BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. The intramedullary reamer manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The reamer is used to open the mid to distal humeral canal to accept the implant. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. is used to open the mid to distal humeral canal to accept the implant. Recall # Z-0572-2011;

4) TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00. The intramedullary reamer is used to open the mid to distal humeral canal to accept the implant. Recall # Z-0573-2011;

5)  Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3 The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. Recall # Z-0574-2011;

6) Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. Recall # Z-0575-2011;

7) Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. Surgical Technique. Recall # Z-0576-2011
CODE
1) All lot numbers;
2) All lot numbers;
3) All lot numbers;
4) All lot numbers;
5) Rev. 3;
6) Rev. 3;
7) Rev. 4
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, letter dated September 10, 2010. Firm initiated recall is ongoing. 
REASON
The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
VOLUME OF PRODUCT IN COMMERCE
22,883 (distal pilots and reamers combined); Distal Trials = 9,790, Reamers = 13,093
DISTRIBUTION
Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand

___________________________________
PRODUCT
1) Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0577-2011;

2) Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0578-2011;

3) Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0579-2011

4) Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0580-2011

5) Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0581-2011;

6) McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0582-2011

7) NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. Recall # Z-0583-2011
CODE
All units sold (2005 – 2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teco Diagnostics, Anaheim, CA, by letter dated October 14, 2010.
Manufacturer: CHONG QING TECO HUAYI PHARM CO., SHIQIAOPU DISTRICT, CH, China. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Diagnostics cannot make claims that the CLIA-101 Urine Analyzer is safe or effective for measurement of urinary glucose occult blood and is therefore requesting all units be returned immediately. While there have been no adverse events reported, the potential exists
VOLUME OF PRODUCT IN COMMERCE
2,140 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism. Recall # Z-0584-2011;

2) Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use. Recall # Z-0585-2011
CODE
1) Lot Numbers: 992751;
2) Lot Numbers: 090013, 090121, and 090372
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated June 18, 2010.
Manufacturer: Diagnostic System Laboratories Inc., Webster, TX. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 992751 and 31% elevation for the I-PTH IRMA lot numbers above. The controls provided with the I-PTH ELIS and the I-PTH IRMA kits will not detect the incorrect results due to similarities between the calibrator and control formulations. The I-PTH kit controls will indicate that the test is performing properly, even though erroneous results may be generated. Quality control materials provided by other manufacturers may detect the instability as a trend before the out of control limit is reached.
VOLUME OF PRODUCT IN COMMERCE
196 kits
DISTRIBUTION
MD, NY, GA, NJ, CA, MI, TX, PA, IA, IN, Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation
___________________________________
PRODUCT
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
96AN-Bulk Pack Unlabeled Components (Catalog No. 96 AN-BPU-QUEST) for ANA Screening Test. Recall # Z-0608-2011
CODE
Lot No. 24591991, 24592395, 24500249, 24500250; Expiration date: 6/2010 (Lot 24952395); 12/2010
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated February 24, 2010. Firm initiated recall is ongoing.
REASON
The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
VOLUME OF PRODUCT IN COMMERCE
453 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0714-2011
CODE
All versions
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter dated October 21, 2010. Firm initiated recall is ongoing.
REASON
If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
VOLUME OF PRODUCT IN COMMERCE
219 units
DISTRIBUTION
Nationwide, Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela
___________________________________
PRODUCT
Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system. Model numbers 1818454, 1818447, and 1818959. Recall # Z-0718-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated October 25, 2010.
Manufacturer: Siemens Medical Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Battery fuse
VOLUME OF PRODUCT IN COMMERCE
191 units
DISTRIBUTION
AZ, CA, DC, MD, PA, SC and VA
___________________________________
PRODUCT
1) Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0795-2011;

2) Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0796-2011
CODE
1) Serial Numbers: 316001 315123 315913 316001 316070 318275 319856 320644 320806 321180 321554 321720 322009 322438 322483 322841 323064 323133 323239 323371 323401 323461 323529 323979 324168 324186 324671 324735 324781 324845 324981 325065 325205 325407 325468 325637 325760 325947 326005 326178 326187 326553 326680 326747 326805 326811 326815 326849 326853 326863 326895 327093 327195 327235 327414 327566 327590 327693 327700 327707 327741 327764 327979 327996 328000 328061 328086 328198 328239 328398 328519 328608 329064 329165 329231 329244 329294 329299 329387 329397 329414 329436 329441 329445 329487 329509 329590 329626 329649 329670 329713 329734 329793 329794 329823 329850 329857 329858 329879 329913 329948 329968 329988 330577 330773 330803 402329 402342 402535 402588 402597 402610 402613 402622 402630 402634 402638 402656 402663 402664 402684 402687 402694 402697 402717 402771 402772 402786 402800 402830 402831 402921 402934 402938 402939 402940 402941 402942 402943 402947 402948 402953 402976 402979 402982 402985 402987 402991 402994 403010 403020 403023 403025 403030 403037 403057 403069 403088 403098 403099 403100 403115 403122 403125 403135 403139 403142 403144 403150 403169 403172 403186 403199 403200 403231 403238 403264 403283 403335 403349 403380 403386 403397 403402 403420 403437 403445 403470 403488 403490 403495 403497 403498 403501 403502 403505 403512 403514 403516 403520 403527 403531 403540 403542 403552 403557 403562 403563 403566 403570 403572 403574 403597 403601 403607 403608 403609 403611 403617 403622 403623 403625 403644 403659 403667 403669 403695 403697 403711 403718 403758 403766 403790 403792 403798 403800 403812 403820 403823 403829 403834 403836 403849 403850 403852 403861 403862 403866 403870 403872 403874 403879 403885 403886 403888 403902 403907 403910 403911 403913 403915 403916 403917 403923 403924 403938 403941 403946 403949 403952 403976 403985 403989 403992 403997 404011 404018 404020 404055 404080 404081 404090 404104 404108 404111 404113 404118 404121 404125 404129 404131 404133 404139 404141 404143 404146 404149 404151 404156 404157 404168 404173 404181 404184 404191 404193 404199 404206 404212 404225 404227 404254 404255 404258 404270 404279 404319 404326 404372 404381 404402 404414 404415 404444 404456 404459 404483 404495 404500 404519 404521 404537 404550;

2) Serial Numbers: 352454 352743 352779 352908 353919 355514 355618 355700 355876 355889 356171 356180 356206 356361 356477 356561 356723 356746 356891 356900 356910 357104 357153 357171 357249 357265 357341 357417 357426 357452 357464 357490 357525 357548 357621 357645 357681 357687 357692 357696 357711 357772 357784 450211 450257 450346 450350 450363 450457 450487 450489 450495 450498 450511 450517 450521 450523 450525 450527 450530 450534 450535 450541 450545 450550 450552 450555 450559 450566 450567 450573 450581 450590 450624 450628 450661 450706 450721 450724 450727 450735 450817
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar, CA, by telephone on November 22, 2010, a Press Release on November 23, 2010, and letters on November 23, 2010, November 24, 2010, November 29th and 30th. Firm initiated recall is ongoing.
REASON
The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explanation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
VOLUME OF PRODUCT IN COMMERCE
414 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances. Recall # Z-0797-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated 14 October 2010. Firm initiated recall is ongoing.
REASON
A software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto ROI templates enabled.
VOLUME OF PRODUCT IN COMMERCE
182 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm). Intended use: Blood collection. Catalog Number 367342. Recall # Z-0816-2011
CODE
Lot numbers: 0145457, 0152300, 0153981, 0153982, 0158081, 0158082, 0158084, 0160664, 0160666, all exp 5/31/2012; Lot numbers 0165202, 0165205, 0165207, 0165218, 0165226, 0165227, 0165232, 0165234, 0176872, 0179208, 0179209, 0179212, 0180023, 0180026, 0180027, 0180028, 0180040, 0180042, all exp 6/30/2012; Lot numbers 0196209, 0196210, 0201399, 0201400, 0201402, 0208593, 0211641, all exp 7/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, and December 1, 2010.
Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.
REASON
There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.
VOLUME OF PRODUCT IN COMMERCE
4,223,200 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws. Recall # Z-0817-2011;

2) Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws. Recall # Z-0818-2011;

3) Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code: 2883-90-420 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws. Recall # Z-0819-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Spine, Inc., Raynham, MA, via e-mail on October 2, 2010. 
Manufacturer: Paragon Medical, Inc., Pierceton, IN. Firm initiated recall is ongoing.
REASON
The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy.
VOLUME OF PRODUCT IN COMMERCE
441 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Coloplast, Saline Filled Testicular Prosthesis, Sterile R. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline. Recall # Z-0820-2011
CODE
LOT Number 1. 786681 2. 787652 3. 790324 4. 791715 5. 795502 6. 1536948 7. 1544789 8. 1544791 9. 1544795 10. 1566824 11. 1566832 12. 1566834 13. 1566841 14. 1599021 15. 1635042 16. 1635044 17. 1635046 18. 1635048 19. 1635050 20. 1635052 21. 1635054 22. 1653937 23. 1653939 24. 1654196 25. 1672454 26. 1672456 27. 1672491 28. 1697164 29. 1697166 30. 1706415 31. 1744402 32. 1755277 33. 1767237 34. 1767244 35. 1813045 36. 1813047 37. 1813049 38. 1813051 39. 1822348 40. 1822352 41. 1846127 42. 1846129 43. 1846140 44.1867013 45. 1884873 46. 1884875 47. 1916030 48. 1919212 49. 1919214 50. 1919216 51. 1941770 52. 1941774 53. 1941776 54. 1941778 55. 1983824 56. 1983826 57. 2026772 58. 2026776 59. 2026778 60. 2026834 61. 2071113 62. 2071115 63. 2071117 64. 2071119 65. 2071139 66. 2074043 67. 2079379 68. 2079403 69. 2099145 70. 2099147 71. 2099782 72. 2101520 73. 2101526 74. 2101528 75. 2101584 76. 2101586 77. 2132513 78. 2132515 79. 2132517 80. 2132519 81. 2140442 82. 2140444 83. 2140446 84. 2140448 85. 2174381 86. 2174383 87. 2208887 88. 2208889 89.2208891 90. 2252377 91. 2252379 92. 2252381 93. 2264839 94. 2264841 95. 2264843 96. 2264848 97. 2276876 98. 2276878 99. 2276880 100. 2276882 101. 2313196 102. 2313198 103. 2313200 104. 2313202 105. 2350400 106. 2350402 107. 2350404 108. 2350406 109. 2350408 110. 5529691 111. 5529692 112. 5531496 113. 5580581 114. 5586999 115. 5587251 116. 5590238 117. 5597550 118. 5610612 119. 5612396 120. 5622524 121. 5675309 122. 5677197 123. 5685174 124. 5687319 125. 5687321 126. 5689613 127. 5695126 128. 5701149 129. 5707161 130. 5709326 131. 5710063 132. 5710266 133. 5710268 134. 5710664 135. 5711394 136. 5712307 137. 5714084 138. 5714086 139. 5714087 140. 5714088 141. 5714268 142. 5714829 143. 5715432 144. 5715433 145. 5715434 146. 5715437 147. 5715499 148. 5716316 149. 5716961 150. 5717266 151. 5717268 152. 5717554 153. 5717555 154. 5717705 155. 5717985 156. 5719252 157. 5720929 158. 5723254 159. 5723862 160. 5724292 161. 5724628 162. 5725587 163. 5725588 164. 5725589 165. 5725589 166. 5725591 167. 5725592 168. 5725594 169. 5726567 170. 5726571 171. 5727440 172. 5727441 173. 5727444 Terumo Butterfly Needle Lot Numbers Mfg. lot Number Lot Number 080916 0901190184 080615 0901140227 070414 4132672 070321 4132659 HD20 4129641 HC05 4129640 (Record illegible) 4126828 FF-05 4114382 FE25 4114295 EM18 4109685 EH22 4109365a EK17 4109365b DH07 41009 DH07 40943
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Manufacturing US, LLC, Mankato, MN, by letter dated April 30, 2010 and a follow-up letter dated May 1, 2010. 
Manufacturer: Coloplast Manufacturing US, LLC, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
The Saline Filled Testicular Prosthesis is considered mislabeled. This is solely due to a difference in expiration dates between the Terumo Butterfly Needle included in the kit and the testicular implant. The needle has a 3yr expiration date & the Saline Testicular has a 5yr expiration date. It is possible that the needle in the package has passed its expiration date, although some needles will not yet be expired. It is not acceptable that the 5year package includes a component that has a 3year shelf life, and this discrepancy meets FDAs definition of mislabeling, which is prohibited by law.
VOLUME OF PRODUCT IN COMMERCE
1018 units
DISTRIBUTION
Nationwide, Australia, Canada, Hong Kong, Chile, Columbia, Ecuador and Venezuela
___________________________________
PRODUCT
1) 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging. Material number: 10433816. Recall # Z-0826-2011;

