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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 23, 2011

February 23, 2011                                                                                        11-08

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Jays Original Potato Chips, 12 oz bag, UPC #041200 097865. Recall # F-0444-2011
CODE
Jan 16 CA 54 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Snyders of Hanover, Inc., Hanover, PA, by press release, telephone and e-mail on November 19, 2010.
Manufacturer: Krunchers, Inc., Jeffersonville, IN. Firm initiated recall is ongoing.
REASON
Product contains undeclared Milk Allergen.
VOLUME OF PRODUCT IN COMMERCE
18 cases 0f 10 bags
DISTRIBUTION
IN, IL, MI, OH, WI
___________________________________
PRODUCT
1) Publix Bakery***Coconut Macaroons Coquitos, Net wt. 21 oz (1 lb 5 oz) 595g. UPC 41415-95290, Coconut Macaroons (Coquitos): Ingredients: Desiccated Coconut (Contains Sulfites), Sugar, Egg White, Water, Bleached Wheat Flour (Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid), Corn Syrup, Cornstarch, Artificial Coconut Flavor. Contains Egg and Wheat Ingredients. Processed on Equipment that also Processes Milk. Recall # F-0445-2011;

2) ) Publix Bakery***Mini Coconut Macaroons with Chocolate Chips, Mini Coquitos Con Pedazos De Chocolate, Net wt 12 oz (340 g). Ingredients: Desiccated Coconut (Contains Sulfites), Sugar, Egg White, Water, Bleached Wheat Flour (Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid), Corn Syrup, Chocolate Chips (sugar, Partially Hydrogenated Cottonseed or Soybean Oil, Cocoa Powder, Corn Starch, Corn Syrup, Soy Lecithin, Salt and Artificial Flavor) Corn Starch, Artificial Coconut Flavor. UPC 10878 90012. Contains Egg and Wheat Ingredients. Processed on Equipment that also Processes Milk. Recall # F-0446-2011;

3) Publix Bakery***Mini Coconut Macaroons Mini Coquitos, Net wt 12 oz (340 g), UPC 10878-90011. Mini Coconut Macaroons (Mini Coquitos): Ingredients: Desiccated Coconuts (contains Sulfites),Sugar, Egg White, Water, Bleached Wheat Flour (Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid), Corn Syrup, Cornstarch, Artificial Coconut Flavor. Contains Egg and Wheat Ingredients. Processed on Equipment that also Processes Milk. Recall # F-0447-2011