2) ACUSON SC 2000 ultrasound system. Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes. Material Number: 10033682. Recall # Z-0827-2011
CODE
1) Serial numbers: 82638701 82741703 84254503 84355608 84455108 84754522 84857919 91861815 84858401 84655617 91654526 83044913 90261810 90864208 01288401 61101009 61601024 81631208 83146817 83251905 83751103 83752419 84455113 84557302 84753934 84857907 85056212 91503602 93771403 94982205 83650009 90656713 95183003 84456707 84153940 84857908 84857918 84953903 92068501 92256206 82540305 84053927 83853304 84656203 94065109;

2) Serial number of systems: 400212 400213 400215 400251 400405 400240 400089 400090 400104 400109 400149 400171 400289 400302 400334 400337 400183 400218 400209 400219 400259 400126 400247 400257 400260 400263 400281 400116 400165 400214 400420 400216 400253 400403 400412 400343 400185 400026 400044 400045 400084 400086 400088 400091 400102 400111 400114 400117 400118 400121 400124 400129 400132 400135 400139 400142 400143 400145 400146 400148 400156 400162 400168 400174 400176 400179 400202 400203 400206 400217 400220 400221 400222 400223 400224 400225 400227 400228 400229 400230 400232 400233 400234 400235 400236 400238 400239 400242 400243 400244 400258 400268 400269 400270 400272 400282 400287 400288 400290 400291 400293 400295 400297 400303 400304 400312 400314 400316 400336 400435 400449 400294 400127 400043 400125 400199 400200 400208 400113 400120 400237 400241 400332 400335 400413 400419 400158 400160 400161 400170 400172 400181 400182 400184 400187 400191 400201 400211 400249 400250 400299 400115 400155 400157 400207 400416 400424 400189 400195 400197 400166
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on September 29, 2010. Firm initiated recall is ongoing. 
REASON
There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
VOLUME OF PRODUCT IN COMMERCE
196 units
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom

___________________________________
PRODUCT
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray. Recall # Z-0829-2011
CODE
Unit: 1723336, 1768306, 2049011, ZB090424
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letters dated September 10, 2010.
Manufacturer: Biomet U.K., Ltd., Bridgend, South Wales, UK.  Firm initiated recall is ongoing.
REASON
The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Internationally only: Netherlands, Germany, France, Spain, Italy and Denmark
___________________________________
PRODUCT
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-0890-2011
CODE
All products
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter on July 6, 2010. Firm initiated recall is ongoing.
REASON
Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide, Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia
___________________________________
PRODUCT
C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery. Recall # Z-0910-2011
CODE
to be added later
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated October 8, 2009. Firm initiated recall is ongoing.
REASON
Product may deliver radiation treatment to areas larger than intended, to healthy tissue.
VOLUME OF PRODUCT IN COMMERCE
5,208 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered. Recall # Z-0924-2011
CODE
All units
RECALLING FIRM/MANUFACTURER
Mizuho Orthopedic Systems Inc., Union City, CA, by letter April 1, 2010. Firm initiated recall is ongoing.
REASON
Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT
1) Cholangioscopy Access Balloon, G54951, 15 mm, Rx only. This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones. Reorder number: DPOC-15. Recall # Z-0925-2011;

2) Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only. This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones. Reorder number DPOC-20. Recall # Z-0926-2011
CODE
1) Lot numbers: W2834630, W2835211, W2871208, W2871209, W2889215, W2889216, W2889217, W2889218, W2899398, W2899399, W2902200, W2902201, W2907649, W2907650, W2910395, W2910396, W2914136, W2914137, W2916501, W2916502, W2918945, W2918946, W2920993, W2920994, W2926799, W2926800, W2928562, W2928563, W2930338, W2930882, W2932781, W2932858, W2935202, W2935243 and WR2926438;

2) Lot number: W2834631
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter dated January 7, 2011. Firm initiated recall is ongoing.
REASON
Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide, Belgium, Canada, Germany, Hong Kong, and the Netherlands
___________________________________
PRODUCT
1) Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed. Catalog Number 8000-0313. Recall # Z-0927-2011;

2) Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed. Catalog Number 8001-0313. Recall # Z-0928-2011
CODE
1) Lot numbers: RD2M081; RD2M080, RD2N006; RD2L054; RD2M080E; RD2S005X1; RD2S005; RD2S60; RD2N006S; RD2S060S; RD2S059; RD2V064;RD2V063; RD2V067; RD2V068; RD2V067A; RD2V064E; RD2V068S; RD3A027M; RD2V067M; RD3A010A; RD2V068M; RD3A011H; RD3A009; RD2V068H; RD3A027H; RD3A070H; RD3A069; RD3A069H; RD3A070; RD3L033; RD3N205X1; RD3S020; RD3S094; RD3V086;

2) Lot # RD3N198 & Lot #RD3N200
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated December 30, 2010. Firm initiated recall is ongoing.
REASON
There is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument.
VOLUME OF PRODUCT IN COMMERCE
1) 237 units; 2) 6 units
DISTRIBUTION
Nationwide, Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom
___________________________________
PRODUCT
1) i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance. List numbers: 03M86-01, 03M86-02. Recall # Z-0929-2011;

2) i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance. List numbers: 06F01-01, 06F03-02. Recall # Z-0930-2011
CODE
1) Lot number: T10036A;
2) Lot number: P10033
RECALLING FIRM/MANUFACTURER
Abbott Point of Care Inc., Princeton, NJ, by letter dated July 2010. Firm initiated recall is ongoing.
REASON
Two cartridge lots were identified that may generate falsely elevated PCO2 results.
VOLUME OF PRODUCT IN COMMERCE
55,025 Nationwide, 325 Internationally
DISTRIBUTION
Nationwide, and countries of Oman and Turkey
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PRODUCT
Baxter Colleague Single Channel Volumetric Infusion Pump. Product Code: 2M8161. Recall # Z-0931-2011
CODE
Serial number: 15030799CC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on December 1, 2010.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
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PRODUCT
4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Model Number H48. Recall # Z-0932-2011
CODE

Codes: H510001 H510089 H510191 H510292 H510382 H510459 H510523 H510586 H510646 H510710 H510782 H510002 H510090 H510192 H510293 H510383 H510461 H510525 H510587 H510647 H510712 H510783 H510003 H510091 H510194 H510300 H510384 H510464 H510526 H510588 H510648 H510714 H510784 H510004 H510092 H510195 H510301 H510386 H510465 H510528 H510589 H510649 H510716 H510785 H510005 H510094 H510196 H510302 H510388 H510467 H510529 H510590 H510650 H510717 H510786 H510008 H510095 H510197 H510303 H510389 H510468 H510530 H510591 H510651 H510718 H510788 H510009 H510096 H510199 H510304 H510391 H510470 H510532 H510592 H510652 H510722 H510789 H510010 H510097 H510201 H510306 H510392 H510471 H510533 H510594 H510653 H510730 H510791 H510014 H510098 H510202 H510307 H510394 H510472 H510534 H510595 H510654 H510731 H510793 H510015 H510099 H510206 H510309 H510396 H510473 H510535 H510596 H510655 H510732 H510794 H510016 H510104 H510207 H510310 H510397 H510474 H510536 H510598 H510656 H510733 H510797 H510017 H510106 H510211 H510316 H510398 H510476 H510537 H510599 H510657 H510735 H510798 H510018 H510107 H510215 H510317 H510399 H510477 H510538 H510600 H510658 H510736 H510799 H510019 H510113 H510220 H510318 H510401 H510479 H510539 H510603 H510662 H510738 H510800 H510021 H510114 H510222 H510319 H510402 H510480 H510540 H510604 H510663 H510739 H510801 H510022 H510115 H510225 H510321 H510408 H510481 H510541 H510605 H510664 H510740 H510802 H510025 H510125 H510226 H510322 H510409 H510482 H510542 H510607 H510665 H510741 H510804 H510027 H510126 H510231 H510330 H510410 H510483 H510543 H510608 H510668 H510742 H510805 H510029 H510127 H510233 H510332 H510411 H510484 H510544 H510609 H510669 H510743 H510806 H510030 H510129 H510234 H510335 H510417 H510488 H510549 H510610 H510670 H510744 H510807 H510031 H510130 H510236 H510337 H510419 H510490 H510550 H510612 H510676 H510745 H510808 H510032 H510131 H510241 H510339 H510425 H510492 H510551 H510613 H510677 H510746 H510809 H510033 H510135 H510262 H510340 H510426 H510493 H510552 H510614 H510678 H510748 H510811 H510035 H510136 H510263 H510341 H510427 H510494 H510553 H510616 H510679 H510749 H510814 H510036 H510137 H510264 H510342 H510428 H510495 H510554 H510617 H510680 H510750 H510816 H510039 H510146 H510265 H510343 H510430 H510496 H510555 H510618 H510681 H510751 H510819 H510040 H510150 H510267 H510344 H510431 H510498 H510556 H510619 H510682 H510754 H510820 H510041 H510151 H510268 H510345 H510432 H510499 H510560 H510620 H510683 H510756 H510822 H510042 H510160 H510269 H510346 H510433 H510500 H510564 H510621 H510686 H510758 H510823 H510043 H510162 H510272 H510350 H510434 H510501 H510565 H510622 H510688 H510759 H510825 H510044 H510163 H510273 H510351 H510435 H510503 H510567 H510623 H510689 H510760 H510827 H510045 H510165 H510275 H510352 H510436 H510505 H510568 H510624 H510690 H510761 H510828 H510046 H510171 H510276 H510353 H510437 H510506 H510569 H510625 H510691 H510763 H510830 H510049 H510172 H510278 H510364 H510441 H510507 H510570 H510628 H510693 H510769 H510833 H510050 H510173 H510279 H510368 H510442 H510510 H510571 H510631 H510694 H510770 H510834 H510068 H510174 H510280 H510370 H510443 H510512 H510574 H510632 H510695 H510773 H510835 H510069 H510175 H510281 H510371 H510446 H510513 H510575 H510634 H510699 H510774 H510837 H510070 H510180 H510282 H510372 H510447 H510514 H510577 H510635 H510701 H510775 H510838 H510071 H510181 H510283 H510375 H510448 H510515 H510578 H510636 H510702 H510776 H510839 H510072 H510183 H510285 H510377 H510449 H510516 H510579 H510637 H510705 H510777 H510841 H510074 H510184 H510286 H510378 H510450 H510517 H510580 H510638 H510706 H510778 H510842 H510077 H510185 H510289 H510379 H510451 H510519 H510581 H510639 H510707 H510779 H510843 H510081 H510188 H510290 H510380 H510456 H510520 H510582 H510640 H510708 H510780 H510844 H510084 H510189 H510291 H510381 H510457 H510521 H510584 H510641 H510709 H510781 H510845 H510846 H510924 H510989 H511052 H511117 H511184 H511242 H511306 H511372 H511440 H511494 H510847 H510925 H510990 H511053 H511119 H511185 H511245 H511309 H511374 H511441 H511496 H510848 H510926 H510991 H511054 H511120 H511186 H511246 H511311 H511375 H511442 H511497 H510849 H510927 H510992 H511055 H511122 H511187 H511247 H511312 H511376 H511443 H511498 H510850 H510930 H510994 H511056 H511123 H511188 H511248 H511313 H511377 H511446 H511500 H510852 H510931 H510995 H511057 H511125 H511189 H511249 H511314 H511379 H511447 H511501 H510853 H510932 H510996 H511058 H511126 H511190 H511250 H511316 H511382 H511448 H511503 H510855 H510933 H510997 H511060 H511129 H511191 H511251 H511320 H511385 H511449 H511504 H510856 H510934 H510998 H511061 H511130 H511192 H511253 H511321 H511386 H511451 H511505 H510860 H510935 H510999 H511062 H511131 H511193 H511255 H511322 H511389 H511452 H511506 H510862 H510936 H511000 H511063 H511132 H511195 H511256 H511323 H511390 H511453 H511507 H510863 H510937 H511001 H511064 H511134 H511196 H511257 H511326 H511391 H511455 H511508 H510864 H510938 H511002 H511066 H511135 H511197 H511258 H511328 H511392 H511456 H511509 H510865 H510941 H511003 H511070 H511137 H511199 H511259 H511329 H511393 H511457 H511510 H510866 H510942 H511004 H511071 H511138 H511200 H511260 H511330 H511394 H511458 H511511 H510867 H510943 H511010 H511072 H511139 H511202 H511261 H511331 H511398 H511459 H511514 H510868 H510944 H511012 H511073 H511140 H511203 H511262 H511332 H511399 H511460 H511515 H510885 H510945 H511013 H511074 H511142 H511205 H511264 H511333 H511400 H511461 H511516 H510886 H510946 H511014 H511077 H511143 H511206 H511265 H511334 H511401 H511462 H511517 H510887 H510947 H511015 H511078 H511144 H511207 H511267 H511335 H511402 H511463 H511518 H510888 H510948 H511016 H511080 H511145 H511208 H511268 H511336 H511403 H511464 H511520 H510889 H510949 H511018 H511081 H511146 H511209 H511269 H511337 H511404 H511465 H511521 H510891 H510950 H511021 H511082 H511147 H511210 H511270 H511339 H511405 H511466 H511522 H510892 H510951 H511022 H511084 H511149 H511211 H511273 H511340 H511406 H511467 H511523 H510894 H510952 H511023 H511085 H511150 H511212 H511274 H511341 H511408 H511468 H511524 H510896 H510953 H511024 H511086 H511151 H511213 H511275 H511342 H511409 H511469 H511525 H510897 H510954 H511026 H511090 H511152 H511214 H511276 H511343 H511411 H511470 H511526 H510898 H510955 H511028 H511091 H511153 H511218 H511279 H511344 H511412 H511471 H511528 H510901 H510957 H511029 H511092 H511155 H511219 H511281 H511346 H511414 H511472 H511529 H510903 H510959 H511030 H511093 H511156 H511221 H511282 H511347 H511415 H511473 H511530 H510905 H510964 H511031 H511094 H511157 H511222 H511284 H511348 H511416 H511474 H511531 H510906 H510966 H511032 H511095 H511160 H511223 H511285 H511349 H511417 H511475 H511533 H510907 H510967 H511033 H511096 H511161 H511224 H511286 H511350 H511418 H511476 H511535 H510908 H510968 H511034 H511098 H511162 H511225 H511287 H511351 H511419 H511477 H511536 H510909 H510970 H511035 H511099 H511163 H511227 H511288 H511352 H511420 H511478 H511537 H510910 H510971 H511036 H511100 H511164 H511229 H511289 H511353 H511424 H511479 H511538 H510911 H510972 H511039 H511102 H511165 H511230 H511290 H511354 H511425 H511480 H511540 H510912 H510974 H511040 H511103 H511166 H511231 H511291 H511358 H511427 H511482 H511541 H510913 H510976 H511042 H511104 H511167 H511232 H511292 H511359 H511428 H511485 H511542 H510914 H510978 H511043 H511105 H511168 H511234 H511293 H511360 H511429 H511486 H511543 H510915 H510979 H511044 H511106 H511169 H511235 H511294 H511361 H511430 H511487 H511544 H510916 H510980 H511045 H511108 H511170 H511236 H511295 H511362 H511431 H511488 H511545 H510917 H510981 H511046 H511109 H511174 H511237 H511296 H511363 H511432 H511489 H511546 H510920 H510982 H511047 H511110 H511175 H511238 H511300 H511364 H511434 H511490 H511547 H510921 H510983 H511049 H511114 H511176 H511239 H511302 H511368 H511436 H511491 H511548 H510922 H510984 H511050 H511115 H511178 H511240 H511303 H511369 H511437 H511492 H511549 H510923 H510987 H511051 H511116 H511179 H511241 H511305 H511370 H511439 H511493 H511550 H511551 H511612 H511676 H511745 H511814 H511876 H511945 H512001 H512064 H512140 H512223 H511552 H511613 H511677 H511746 H511815 H511878 H511946 H512002 H512065 H512142 H512224 H511553 H511614 H511678 H511748 H511821 H511879 H511949 H512003 H512067 H512144 H512226 H511554 H511615 H511679 H511750 H511822 H511880 H511950 H512004 H512068 H512145 H512227 H511555 H511616 H511681 H511752 H511823 H511881 H511951 H512005 H512069 H512146 H512228 H511556 H511619 H511682 H511753 H511824 H511882 H511952 H512006 H512072 H512148 H512229 H511557 H511620 H511683 H511754 H511825 H511883 H511953 H512007 H512073 H512149 H512231 H511558 H511622 H511686 H511755 H511826 H511884 H511954 H512010 H512076 H512150 H512237 H511559 H511624 H511687 H511756 H511827 H511886 H511955 H512011 H512077 H512154 H512238 H511561 H511626 H511688 H511758 H511828 H511888 H511956 H512012 H512078 H512155 H512239 H511563 H511627 H511690 H511760 H511829 H511890 H511957 H512013 H512079 H512156 H512240 H511564 H511629 H511691 H511761 H511830 H511891 H511958 H512014 H512081 H512157 H512241 H511565 H511632 H511694 H511762 H511831 H511892 H511959 H512016 H512082 H512161 H512242 H511566 H511633 H511695 H511763 H511832 H511893 H511960 H512017 H512083 H512163 H512243 H511569 H511634 H511696 H511764 H511833 H511894 H511961 H512019 H512084 H512165 H512244 H511572 H511635 H511697 H511765 H511835 H511895 H511962 H512020 H512085 H512166 H512245 H511573 H511636 H511698 H511767 H511836 H511896 H511963 H512021 H512086 H512168 H512246 H511574 H511637 H511699 H511768 H511837 H511900 H511964 H512024 H512087 H512169 H512247 H511575 H511638 H511700 H511769 H511840 H511901 H511965 H512028 H512090 H512171 H512248 H511576 H511639 H511701 H511770 H511841 H511902 H511966 H512029 H512091 H512180 H512249 H511577 H511643 H511702 H511771 H511842 H511903 H511967 H512031 H512095 H512182 H512250 H511578 H511644 H511703 H511772 H511844 H511905 H511968 H512032 H512097 H512184 H512252 H511580 H511645 H511704 H511773 H511845 H511906 H511969 H512033 H512100 H512185 H512253 H511582 H511646 H511705 H511774 H511846 H511907 H511970 H512035 H512103 H512186 H512254 H511583 H511647 H511707 H511777 H511847 H511908 H511971 H512036 H512104 H512188 H512255 H511584 H511648 H511711 H511778 H511848 H511910 H511972 H512037 H512108 H512190 H512256 H511585 H511650 H511712 H511779 H511849 H511915 H511974 H512038 H512111 H512191 H512258 H511586 H511651 H511713 H511780 H511850 H511916 H511975 H512039 H512112 H512194 H512259 H511587 H511652 H511714 H511781 H511851 H511917 H511976 H512040 H512113 H512198 H512260 H511589 H511653 H511715 H511784 H511852 H511918 H511977 H512041 H512114 H512199 H512262 H511590 H511654 H511716 H511785 H511853 H511922 H511978 H512042 H512118 H512200 H512264 H511591 H511655 H511719 H511787 H511854 H511923 H511980 H512043 H512120 H512201 H512265 H511592 H511656 H511720 H511790 H511855 H511924 H511982 H512044 H512121 H512202 H512266 H511593 H511657 H511723 H511792 H511856 H511925 H511983 H512046 H512122 H512203 H512268 H511594 H511658 H511724 H511796 H511857 H511926 H511984 H512047 H512124 H512204 H512270 H511595 H511659 H511726 H511797 H511858 H511928 H511985 H512048 H512125 H512205 H512271 H511596 H511660 H511727 H511798 H511859 H511930 H511987 H512049 H512126 H512206 H512273 H511597 H511662 H511728 H511800 H511860 H511931 H511990 H512051 H512127 H512207 H512274 H511600 H511663 H511730 H511801 H511861 H511932 H511991 H512052 H512128 H512208 H512275 H511602 H511664 H511733 H511802 H511863 H511933 H511992 H512053 H512131 H512210 H512277 H511605 H511666 H511734 H511803 H511864 H511935 H511993 H512056 H512132 H512211 H512278 H511606 H511667 H511735 H511806 H511865 H511936 H511994 H512057 H512133 H512212 H512279 H511607 H511670 H511736 H511807 H511868 H511937 H511995 H512058 H512134 H512213 H512280 H511608 H511671 H511737 H511808 H511870 H511938 H511996 H512059 H512135 H512214 H512282 H511609 H511673 H511738 H511809 H511872 H511939 H511998 H512060 H512136 H512218 H512283 H511610 H511674 H511742 H511811 H511874 H511943 H511999 H512062 H512137 H512219 H512284 H511611 H511675 H511743 H511813 H511875 H511944 H512000 H512063 H512138 H512222 H512287 H512288 H512354 H512415 H512479 H512550 H512619 H512693 H512757 H512832 H512890 H512969 H512289 H512355 H512416 H512480 H512551 H512620 H512694 H512758 H512833 H512892 H512970 H512290 H512356 H512417 H512483 H512552 H512621 H512695 H512761 H512834 H512893 H512971 H512291 H512357 H512418 H512485 H512554 H512622 H512697 H512763 H512835 H512896 H512972 H512292 H512358 H512419 H512486 H512555 H512623 H512698 H512767 H512836 H512907 H512973 H512293 H512360 H512420 H512487 H512556 H512624 H512700 H512769 H512837 H512908 H512974 H512294 H512361 H512421 H512489 H512559 H512632 H512701 H512770 H512838 H512909 H512977 H512296 H512362 H512423 H512490 H512560 H512633 H512703 H512771 H512839 H512912 H512978 H512297 H512364 H512425 H512491 H512561 H512634 H512704 H512774 H512841 H512913 H512979 H512298 H512365 H512426 H512492 H512563 H512636 H512705 H512776 H512842 H512914 H512980 H512299 H512366 H512427 H512495 H512567 H512637 H512706 H512777 H512843 H512916 H512982 H512300 H512367 H512429 H512496 H512568 H512642 H512707 H512778 H512845 H512917 H512984 H512302 H512368 H512431 H512497 H512569 H512643 H512708 H512779 H512846 H512918 H512985 H512304 H512369 H512432 H512498 H512570 H512644 H512709 H512781 H512847 H512920 H512987 H512305 H512371 H512433 H512502 H512573 H512645 H512710 H512782 H512848 H512924 H512988 H512306 H512372 H512434 H512503 H512574 H512646 H512711 H512783 H512849 H512926 H512989 H512307 H512375 H512435 H512504 H512575 H512647 H512712 H512784 H512850 H512928 H512990 H512308 H512376 H512436 H512506 H512576 H512650 H512713 H512785 H512852 H512929 H512991 H512309 H512377 H512437 H512507 H512577 H512652 H512714 H512786 H512853 H512930 H512992 H512310 H512378 H512438 H512509 H512578 H512657 H512716 H512787 H512854 H512931 H512993 H512311 H512379 H512439 H512511 H512579 H512658 H512717 H512789 H512855 H512932 H512994 H512314 H512380 H512440 H512513 H512581 H512659 H512718 H512790 H512856 H512933 H512995 H512315 H512381 H512441 H512515 H512582 H512661 H512719 H512791 H512858 H512934 H512996 H512317 H512385 H512445 H512516 H512583 H512662 H512720 H512795 H512859 H512935 H512997 H512318 H512386 H512446 H512517 H512586 H512663 H512723 H512799 H512861 H512936 H512998 H512320 H512387 H512449 H512518 H512587 H512664 H512724 H512801 H512862 H512938 H513000 H512321 H512388 H512450 H512520 H512588 H512665 H512725 H512802 H512863 H512939 H513002 H512322 H512389 H512451 H512521 H512590 H512666 H512726 H512803 H512864 H512940 H513004 H512324 H512390 H512452 H512522 H512591 H512667 H512727 H512804 H512866 H512941 H513005 H512325 H512391 H512453 H512524 H512592 H512668 H512729 H512809 H512867 H512943 H513006 H512327 H512392 H512454 H512526 H512596 H512669 H512730 H512810 H512868 H512944 H513008 H512328 H512394 H512455 H512527 H512597 H512670 H512731 H512811 H512869 H512945 H513009 H512329 H512396 H512459 H512532 H512598 H512671 H512732 H512812 H512873 H512946 H513010 H512331 H512398 H512460 H512533 H512600 H512674 H512734 H512813 H512874 H512948 H513011 H512332 H512399 H512461 H512534 H512602 H512676 H512735 H512814 H512875 H512953 H513012 H512334 H512400 H512462 H512535 H512603 H512677 H512737 H512815 H512878 H512954 H513014 H512335 H512401 H512463 H512536 H512604 H512678 H512738 H512816 H512879 H512955 H513015 H512337 H512402 H512464 H512537 H512607 H512679 H512739 H512817 H512880 H512956 H513016 H512339 H512403 H512465 H512538 H512608 H512680 H512740 H512818 H512881 H512957 H513018 H512340 H512404 H512466 H512539 H512610 H512681 H512741 H512819 H512882 H512958 H513019 H512341 H512405 H512467 H512541 H512611 H512682 H512742 H512821 H512883 H512959 H513020 H512342 H512406 H512468 H512542 H512612 H512684 H512743 H512822 H512884 H512960 H513021 H512344 H512407 H512469 H512543 H512613 H512685 H512744 H512824 H512885 H512961 H513022 H512345 H512408 H512470 H512545 H512614 H512686 H512745 H512827 H512886 H512962 H513023 H512347 H512410 H512471 H512546 H512616 H512687 H512749 H512828 H512887 H512964 H513024 H512349 H512411 H512475 H512547 H512617 H512691 H512750 H512829 H512888 H512966 H513025 H512350 H512414 H512477 H512548 H512618 H512692 H512751 H512831 H512889 H512967 H513026 H513027 H513091 H513153 H513216 H513281 H513345 H513402 H513475 H513543 H513605 H513665 H513028 H513092 H513154 H513217 H513283 H513347 H513405 H513477 H513545 H513606 H513667 H513029 H513094 H513156 H513220 H513285 H513349 H513407 H513478 H513546 H513607 H513668 H513030 H513095 H513157 H513222 H513287 H513350 H513413 H513479 H513547 H513611 H513669 H513031 H513096 H513158 H513223 H513289 H513351 H513414 H513480 H513548 H513612 H513670 H513032 H513097 H513162 H513224 H513290 H513353 H513419 H513483 H513549 H513613 H513672 H513033 H513098 H513163 H513225 H513291 H513354 H513420 H513485 H513550 H513614 H513673 H513034 H513101 H513164 H513226 H513292 H513355 H513421 H513492 H513551 H513615 H513674 H513035 H513103 H513165 H513227 H513293 H513356 H513422 H513493 H513552 H513617 H513675 H513036 H513104 H513166 H513228 H513294 H513357 H513424 H513494 H513553 H513618 H513676 H513037 H513105 H513167 H513229 H513295 H513358 H513425 H513495 H513554 H513619 H513677 H513039 H513106 H513170 H513231 H513296 H513359 H513426 H513496 H513555 H513621 H513679 H513042 H513107 H513171 H513233 H513297 H513360 H513427 H513497 H513556 H513622 H513680 H513043 H513108 H513172 H513234 H513298 H513361 H513428 H513498 H513558 H513624 H513681 H513045 H513109 H513173 H513237 H513299 H513362 H513429 H513499 H513559 H513625 H513682 H513046 H513111 H513174 H513240 H513300 H513363 H513430 H513501 H513561 H513626 H513683 H513047 H513112 H513176 H513241 H513301 H513365 H513431 H513502 H513562 H513627 H513686 H513048 H513113 H513180 H513242 H513302 H513367 H513432 H513503 H513563 H513628 H513687 H513049 H513114 H513181 H513244 H513303 H513369 H513433 H513504 H513565 H513629 H513690 H513050 H513115 H513182 H513245 H513304 H513371 H513435 H513506 H513566 H513630 H513691 H513051 H513116 H513183 H513246 H513305 H513372 H513437 H513507 H513567 H513631 H513692 H513052 H513117 H513184 H513248 H513306 H513373 H513438 H513508 H513568 H513632 H513693 H513054 H513118 H513185 H513249 H513307 H513374 H513439 H513509 H513569 H513633 H513695 H513055 H513119 H513186 H513250 H513308 H513375 H513440 H513510 H513570 H513634 H513696 H513056 H513120 H513188 H513251 H513309 H513376 H513441 H513514 H513571 H513635 H513697 H513058 H513121 H513189 H513253 H513310 H513378 H513442 H513515 H513573 H513636 H513699 H513059 H513122 H513190 H513254 H513311 H513379 H513443 H513516 H513574 H513638 H513700 H513060 H513123 H513191 H513255 H513312 H513380 H513450 H513517 H513575 H513639 H513701 H513062 H513124 H513192 H513256 H513313 H513381 H513451 H513518 H513579 H513641 H513704 H513064 H513125 H513193 H513257 H513314 H513382 H513452 H513519 H513580 H513642 H513706 H513065 H513127 H513195 H513260 H513315 H513383 H513453 H513520 H513581 H513645 H513707 H513066 H513128 H513196 H513261 H513317 H513384 H513454 H513521 H513582 H513646 H513709 H513067 H513129 H513197 H513262 H513321 H513385 H513455 H513523 H513583 H513647 H513710 H513069 H513130 H513199 H513264 H513322 H513386 H513456 H513524 H513584 H513648 H513712 H513070 H513132 H513200 H513265 H513323 H513387 H513457 H513525 H513585 H513649 H513713 H513073 H513133 H513201 H513266 H513325 H513388 H513458 H513526 H513586

H513650 H513714 H513078 H513134 H513202 H513267 H513326 H513389 H513459 H513527 H513589 H513651 H513715 H513079 H513135 H513203 H513268 H513327 H513390 H513460 H513528 H513591 H513653 H513716 H513080 H513139 H513204 H513269 H513329 H513393 H513462 H513529 H513594 H513654 H513717 H513081 H513142 H513205 H513272 H513330 H513394 H513464 H513530 H513595 H513656 H513718 H513082 H513143 H513208 H513273 H513331 H513395 H513465 H513533 H513596 H513657 H513719 H513083 H513144 H513209 H513274 H513338 H513396 H513466 H513534 H513597 H513658 H513720 H513084 H513145 H513210 H513276 H513339 H513397 H513467 H513535 H513598 H513659 H513721 H513085 H513146 H513211 H513277 H513340 H513398 H513470 H513536 H513601 H513660 H513722 H513086 H513150 H513212 H513278 H513341 H513399 H513471 H513539 H513602 H513661 H513725 H513087 H513151 H513213 H513279 H513342 H513400 H513472 H513541 H513603 H513663 H513730 H513089 H513152 H513215 H513280 H513344 H513401 H513474 H513542 H513604 H513664 H513731 H513733 H513790 H513860 H513926 H513981 H514042 H514098 H514160 H514218 H514272 H514332 H513735 H513791 H513861 H513927 H513982 H514047 H514099 H514161 H514219 H514273 H514333 H513738 H513792 H513862 H513929 H513983 H514048 H514100 H514162 H514220 H514274 H514334 H513739 H513793 H513863 H513930 H513984 H514050 H514101 H514163 H514221 H514275 H514335 H513740 H513794 H513866 H513931 H513985 H514051 H514102 H514164 H514222 H514276 H514336 H513741 H513795 H513867 H513932 H513986 H514052 H514103 H514165 H514223 H514277 H514337 H513742 H513797 H513869 H513933 H513987 H514053 H514104 H514166 H514224 H514278 H514338 H513743 H513800 H513870 H513934 H513988 H514054 H514108 H514167 H514225 H514279 H514339 H513744 H513801 H513871 H513935 H513989 H514055 H514110 H514168 H514226 H514280 H514340 H513745 H513802 H513872 H513936 H513990 H514056 H514112 H514170 H514227 H514281 H514341 H513746 H513805 H513873 H513937 H513991 H514058 H514114 H514171 H514228 H514282 H514342 H513747 H513808 H513875 H513941 H513992 H514059 H514115 H514172 H514229 H514283 H514343 H513748 H513815 H513876 H513942 H513993 H514060 H514119 H514173 H514230 H514284 H514344 H513749 H513816 H513877 H513943 H513995 H514062 H514121 H514174 H514231 H514285 H514345 H513750 H513817 H513878 H513944 H513999 H514063 H514122 H514175 H514232 H514286 H514346 H513751 H513818 H513880 H513945 H514000 H514064 H514123 H514179 H514233 H514288 H514347 H513753 H513819 H513881 H513947 H514001 H514065 H514124 H514180 H514234 H514289 H514348 H513755 H513821 H513887 H513949 H514002 H514066 H514125 H514181 H514235 H514291 H514349 H513756 H513822 H513888 H513952 H514003 H514067 H514126 H514182 H514236 H514292 H514350 H513757 H513823 H513889 H513953 H514004 H514068 H514127 H514183 H514237 H514293 H514351 H513758 H513825 H513890 H513954 H514005 H514069 H514128 H514184 H514238 H514296 H514352 H513759 H513826 H513891 H513955 H514006 H514070 H514129 H514185 H514239 H514297 H514353 H513761 H513827 H513892 H513956 H514007 H514071 H514130 H514186 H514240 H514300 H514355 H513763 H513828 H513893 H513957 H514008 H514072 H514133 H514187 H514241 H514301 H514356 H513764 H513829 H513894 H513958 H514009 H514073 H514134 H514188 H514243 H514303 H514357 H513766 H513830 H513895 H513959 H514010 H514075 H514135 H514189 H514244 H514304 H514358 H513767 H513831 H513896 H513960 H514011 H514076 H514136 H514191 H514245 H514305 H514359 H513769 H513832 H513898 H513961 H514015 H514077 H514137 H514192 H514246 H514306 H514360 H513770 H513837 H513899 H513962 H514016 H514078 H514138 H514193 H514247 H514307 H514361 H513771 H513838 H513901 H513963 H514017 H514079 H514140 H514194 H514248 H514308 H514362 H513772 H513839 H513902 H513964 H514018 H514080 H514141 H514196 H514249 H514310 H514363 H513773 H513840 H513904 H513965 H514019 H514081 H514142 H514198 H514250 H514311 H514364 H513775 H513841 H513906 H513966 H514020 H514082 H514143 H514200 H514253 H514313 H514365 H513776 H513842 H513907 H513967 H514021 H514083 H514144 H514201 H514254 H514314 H514366 H513777 H513843 H513908 H513968 H514022 H514084 H514145 H514202 H514256 H514315 H514367 H513778 H513844 H513909 H513969 H514023 H514085 H514146 H514203 H514257 H514316 H514369 H513779 H513845 H513910 H513970 H514024 H514086 H514147 H514204 H514258 H514318 H514372 H513780 H513846 H513911 H513971 H514025 H514087 H514148 H514208 H514260 H514319 H514373 H513781 H513847 H513912 H513972 H514026 H514089 H514149 H514209 H514261 H514320 H514374 H513782 H513850 H513913 H513973 H514028 H514090 H514152 H514210 H514262 H514321 H514375 H513783 H513853 H513914 H513974 H514029 H514091 H514153 H514211 H514263 H514322 H514376 H513784 H513854 H513919 H513975 H514030 H514092 H514154 H514212 H514265 H514323 H514377 H513785 H513855 H513921 H513976 H514031 H514093 H514155 H514213 H514266 H514325 H514378 H513786 H513856 H513922 H513977 H514032 H514094 H514156 H514214 H514268 H514326 H514379 H513787 H513857 H513923 H513978 H514033 H514095 H514157 H514215 H514269 H514329 H514380 H513788 H513858 H513924 H513979 H514034 H514096 H514158 H514216 H514270 H514330 H514381 H513789 H513859 H513925 H513980 H514039 H514097 H514159 H514217 H514271 H514331 H514382 H514383 H514439 H514507 H514568 H514624 H514676 H514782 H514843 H514920 H515006 H515057 H514385 H514440 H514508 H514571 H514625 H514677 H514784 H514844 H514922 H515007 H515058 H514386 H514441 H514510 H514572 H514626 H514678 H514785 H514845 H514924 H515008 H515059 H514387 H514442 H514511 H514574 H514627 H514679 H514787 H514846 H514926 H515009 H515060 H514388 H514444 H514513 H514575 H514628 H514682 H514788 H514849 H514927 H515011 H515061 H514389 H514449 H514514 H514576 H514629 H514683 H514789 H514851 H514929 H515012 H515062 H514390 H514455 H514515 H514577 H514631 H514685 H514790 H514852 H514930 H515013 H515063 H514391 H514456 H514516 H514578 H514632 H514687 H514791 H514854 H514932 H515014 H515064 H514392 H514457 H514517 H514579 H514633 H514688 H514792 H514855 H514933 H515015 H515065 H514394 H514460 H514518 H514580 H514634 H514689 H514793 H514856 H514934 H515016 H515066 H514395 H514461 H514520 H514581 H514635 H514690 H514794 H514857 H514936 H515017 H515067 H514396 H514462 H514521 H514582 H514636 H514691 H514795 H514859 H514937 H515018 H515068 H514397 H514463 H514522 H514583 H514637 H514692 H514796 H514862 H514939 H515019 H515069 H514398 H514464 H514523 H514584 H514638 H514693 H514797 H514863 H514940 H515020 H515070 H514399 H514465 H514524 H514586 H514639 H514696 H514798 H514865 H514941 H515021 H515071 H514400 H514466 H514525 H514588 H514640 H514698 H514800 H514866 H514942 H515022 H515072 H514401 H514467 H514526 H514589 H514641 H514699 H514801 H514868 H514944 H515023 H515073 H514402 H514468 H514527 H514590 H514642 H514702 H514804 H514869 H514948 H515024 H515075 H514403 H514469 H514528 H514591 H514643 H514703 H514805 H514870 H514949 H515025 H515076 H514404 H514470 H514529 H514592 H514644 H514705 H514806 H514871 H514954 H515026 H515077 H514405 H514471 H514530 H514596 H514645 H514708 H514807 H514872 H514955 H515027 H515078 H514406 H514472 H514532 H514597 H514647 H514711 H514809 H514874 H514958 H515029 H515079 H514407 H514474 H514533 H514598 H514648 H514715 H514810 H514875 H514959 H515030 H515080 H514408 H514475 H514534 H514599 H514649 H514716 H514811 H514876 H514961 H515031 H515081 H514409 H514478 H514539 H514600 H514651 H514722 H514812 H514877 H514962 H515033 H515082 H514410 H514479 H514540 H514601 H514652 H514724 H514813 H514880 H514963 H515034 H515083 H514411 H514480 H514541 H514602 H514653 H514732 H514814 H514881 H514967 H515035 H515084 H514412 H514481 H514542 H514603 H514654 H514734 H514815 H514890 H514968 H515036 H515085 H514413 H514482 H514544 H514604 H514655 H514735 H514816 H514891 H514971 H515037 H515086 H514414 H514483 H514545 H514605 H514656 H514736 H514817 H514892 H514973 H515038 H515087 H514415 H514484 H514546 H514606 H514657 H514750 H514818 H514895 H514974 H515039 H515088 H514416 H514485 H514547 H514607 H514658 H514752 H514819 H514898 H514976 H515040 H515089 H514417 H514486 H514551 H514608 H514660 H514753 H514820 H514899 H514980 H515041 H515090 H514420 H514487 H514552 H514609 H514661 H514754 H514821 H514900 H514981 H515042 H515091 H514421 H514488 H514553 H514611 H514662 H514756 H514822 H514903 H514982 H515043 H515092 H514422 H514489 H514554 H514612 H514663 H514758 H514824 H514905 H514983 H515044 H515093 H514424 H514490 H514555 H514613 H514664 H514759 H514826 H514906 H514986 H515045 H515094 H514425 H514491 H514556 H514614 H514665 H514763 H514827 H514907 H514987 H515046 H515095 H514426 H514493 H514559 H514615 H514666 H514765 H514828 H514908 H514990 H515047 H515096 H514427 H514494 H514560 H514616 H514667 H514766 H514829 H514910 H514991 H515048 H515097 H514428 H514496 H514561 H514617 H514668 H514767 H514830 H514911 H514993 H515049 H515098 H514429 H514497 H514562 H514618 H514669 H514768 H514831 H514912 H514994 H515050 H515099 H514430 H514498 H514563 H514619 H514670 H514770 H514832 H514913 H514995 H515051 H515100 H514435 H514499 H514564 H514620 H514671 H514778 H514833 H514915 H515000 H515052 H515101 H514436 H514501 H514565 H514621 H514672 H514779 H514834 H514916 H515001 H515054 H515102 H514437 H514502 H514566 H514622 H514673 H514780 H514836 H514917 H515004 H515055 H515103 H514438 H514506 H514567 H514623 H514675 H514781 H514842 H514919 H515005 H515056 H515104 H515105 H515153 H515210 H515261 H515315 H515367 H515419 H515468 H515522 H515576 H515634 H515106 H515154 H515211 H515262 H515316 H515368 H515420 H515470 H515523 H515578 H515635 H515107 H515155 H515212 H515263 H515317 H515369 H515421 H515471 H515524 H515579 H515636 H515108 H515156 H515213 H515264 H515318 H515370 H515422 H515472 H515525 H515581 H515637 H515109 H515157 H515214 H515265 H515319 H515371 H515423 H515473 H515527 H515582 H515638 H515110 H515158 H515215 H515266 H515321 H515372 H515424 H515474 H515528 H515583 H515639 H515111 H515159 H515216 H515267 H515322 H515373 H515425 H515475 H515529 H515584 H515640 H515112 H515160 H515217 H515268 H515325 H515374 H515426 H515476 H515530 H515585 H515641 H515113 H515161 H515218 H515269 H515327 H515376 H515427 H515477 H515531 H515587 H515642 H515114 H515162 H515220 H515270 H515328 H515377 H515428 H515478 H515532 H515588 H515644 H515115 H515163 H515221 H515271 H515329 H515378 H515429 H515479 H515533 H515589 H515645 H515116 H515164 H515222 H515272 H515330 H515379 H515430 H515481 H515534 H515590 H515646 H515117 H515165 H515223 H515273 H515331 H515380 H515431 H515482 H515535 H515591 H515647 H515118 H515167 H515224 H515274 H515332 H515381 H515432 H515483 H515537 H515592 H515648 H515119 H515169 H515225 H515275 H515333 H515382 H515433 H515484 H515538 H515593 H515649 H515120 H515170 H515226 H515276 H515334 H515383 H515434 H515485 H515539 H515594 H515651 H515121 H515171 H515227 H515277 H515335 H515384 H515435 H515486 H515541 H515595 H515652 H515122 H515175 H515228 H515278 H515336 H515385 H515436 H515487 H515542 H515596 H515653 H515123 H515176 H515229 H515279 H515337 H515386 H515437 H515488 H515543 H515598 H515655 H515124 H515177 H515230 H515280 H515338 H515387 H515438 H515489 H515547 H515599 H515656 H515125 H515178 H515231 H515281 H515339 H515388 H515439 H515490 H515548 H515602 H515657 H515126 H515179 H515232 H515282 H515340 H515389 H515440 H515491 H515549 H515604 H515658 H515127 H515180 H515233 H515283 H515341 H515390 H515441 H515492 H515550 H515606 H515659 H515128 H515181 H515234 H515284 H515342 H515391 H515442 H515494 H515551 H515607 H515660 H515129 H515182 H515235 H515285 H515343 H515393 H515443 H515495 H515552 H515608 H515662 H515130 H515183 H515236 H515286 H515344 H515394 H515444 H515496 H515553 H515609 H515663 H515131 H515184 H515237 H515287 H515345 H515395 H515445 H515498 H515554 H515610 H515664 H515132 H515185 H515238 H515288 H515346 H515396 H515446 H515499 H515555 H515611 H515665 H515133 H515186 H515240 H515289 H515347 H515398 H515447 H515500 H515556 H515613 H515666 H515134 H515188 H515241 H515290 H515348 H515399 H515448 H515501 H515557 H515614 H515667 H515135 H515189 H515242 H515291 H515349 H515400 H515450 H515502 H515558 H515615 H515668 H515136 H515190 H515243 H515292 H515350 H515401 H515451 H515504 H515559 H515616 H515669 H515137 H515191 H515244 H515293 H515351 H515402 H515452 H515505 H515560 H515617 H515670 H515138 H515192 H515245 H515294 H515352 H515403 H515453 H515506 H515561 H515618 H515671 H515139 H515194 H515246 H515295 H515353 H515404 H515455 H515508 H515562 H515619 H515672 H515140 H515196 H515247 H515296 H515354 H515405 H515456 H515509 H515563 H515620 H515673 H515141 H515197 H515248 H515297 H515355 H515407 H515457 H515510 H515564 H515621 H515674 H515142 H515198 H515249 H515298 H515356 H515408 H515458 H515511 H515565 H515622 H515675 H515143 H515199 H515250 H515299 H515357 H515409 H515459 H515512 H515566 H515623 H515678 H515144 H515200 H515251 H515300 H515358 H515410 H515460 H515513 H515567 H515624 H515679 H515145 H515201 H515252 H515301 H515359 H515411 H515461 H515514 H515568 H515625 H515681 H515147 H515203 H515253 H515302 H515361 H515412 H515462 H515515 H515569 H515626 H515682 H515148 H515205 H515255 H515303 H515362 H515413 H515463 H515516 H515570 H515627 H515683 H515149 H515206 H515256 H515304 H515363 H515414 H515464 H515517 H515572 H515628 H515684 H515150 H515207 H515257 H515306 H515364 H515416 H515465 H515518 H515573 H515629 H515687 H515151 H515208 H515258 H515310 H515365 H515417 H515466 H515519 H515574 H515630 H515688 H515152 H515209 H515259 H515314 H515366 H515418 H515467 H515521 H515575 H515632 H515689 H515691 H515763 H515692 H515764 H515693 H515767 H515694 H515768 H515695 H515772 H515696 H515773 H515697 H515775 H515698 H515776 H515700 H515777 H515701 H515780 H515702 H515782 H515703 H515783 H515706 H515785 H515708 H515786 H515711 H515788 H515712 H515789 H515713 H515790 H515716 H515794 H515717 H515797 H515718 H515800 H515719 H515801 H515722 H515805 H515724 H515807 H515725 H515817 H515726 H515820 H515727 H516012 H515728 H517001 H515731 H517567 H515732 H518102 H515733 H518104 H515735 H518107 H515736 H518109 H515737 H518110 H515738 H518111 H515739 H518117 H515742 H518118 H515743 H518119 H515746 H519565 H515747 H515749 H515751 H515755 H515756 H515757 H515758 H515759 H515760
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on December 14, 2010. Firm initiated recall is ongoing.
REASON
Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present.
VOLUME OF PRODUCT IN COMMERCE
4,188 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Baxter FloGard 6201 Volumetric Infusion Pump. Product code 2M8063. For delivery of intravenous solutions, drug solutions, enteral feedings and blood. Recalling Firm: Z-0933-2011
CODE
Serial number 11091330FA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on November 17, 2010. Firm initiated recall is ongoing.  
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Recall # Z-0935-2011
CODE
Serial number: 12070599CC; Serial number 17086323CP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on December 1, 2010.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ, IN
___________________________________
PRODUCT
Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures. Part No: CL-07645. Recall # Z-0936-2011
CODE
Lot No: CF0014630
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, letter dated December 20, 2010.
Manufacturer: Arrow Internacional De Chihuahua, Chihuahua  31200, Mexico. Firm initiated recall is ongoing.
REASON
Packaging may have been compromised, and sterility of product cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
320 units
DISTRIBUTION
International distribution only: Australia, Bermuda, Czechoslovakia, Denmark, Greece, Indian Territory, and Luxembourg
___________________________________
PRODUCT
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital. Recall # Z-0937-2011
CODE

Serial Numbers: 1005, 1011, 1012, 1013, 1014, 2355, 80001, 80003, 80007, 80008, 80009, 80012, 80013, 80018, 80022, 80025, 80031, 80032, 80033, 80035, 80042, 80045, 80050, 80059, 80076, 80085, 80117, 80228, 80276, 80281, 80282, 80283, 80285, 80286, 80288, 80289, 80290, 80296, 80297, 80298, 80299, 80301, 80314, 80315, 80316, 80317, 80318, 80319, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80355, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80366, 80367, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80378, 80379, 80380, 80381, 80383, 80384, 80385, 80386, 80387, 80388, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80405, 80406, 80407, 80408, 80419, 80420, 80423, 80424, 80425, 80426, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80434, 80435, 80436, 80437, 80438, 80439, 80440, 80441, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 80459, 80460, 80461, 80462, 80463, 80464, 80465, 80466, 80467, 80468, 80475, 80476, 80478, 80487, 80488, 80489, 80490, 80491, 80492, 80493, 80495, 80496, 80497, 80498, 80499, 80500, 80501, 80502, 80503, 80504, 80505, 80506, 80507, 80508, 80509, 80510, 80511, 80512, 80513, 80514, 80515, 80516, 80517, 80518, 80519, 80520, 80521, 80523, 80524, 80525, 80531, 80532, 80533, 80534, 80535, 80536, 80539, 80540, 80542, 80543, 80554, 80555, 80556, 80557, 80558, 80559, 80560, 80564, 80569, 80571, 80572, 80574, 80575, 80576, 80577, 80578, 80579, 80580, 80581, 80582, 80583, 80584, 80585, 80586, 80587, 80589, 80590, 80591, 80592, 80593, 80594, 80596, 80597, 80600, 80602, 80603, 80604, 80605, 80606, 80607, 80608, 80609, 80611, 80616, 80617, 80618, 80619, 80620, 80621, 80622, 80624, 80625, 80627, 80628, 80629, 80632, 80637, 80638, 80639, 80640, 80641, 80642, 80643, 80644, 80645, 80646, 80647, 80648, 80649, 80650, 80651, 80652, 80653, 80654, 80655, 80656, 80657, 80658, 80659, 80660, 80662, 80663, 80664, 80665, 80666, 80667, 80672, 80673, 80674, 80675, 80676, 80677, 80678, 80679, 80680, 80681, 80682, 80683, 80684, 80685, 80686, 80687, 80689, 80690, 80691, 80692, 80693, 80694, 80695, 80696, 80697, 80699, 80702, 80703, 80704, 80705, 80706, 80707, 80711, 80713, 80714, 80715, 80716, 80717, 80718, 80719, 80720, 80721, 80722, 80723, 80724, 80725, 80726, 80727, 80728, 80729, 80730, 80731, 80755, 80756, 80757, 80758, 80759, 80761, 80762, 80763, 80764, 80765, 80766, 80767, 80768, 80769, 80770, 80771, 80778, 80779, 80781, 80782, 80783, 80784, 80785, 80786, 80787, 80788, 80789, 80790, 80791, 80792, 80794, 80795, 80796, 80797, 80798, 80799, 80800, 80801, 80802, 80803, 80807, 80808, 80809, 80810, 80822, 80823, 80824, 80826, 80827, 80838, 80839, 80840, 80841, 80842, 80843, 80844, 80845, 80847, 80848, 80849, 80850, 80851, 80852, 80855, 80856, 80857, 80858, 80859, 80860, 80861, 80862, 80863, 80864, 80865, 80867, 80868, 80869, 80870, 80871, 80872, 80873, 80874, 80875, 80876, 80877, 80878, 80879, 80880, 80881, 80882, 80883, 80884, 80885, 80886, 80887, 80891, 80913, 80914, 80915, 80916, 80917, 80919, 80920, 80921, 80922, 80923, 80925, 80926, 80927, 80928, 80929, 80930, 80931, 80932, 80934, 80935, 80936, 80937, 80939, 80940, 80941, 80942, 80943, 80944, 80945, 80946, 80947, 80948, 80949, 80950, 80951, 80960, 80961, 80962, 80963, 80964, 80965, 80966, 80967, 80968, 80969, 80971, 80972, 80973, 80974, 80975, 80976, 80977, 80978, 80979, 80980, 80982, 80983, 80984, 80985, 80987, 80988, 80989, 80990, 80991, 80992, 80993, 80994, 80995, 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81012, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81021, 81022, 81023, 81024, 81025, 81026, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81039, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81047, 81049, 81050, 81051, 81052, 81053, 81054, 81055, 81056, 81057, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81066, 81067, 81068, 81069, 81070, 81071, 81072, 81073, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81081, 81082, 81083, 81084, 81085, 81086, 81087, 81088, 81089, 81090, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81099, 81102, 81103, 81105, 81107, 81108, 81109, 81116, 81118, 81121, 81122, 81123, 81124, 81125, 81126, 81127, 81128, 81129, 81130, 81131, 81132, 81133, 81134, 81135, 81136, 81137, 81138, 81139, 81140, 81141, 81142, 81143, 81144, 81145, 81146, 81147, 81148, 81149, 81150, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81160, 81165, 81166, 81167, 81168, 81169, 81176, 81177, 81178, 81179, 81180, 81181, 81182, 81182, 81183, 81184, 81185, 81186,

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83158, 83159, 83160, 83161, 83162, 83163, 83164, 83165, 83166, 83167, 83168, 83169, 83170, 83171, 83172, 83198, 83199, 83200, 83201, 83202, 83203, 83204, 83205, 83206, 83207, 83208, 83209, 83210, 83211, 83212, 83213, 83214, 83215, 83216, 83217, 83218, 83219, 83220, 83221, 83222, 83223, 83224, 83225, 83228, 83230, 83233, 83237, 83255, 83288, 83289, 83290, 83291, 83368, 83369, 83370, 83400, 83401, 83402, 83403, 83404, 83405, 83406, 83407, 83414, 83415, 83416, 83417, 83418, 83420, 83421, 83422, 83423, 83424, 83425, 83426, 83428, 83440, 83441, 83442, 83443, 83499, 83500, 83501, 83502, 83503, 83504, 83505, 83506, 83507, 83508, 83509, 83510, 83511, 83512, 83513, 83514, 83515, 83516, 83517, 83578, 83579, 83580, 83633, 83644, 83645, 83654, 85009, 85010, 85011, 85012, 85013, 85026, 85027, 85028, 85029, 85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040, 85041, 85042, 85043, 85044, 85045, 85046, 85047, 85050, 85051, 85052, 85073, 85074, 85075, 85076, 85077, 85078, 85079, 85093, 85094, 85110, 85111, 85143, 85144, 85145, 85146, 85147, 85148, 85149, 85150, 85151, 85152, 85153, 85154, 85155, 85156, 85157, 85187, 85188, 85189, 85190, 85191, 85192, 85193, 85194, 85195, 85196, 85197, 85198, 85199, 85200, 85201, 85226, 85227, 85228, 85229, 85234, 85235, 85236, 85237, 85238, 85244, 85245, 85247, 85248, 85249, 85255, 85329, 85332, 85333, 85334, 85337, 85338, 85340, 85341, 85342, 85343, 85344, 85345, 85346, 85347, 85348, 85349, 85350, 85364, 85365, 85368, 85369, 85381, 85388, 85389, 85391, 85392, 85393, 85394, 85395, 85396, 85397, 85398, 85402, 85403, 85404, 85410, 85411, 85412, 85413, 85414, 85420, 85421, 85422, 85423, 85424, 85425, 85426, 85427, 85428, 85429, 85430, 85431, 85432, 85433, 85441, 85505, 85506, 85507, 85508, 85509, 85510, 85511, 85512, 85513, 85514, 85515, 85517, 85518, 85519, 85520, 85522, 85523, 85524, 85525, 85526, 85527, 85528, 85529, 85530, 85552, 85554, 85555, 85556, 85557, 85587, 85588, 85589, 85602, 85603, 85604, 85604, 85605, 85606, 85607, 85619, 85620, 85621, 85622, 85623, 85630, 85645, 85660, 85686, 85728, 85729, 85730, 85731, 85732, 85733, 85734, 85755, 85756, 85757, 85761, 85762, 85763, 85764, 85765, 85766, 85771, 85771, 85772, 85772, 85773, 85773, 85774, 85774, 85775, 85775, 85776, 85776, 85777, 85778, 85778, 85779, 85779, 85780, 85780, 85781, 85782, 85783, 85784, 85785, 85787, 85788, 85789, 85790, 85791, 85792, 85793, 85810, 85812, 85813, 85814, 85815, 85816, 85817, 85818, 85819, 85820, 85821, 85822, 85823, 85825, 85826, 85827, 85828, 85829, 85830, 85831, 85832, 85833, 85834, 85835, 85836, 85837, 85838, 85856, 85857, 85858, 85859, 85860, 85861, 85862, 85863, 85864, 85865, 85866, 85867, 85868, 85869, 85870, 85871, 85872, 85877, 85878, 85879, 85880, 85881, 85882, 85883, 85884, 85888, 85889, 85890, 85891, 85892, 85893, 85894, 85895, 85896, 85897, 85898, 85899, 85900, 85901, 85902, 85931, 85932, 85933, 85945, 85955, 85964, 85967, 85968, 85969, 85970, 86017, 86018, 86024, 86025, 86026, 86027, 86028, 86029, 86055, 86056, 86057, 86103, 86104, 86118, 86141, 86142, 86143, 86144, 86145, 86146, 86147, 86149, 86150, 86222, 86223, 86224, 86225, 86226, 86227, 86228, 86230, 86245, 86256, 86257, 86258, 86261, 86262, 86263, 86264, 86265, 86266, 86267, 86268, 86281, 86282, 86283, 86289, 86290, 86291, 86292, 86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320, 86321, 86322, 86323, 86324, 86325, 86326, 86327, 86328, 86334, 86335, 86358, 86359, 86385, 86387, 86388, 86389, 86390, 86391, 86392, 86393, 86394, 86395, 86396, 86397, 86398, 86399, 86400, 86411, 86412, 86419, 86420, 86489, 86490, 86491, 86495, 86496, 86497, 86498, 86499, 86533, 86534, 86535, 86536, 86537, 86538, 86539, 86540, 86541, 86542, 86543, 86544, 86545, 86546, 86562, 86563, 86564, 86575, 86599, 86600, 86640, 86641, 86642, 86643, 86644, 86650, 86651, 86663, 86664, 86665, 86666, 86667, 86668, 86669, 86676, 86677, 86678, 86683, 86684, 86696, 86711, 86712, 86713, 86714, 86715, 86716, 86717, 86718, 86767, 86768, 86769, 86770, 86771, 86778, 86819, 86835, 86836, 86837, 86838, 86840, 86848, 86851, 86871, 86872, 86873, 86874, 86875, 86876, 86877, 86878, 86879, 86880, 86881, 86882, 86883, 86973, 86999, 87000, 87001, 87002, 87003, 87004, 87005, 87007, 87008, 87009, 87010, 87011, 87012, 87012, 87013, 87014, 87015, 87027, 87029, 87030, 87309, 87310, 87327, 87328, 87329, 87330, 87331, 87332, 87333, 87334, 87335, 87336, 87337, 87338, 87339, 87340, 87341, 87342, 87343, 87344, 87345, 87347, 87348, 87349, 87350, 87351, 87352, 87403, 87404, 87413, 87414, 87415, 87416, 87417, 87418, 87420, 87572, 87573, 87574, 87575, 87584, 87588, 87589, 87590, 87591, 87592, 87593, 87594, 87595, 87596, 87597, 87598, 87599, 87600, 87601, 87602, 87603, 87604, 87605, 87606, 87607, 87632, 87633, 87667, 87668, 87669, 87670, 87671, 87683, 87684, 87685, 87686, 87687, 87688, 87689, 87690, 87691, 87692, 87693, 87694, 87695, 87696, 87697, 87698, 87699, 87700, 87701, 87702, 87703, 87704, 87705, 87706, 87707, 87708, 87728, 87729, 87730, 87731, 87732, 87733, 87734, 87735, 87736, 87737, 87738, 87739, 87740, 87741, 87742, 87776, 87777, 87778, 87779, 87780, 87781, 87782, 87783, 87789, 87790, 87792, 87793, 87794, 87795, 87796, 89003, 89004, 89005, 89006, 89007, 89008, 89009, 89010, 89011, 89012, 89013, 89014, 89015, 89016, 89020, 89021, 89022, 89023, 89026, 89027, 89028, 89029, 89030, 89033, 89034, 89035, 89054, 89056, 89057, 89058, 89059, 89060, 89061, 89062, 89063, 89064, 89065, 89073, 89074, 89075, 89076, 89077, 89078, 89081, 89082, 89083, 89084, 89085, 89086, 89087, 89088, 89089, 89090, 89091, 89092, 89093, 89094, 89095, 89096, 89097, 89098, 89099, 89100, 89101, 89102, 89103, 89104, 89119, 89120, 89121, 89122, 89123, 89124, 89125, 89126, 89127, 89142, 89143, 89144, 89145, 89146, 89147, 89148, 89149, 89150, 89151, 89152, 89153, 89154, 89155, 89156, 89157, 89158, 89159, 89160, 89161, 89162, 89163, 89164, 89165, 89166, 89186, 89187, 89188, 89189, 89190, 89191, 89192, 89193, 89194, 89197, 89198, 89199, 89219, 89220, 89221, 89222, 89223, 89224, 89225, 89232, 89233, 89234, 89235, 89236, 89237, 89238, 89240, 89251, 89252, 89253, 89254, 89256, 89299, 89300, 89301, 89302, 89303, 89304, 89305, 89306, 89307, 89308, 89331, 89332, 89334, 89336, 89337, 89349, 89350, 89351, 89352, 89353, 89354, 89355, 89356, 89357, 89358, 89359, 89366, 89366, 89367, 89368, 89399, 89400, 89402, 89403, 89404, 89405, 89406, 89407, 89412, 89413, 89414, 89420, 89480, 89502, 89505, 89506, 89507, 89508, 89509, 89510, 89511, 89511, 89512, 89512, 89513, 89513, 89534, 89535, 89536, 89562, 89563, 89564, 89605, 89606, 89610, 89646, 89647, 89648, 89686, 89687, 89688, 89689, 89718, 89719, 89720, 89761, 89762, 89793, 89815, 89816, 89817, 89818, 89819, 89820, 89821, 89822, 89863, 89881, 89882, 89922, 89923, 89924, 89927, 89928, 89929, 89930, 89931, 89932, 89933, 89934, 89935, 89936, 89937, 89938, 89939, 89940, 90002, 90003, 90004, 90005, 90006, 90007, 90008, 90009, 90010, 90011, 90012, 90013, 90014, 90015, 90020, 90030, 90031, 90032, 90033, 90034, 90035, 90036, 90037, 90047, 90048, 90049, 90050, 90051, 90052, 90053, 90054, 90055, 90056, 90057, 90058, 90059, 90060, 90063, 90064, 90066, 90067, 90074, 90080, 90081, 90164, 90165, 90166, 90209, 90210, 90211, 90212, 90213, 90271, 90272, 90273, 90308, 90309, 90320, 90321, 90322, 90364, 90365, 90366, 90402, 90403, 90404, 90405, 90406, 90407, 90408, 90409, 90410, 90411, 90412, 90413, 90414, 90415, 90416, 90417, 90503, 90504, 90505, 90506, 90507, 90508, 90510, 90511, 90516, 90517, 90518, 90519, 90533, 90534, 90562, 90570, 90571, 90572, 90573, 90637, 90700, 90712, 90724, 90725, 90726, 90731, 90732, 90733, 90734, 90735, 90736, 90737, 90738, 90739, 90740, 90741, 90742, 90743, 90744, 90745, 90746, 90747, 90748, 90749, 90750, 90751, 90752, 90753, 90754, 90755, 90756, 90757, 90758, 90759, 90760, 90761, 90762, 90763, 90764, 90765, 90766, 90796, 90797, 90840, 90888, 90889, 90890, 90891, 90900, 90901, 90934, 90935, 90960, 90961, 90962, 90963, 90964, 90969, 90970, 90971, 91079, 91129, 91140, 91141, 91142, 91143, 91144, 91145, 91146, 91147, 91148, 91149, 91150, 91151, 91152, 91154, 91155, 91156, 91199, 91200, 91201, 91202, 91233, 91234, 91235, 91238, 91290, 91295, 91446, 91447, 91495, 91498, 91499, 91500, 91503, 91505, 91506, 91507, 91508, 91509, 91536, 91569, 91570, 91571, 91572, 91575, 91576, 91577, 91578, 91579, 91580, 91581, 91582, 91583, 91585, 91587, 91588, 91589, 91590, 91591, 91592, 91593, 91594, 91595, 91598, 91599, 91600, 91601, 91602, 91603, 91604, 91606, 91607, 91608, 91608, 91609, 91610, 91610, 91611, 91612, 91613, 91615, 91616, 91618, 91619, 91621, 91623, 91624, 91626, 91631, 91632, 91633, 91636, 91637, 91638, 91639, 91640, 91641, 91642, 91643, 91651, 91652, 91653, 91654, 91656, 91657, 91658, 91660, 91661, 91662, 91664, 91665, 91666, 91669, 91670, 91671, 91672, 91675, 91678, 91679, 91681, 91723, 91735, 91736, 91741, 91742, 91743, 91744, 91748, 91749, 91750, 91751, 91752, 91753, 91754, 91755, 91756, 91757, 91758, 91759, 91774, 91775, 91776, 91777, 91778, 91889, 91890, 91891, 91892, 91892, 91893, 91893, 91894, 91895, 91896, 91923, 91924, 92021, 92024, 92105, 92106, 92107, 92108, 92110, 92111, 92113, 92114, 92115, 92116, 92117, 92118, 92119, 92120, 92121, 92122, 92123, 92124, 92125, 92126, 92127, 92128, 92129, 92130, 92131, 92132, 92133, 92134, 92135, 92135, 92136, 92137, 92138, 92139, 92140, 92141, 92142, 92143, 92144, 92145, 92146, 92147, 92148, 92149, 92150, 92151, 92152, 92153, 92154, 92155, 92156, 92157, 92158, 92159, 92160, 92161, 92162, 92195, 92219, 92220, 92224, 92225, 92226, 92227, 92228, 92229, 92230, 92235, 92236, 92237, 92238, 92239, 92242, 92243, 92246, 92247, 92253, 92254, 92257, 92258, 92259, 92259, 92260, 92260, 92261, 92262, 92263, 92264, 92265, 92316, 92317, 92318, 92319, 92320, 92321, 92322, 92323, 92324, 92325, 92326, 92327, 92328, 92329, 92330, 92331, 92332, 92333, 92334, 92335, 92336, 92337, 92339, 92340, 92340, 92341, 92342, 92343, 92344, 92345, 92346, 92348, 92364, 92364, 92365, 92365, 92366, 92367, 92368, 92369, 92371, 92371, 92372, 92373, 92424, 92439, 92440, 92462, 92463, 92477, 92478, 92479, 92480, 92522, 92538, 92539, 92540, 92541, 92542, 92548, 92549, 92550, 92551, 92552, 92557, 92558, 92559, 92565, 92566, 92567, 92568, 92568, 92569, 92570, 92570, 92571, 92572, 92572, 92573, 92573, 92574, 92575, 92576, 92577, 92578, 92579, 92580, 92582, 92583, 92584, 92585, 92586, 92587, 92588, 92589, 92590, 92591, 92592, 92593, 92594, 92595, 92596, 92597, 92598, 92599, 92600, 92601, 92602, 92603, 92604, 92605, 92606, 92607, 92608, 92658, 92659, 92659, 92660, 92662, 92663, 92667, 92668, 92669, 92670, 92671, NF160001, NF160001, NF160002, NF160002, NF160003, NF160003, NF160004, NF160004, NF160005, NF160005, NF160006, NF160006, NF160007, NF160007, NF160008, NF160008, NF160009, NF160009, NF160010, NF160010, NF160011, NF160011, NF160012, NF160013, NF160014, NF160015, NF160016, NF160017, NF160018, NF160019, NF160020, NF160021, NF160022, NF160023, NF160024, NF160025, NF160026, NF160027, NF160028, NF160029, NF160030, NF160031, NF160032, NF160033, NF160034, NF160035, NF160036, NF160037, NF160038, NF160039, NF160040, NF160041, NF160042, NF160043, NF160044, NF160045, NF160046, NF160047, NF160048, NF160049, NF160050, NF160051, NF160053, NF160054, NF160055, NF160056, NF160057, NF160058, NF160059, NF160060, NF160061, NF160062, NF160063, NF160064, NF160065, NF160066, NF160067, NF160068, NF160069, NF160070, NF160071, NF160072, NF160073, NF160074, NF160075, NF160076, NF160077, NF160078, NF160079, NF160080, NF160081, NF160082, NF160083, NF160084, NF160085, NF160086, NF160087, NF160088, NF160089, NF160090, NF160091, NF160092, NF160093, NF160094, NF160095, NF160096, NF160097, NF160098, NF160099, NF160100, NF160101, NF160102, NF160103, NF160104, NF160105, NF160106, NF160107, NF160108, NF160109, NF160110, NF160111, NF160112, NF160113, NF160114, NF160115, NF160116, NF160117, NF160118, NF160119, NF160120, NF160121, NF160122, NF160123, NF160124, NF160125, NF160126, NF160127, NF160128, NF160129, NF160130, NF160131, NF160132, NF160133, NF160134, NF160135, NF160136, NF160137, NF160138, NF160139, NF160140, NF160141, NF160142, NF160143, NF160144, NF160145, NF160146, NF160147, NF160148, NF160149, NF160150, NF160151, NF160152, NF160153, NF160154, NF160155, NF160156, NF160157, NF160158, NF160159, NF160160, NF160161, NF160162, NF160163, NF160164, NF160165, NF160166, NF160167, NF160168, NF160169, NF160170, NF160171, NF160172, NF160173, NF160174, NF160175, NF160176, NF160177, NF160178, NF160179, NF160180, NF160181, NF160182, NF160183, NF160184, NF160185, NF160186, NF160187, NF160188, NF160189, NF160190, NF160191, NF160192, NF160193, NF160194, NF160195, NF160196, NF160197, NF160198, NF160199, NF160200, NF160201, NF160202, NF160203, NF160204, NF160205, NF160206, NF160207, NF160208, NF160209, NF160210, NF160211, NF160212, NF160213, NF160214, NF160215, NF160216, NF160217, NF160218, NF160219, NF160220, NF160221, NF160222, NF160223, NF160224, NF160225, NF160226, NF160227, NF160228, NF160229, NF160230, NF160231, NF160232, NF160233, NF160234, NF160235, NF160236, NF160237, NF160238, NF160239, NF160240, NF160241, NF160242, NF160243, NF160244, NF160245, NF160246, NF160247, NF160248, NF160249, NF160250, NF160251, NF160252, NF160253, NF160254, NF160255, NF160256, NF160257, NF160258, NF160259, NF160260, NF160261, NF160262, NF160263, NF160264, NF160265, NF160266, NF160267, NF160268, NF160269, NF160270, NF160271, NF160272, NF160273, NF160274, NF160275, NF160276, NF160277, NF160278, NF160279, NF160280, NF160281, NF160282, NF160283, NF160284, NF160285, NF160286, NF160287, NF160288, NF160289, NF160290, NF160291, NF160292, NF160293, NF160294, NF160295, NF160296, NF160297, NF160298, NF160299, NF160300, NF160301, NF160302, NF160303, NF160304, NF160305, NF160306, NF160307, NF160308, NF160309, NF160310, NF160311, NF160312, NF160313, NF160314, NF160315, NF160316, NF160317, NF160318, NF160319, NF160320, NF160321, NF160322, NF160323, NF160324, NF160325, NF160326, NF160327, NF160328, NF160329, NF160330, NF160331, NF160332, NF160333, NF160334, NF160335, NF160336, NF160337, NF160338, NF160339, NF160340, NF160341, NF160342, NF160343, NF160344, NF160345, NF160346, NF160347, NF160348, NF160349, NF160350, NF160351, NF160352, NF160353, NF160354, NF160355, NF160356, NF160357, NF160358, NF160359, NF160360, NF160361, NF160362, NF160363, NF160364, NF160365, NF160366, NF160367, NF160368, NF160369, NF160370, NF160371, NF160372, NF160373, NF160374, NF160375, NF160376, NF160379, NF160380, NF160381, NF160382, NF160383, NF160384, NF160385, NF160386, NF160387, NF160388, NF160389, NF160390, NF160391, NF160392, NF160393, NF160394, NF160395, NF160396, NF160397, NF160400, NF160401, NF160402, NF160403, NF160404, NF160405, NF160406, NF160407, NF160408, NF160409, NF160410, NF160411, NF160412, NF160413, NF160414, NF160415, NF160416, NF160417, NF160418, NF160419, NF160420, NF160421, NF160422, NF160423, NF160424, NF160425, NF160426, NF160427, NF160428, NF160429, NF160430, NF160431, NF160432, NF160433, NF160434, and P1011
RECALLING FIRM/MANUFACTURER
Welch Allyn Protocol, Inc., Beaverton, OR, by letter on September 17, 2010 and September 24, 2010. Firm initiated recall is ongoing. 
REASON
Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
VOLUME OF PRODUCT IN COMMERCE
2002 units Nationwide; 1604 units International
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0. Recall # Z-0939-2011
CODE
Serial numbers: VNT10-0102 thru VNT10-0128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sound Surgical Technologies, LLC, Louisville, CO. by e-mail on December 21, 2010.
Manufacturer: Linemaster Switch Corp., Woodstock, CT. Firm initiated recall is ongoing.
REASON
Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX
___________________________________
PRODUCT
1) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-100-000. Recall # Z-0947-2011;

2) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-100-000E. Z-0948-2011;

3) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-110-000. Recall # Z-0949-2011;

4) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-110-000E. Recall # Z-0950-2011;

5) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-114-000. Recall # Z-0951-2011;

6) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-114-000E. Recall # Z-0952-2011;

7) The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds. Part Number 0210-210-000. Recall # Z-0953-2011
CODE
1) Lot Numbers 09362012 and 09362022 Expires 12/1/2011;
2) Lot Number 09362012 Expires 12/1/2011;
3) Lot Numbers 09357012, 09357022 and 09364012 Expires 12/1/2011;
4) Lot Numbers 09357012, 09363012 and 09363022; Expires 12/1/2011;
5) Lot Number 09363012; Expires 12/1/2011;
6) Lot Number 09364012; Expires 12/1/2011;
7) Lot Number 09364012; Expires 12/1/2011
RECALLING FIRM/MANUFACTURER
Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated October 8, 2010. Firm initiated recall is ongoing.
REASON
There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
VOLUME OF PRODUCT IN COMMERCE
3,187 units
DISTRIBUTION
Nationwide, and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK
___________________________________
PRODUCT
Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO. Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics. Recall # Z-0954-2011
CODE
Lot Numbers: 188856, 190048, 190107, and 190307 through 193333 (88 lots) 
RECALLING FIRM/MANUFACTURER
Covidien LP, Boulder, CO, by letter dated December 6, 2010. Firm initiated recall is ongoing.
REASON
During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
VOLUME OF PRODUCT IN COMMERCE
25,009 units
DISTRIBUTION
Nationwide and Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay
___________________________________
PRODUCT
1) Stockert, S5 Roller Pump 150, Part No.: 10-80-00. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0956-2011;

2) Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0957-2011;

3) S5 Display and Control Module, Part No.: 28-95-10. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0958-2011;

4) S5 Mast Roller Pump System 85, Part No.: 28-95-80. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0959-2011;

5) S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0960-2011;

6) SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0961-2011;

7) 2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0962-2011;

8) SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0963-2011;

9) S5 C5-System, Part No.: 58-00-00. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0964-2011;

10) SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. Recall # Z-0965-2011
CODE
1) Serial Numbers: 10E00287 to 10E04007;
2) Serial Numbers: 10E50021 to 10E51124;
3) Serial Numbers: 28E50183 to 28E55913;
4) Serial Numbers: 50E60123 to 50E60276;
5) Serial Numbers: 50E65159 to 50E65165;
6) Serial Numbers: 50K00313 to 50K00693;
7) Serial Numbers: 50E50153, 50E0154, 50K00332 to 50K00685;
8) Serial Numbers: 50K00343 to 50K00688;
9) Serial Numbers: 58E00009 to 58E00026;
10) Serial Numbers: 50K00314 to 50K00694
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sorin Group USA, Inc., Arvada, CO, by letter on November 12, 2010.
Manufacturer: Sorin Group Deutschland GmbH, Munchen, Germany. Firm initiated recall is ongoing.
REASON
Touch screen may become unresponsive, inhibiting user input.
VOLUME OF PRODUCT IN COMMERCE
2,224 units Nationwide; 4,447 units International
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525 The StaXx XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx XD System is the CapSure PS Spine System. Recall # Z-0967-2011
CODE
Lot #572H09 Use by 2012-06
RECALLING FIRM/MANUFACTURER
Spine Wave Inc., Shelton, CT, by telephone on October 22, 2010. Firm initiated recall is complete.
REASON
Package Insert Incorrect.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
DE, MD, MA, NY
___________________________________
PRODUCT
Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589. The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used with the Sarns Sternal Saw System. Recall # Z-0968-2011
CODE
Units: 0505258, 0510335, 0519809, 0524042, 0531107, 0533191, 0536444, 0538524, 0541634, 0545325, 0547867, 0552336, 0561753, 0561751, 0561752, 0557559, 0564337, 0570411, 0571613, 0573009, 0577882, 0581075, 0584965, 0587430, 0585731, 0585730, 0585732, 0598360, 0601970 and 0605113
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated October 20, 2010. Firm initiated recall is ongoing.
REASON
The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterilized but the product actually was sterilized with gamma radiation.
VOLUME OF PRODUCT IN COMMERCE
42,670 items in 4,267 boxes (10 per box)
DISTRIBUTION
Nationwide, , Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uruguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand
___________________________________
PRODUCT
RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night. Recall # Z-0970-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Sleep Modus, Inc., Dallas, TX, by e-mail on September 15, 2010 and October 7, 2010. Firm initiated recall is complete.
REASON
Device had no 510(k) clearance prior to patient use.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilator. Recall # Z-0971-2011;

2) Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators. Recall # Z-0972-2011
CODE
1) Lot Number: 09072710;
2) Lot Numbers: 09072210 09081310, 09082510, 05091510
RECALLING FIRM/MANUFACTURER
Biomed Devices, Guilford, CT, by letter dated October 18, 2010. Firm initiated recall is ongoing.
REASON
Breathing circuit may disconnect between the adapter adjacent tubing cuff.
VOLUME OF PRODUCT IN COMMERCE
16 cases
DISTRIBUTION
OH, WI
___________________________________
PRODUCT
1) KING LT -D Size 3, 10-0002, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0974-2011;

2) KING LT -D, Size 4, 10-0003, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0975-2011;

3) KING LT -D, Size 5, 10-0004, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0976-2011;

4) KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0977-2011;
5) KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0978-2011;
6) KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0979-2011;
7) Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0980-2011;
8) Cardiac ResQ Kit, Size 4, CRQ424. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0981-2011;
9) Cardiac ResQ Kit, Size 5, CRQ425. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0982-2011;

10) KING LT -D Laryngeal Tube, Size 2, KLTD202. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0983-2011;

11) KING LT -D Laryngeal Tube, Size 2.5, KLTD2025. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0984-2011;

12) KING LT -D Lanyngeal Tube, Size 3, KLTD203. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0985-2011;

13) KING LT -D Laryngeal Tube, Size 4, KLTD204. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall # Z-0986-2011
CODE
All product produced prior to 12/09
RECALLING FIRM/MANUFACTURER
King Systems Corp., Noblesville, IN, by letter on October 29, 2009. Firm initiated recall is ongoing.
REASON
Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulatory and office-based anesthesia. Promotional materials, indications statements and instructions for use encourage use of device in patient populations not covered by cleared 510(K)s.
VOLUME OF PRODUCT IN COMMERCE
25,000 units
DISTRIBUTION
Nationwide, Canada, Costa Rica, and Panama

___________________________________
PRODUCT
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Recall # Z-0987-2011
CODE
Serial numbers: KVN 0001 through KVN 1071
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated December 17, 2010. Firm initiated recall is ongoing.
REASON
Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.
VOLUME OF PRODUCT IN COMMERCE
1,071 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9”, Contains Phthalates, Sterile EO, Sterile R. The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perperfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters. Recall # Z-0991-2011;

2) Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO. The Steerable Coronary Sinus Catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters. Recall # Z-0992-2011
CODE
1) Lot Numbers: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334;

2) Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences LLC, Draper, UT, by letter dated December 3, 2010.
Manufacturer: Edwards Lifesciences Research Medical, Inc., Midvale, UT. Firm initiated recall is ongoing.
REASON
Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
VOLUME OF PRODUCT IN COMMERCE
3,517 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS III
___________________________________
PRODUCT
1) Baxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter Extension Set Kit; 7.6" (19.3 cm), Vol. 1.0 mL, 1 Catheter Extension Set with Luer Activated Device with Silver for IV Access and Male Luer Lock Adapter with Retractable Collar, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 6N8220. Recall # Z-0351-2011;

2) Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension St with luer activated device with silver for IV Access and Male Luer Lock Adapter, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 6N8222. Recall # Z-0352-2011;

3) Baxter Catheter Stabilization Device; 1 VITAL-HOLD Medium Catheter Stabilization Device with 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 2N8200. Recall # Z-0353-2011;

4) Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 7.7" (20.0 cm), Vol. 1.10 mL, 1 Catheter Extension Set with Luer Activated Valve for IV access and Male Luer Lock Adapter, 1 VITAL-HOLD Medium Catheter Stabilization Device with 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 2N8220. Recall # Z-0354-2011;

5) Baxter INTERLINK System, Non-DEHP Catheter Extension Set Kit; 7.1" (18.0 cm), Vol. 0.85 mL, 1 Catheter Extension Set with injection site and Male Luer Lock adapter with retractable collar, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 2N8221. Recall # Z-0355-2011;

6) Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.57 mL, 1 Catheter Extension Set with luer activated valve for IV Access and Male Luer Lock adapter, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Made in Costa Rica; catalog 2N8222. Recall # Z-0356-2011
CODE
1) Lot numbers R09L05048, R09L08018, R09L08125, R09L17076, R09L17258 and R10A26142;
2) Lot numbers R10A30052 and R10B13049;
3) Lot numbers R10A20137, R10A21101 and R10B05052;
4) Lot numbers: R10B01119 and R10B17081;
5) Lot numbers: R10A25110;
6) Lot number: R10B01028
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 17, 2010.
Manufacturer: Baxter Productos Medicos Ltda., Parque Industrial - De Cartago, Cartago, Costa Rica. Firm initiated recall is ongoing.
REASON
The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. The device is labeled as nonpyrogenic.
VOLUME OF PRODUCT IN COMMERCE
172,300 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Detachol adhesive remover, 4 fl oz (118 mL). Recall # Z-0413-2011
CODE
Lot numbers: 09216B, 09218A, 09219A, 09231A, 09232A, 10003A, and 10004A
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, MI, by letter dated July 7, 2010. Firm initiated recall is ongoing.
REASON
There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.
VOLUME OF PRODUCT IN COMMERCE
Approximately 55,000 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Batch # Bt017170. Recall # Z-0427-2011
CODE
Lot number: BC071710
RECALLING FIRM/MANUFACTURER
Preservation Solutions Inc., Elkhorn, WI, by letter dated October 18, 2010. Firm initiated recall is ongoing.
REASON
Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
CA, MO, PA
___________________________________
PRODUCT
Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum. Recall # Z-0711-2011
CODE
Lot 37772 Exp. Date: May 2011
RECALLING FIRM/MANUFACTURER
Diagnostic Chemicals, Ltd., Charlottetown Prince Edward Island, Canada, by letter dated November 10, 2010. Firm initiated recall is ongoing.
REASON
Cholesterol Reagent bottles labels reversed for R1 and R2.
VOLUME OF PRODUCT IN COMMERCE
30 kits
DISTRIBUTION
KY, PA, NV, and WA and Canada

RECALLS AND FIELD CORRECTIONS:  VETERINARY – CLASS I    
___________________________________
PRODUCT
Kent 20 Lamb DQ45, Active Drug Ingredient Decoquinate. Recall # V-096-2011
CODE
Lot # 810127
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kent Nutrition Group Inc., Muscatine, IA, by telephone on May 18, 2010 and press release on June 2, 2010.
Manufacturer: Kent Feeds Inc., Logansport, IN. Firm initiated recall is ongoing.
REASON
Recall is due to the discovery of excess amounts of copper in the feed of lot #810127.
VOLUME OF PRODUCT IN COMMERCE
231 bags
DISTRIBUTION
IN, OH

END OF ENFORCEMENT REPORT FOR FEBRUARY 2, 2011

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