4) Publix Bakery***Mini Coconut Macaroons with Confetti Sprinkles, Mini Coquitos con dulcecitos de colores, Net wt. 12 oz (340g) UPC 10878-90013. Mini Coconut Macaroons with Confetti Sprinkles (Mini Coquitos con dulcecitos de colores): Ingredients: Desiccated Coconuts (contains Sulfites), Sugar, Egg White, Water, Bleached Wheat Flour (Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid), Corn Syrup, Rainbow Sprinkles, (Sugar, Vegetable Shortening Partially Hydrogenated Cottonseed Oil or Soybean Oil, Corn starch, Corn Syrup, Dextrin, Lecithin, Salt Vanilla Flavor, Confectioners Glaze, FD&C Artificial colors yellow #5, yellow #6, red #40, blue #1) Cornstarch, Artificial Coconut Flavor. Contains Egg and Wheat Ingredients. Processed on equipment that also processes milk. Recall # F-0448-2011
CODE
1) All Lots: 121310 Exp. 3/13/11; 121410 Exp 3/14/11; 121510 Exp 3/15/11;
2) All Lots Number: 120110,
3) All Lot Numbers: 121410 Exp 1/14/11; 121510 Exp. 1/15/11);
4) All lots 120110, Exp 1/01/11
RECALLING FIRM/MANUFACTURER
South Florida Bakery, Inc., Miami, FL, by telephone on December 22, 2010. Firm initiated recall is ongoing.
REASON
Ingredient labeling does not declare the presence of Whey a sub-ingredient.
VOLUME OF PRODUCT IN COMMERCE
394 cases
DISTRIBUTION
FL, GA
___________________________________
PRODUCT
Better Made Special Since 1930, Corn Pops, No Hulls! No Hard Kernels!, Net wt. 8 oz. (227g), Delicious Caramel Corn Recipe on Back, UPC code 041633-003716. Recall # F-0449-2011
CODE
Expiration code of MAR1411
RECALLING FIRM/MANUFACTURER
Pretzels, Inc., Bluffton, IN, by telephone beginning January 19, 2011. Firm initiated recall is ongoing.
REASON
Product may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
869 cases (8/8-ounces bags per case)
DISTRIBUTION
MI
___________________________________
PRODUCT
Tomaso's Classic Caesar dressing; 12 fl oz. (355 ml); Perishable - Refrigerate. UPC 48535 10205. Recall # F-0450-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Tomaso's Specialty Foods, Blue Lake, CA, by press release on January 31, 2011. FDA initiated recall is ongoing.
REASON
Undeclared Allergan - ingredients include mayonnaise which contains eggs; eggs not declared on labeling.
VOLUME OF PRODUCT IN COMMERCE
602 x 12 oz bottles
DISTRIBUTION
Humboldt County, CA
___________________________________
PRODUCT
Cuernos, Plain (croissant). Product is sold in packages of 3 or 4 cuernos. Ingredients: Flour, Water, Eggs, Vegetable shortening, margarine, sugar, salt. Recall # F-0451-2011.
CODE
All lots manufactured beginning 06/27/2010 (or LOT 100627)
RECALLING FIRM/MANUFACTURER
Mexicantown Wholesale, Detroit, MI, by telephone and press release on December 30, 2011. FDA initiated recall is ongoing.
REASON
The finished product contains undeclared milk, yellow #5, and wheat.
VOLUME OF PRODUCT IN COMMERCE
246 four-packs; 33 three-packs
DISTRIBUTION
MI, Canada
___________________________________
PRODUCT
Ossies Schmaltz Herring is packed in a 12 oz semi-clear plastic tub with a white color snap lid. Recall # F-0452-2011
CODE
Date code "2/0311"
RECALLING FIRM/MANUFACTURER
MS Fish Corp., Brooklyn, NY, by press release on January 12, 2011. New York initiated recall is ongoing.
REASON
After routine sampling by the New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel found the product to be positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
100 lbs
DISTRIBUTION
NY State
___________________________________
PRODUCT
1) Mrs. Friday's Breaded Italian Calamari Ringers, 6/2 lb, SKU# 041210, Item number: 041210, UPC: 10070017412100. Recall # F-0453-2011;

2) Mrs. Friday's Breaded Italian Seasoned Calamari Rings, 6/ 32 oz, 907g, SKU# 041211, (for Canadian market). Item number: 41211 (Canadian). Recall # F-0454-2011;

3) Mrs. Friday's Italian Calamari Rings, 4/2.5 lb, SKU# 057800, Item number: 057800, UPC 10041338578004. Recall # F-0455-2011;

4) Mrs. Friday's Breaded Calamari Rings, 4/2 lb 8 oz (1.13kg), SKU# 057802. Item number: 057802, UPC 10041338578028. Recall # F-0456-2011
CODE
All date codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: King & Prince Seafood, Brunswick, GA, by letters on January 14, 2010 and January 21, 2010 and by press release on January 20, 2011.
Manufacturer: Shantou Longfeng Foodstuff Co., Ltd., Guangdong, China, Shantou, China. Firm initiated recall is ongoing.
REASON
Undeclared peanut protein.
VOLUME OF PRODUCT IN COMMERCE
28,301 cases (2 lb and 2.5 lb pkgs per case)
DISTRIBUTION
CA, FL, IL, IN, NY, TX, UT and Canada

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) American Spoon Apple Chipotle Sala, 13.5 oz jar, UPC Code 019363016047. Recall # F-0440-2011;

2) American Spoon brand Maple BBQ Grilling Sauce, Michigan maple mingled with tomatoes & spices, 15 oz jar, UPC Code 019363014371. Recall # F-0441-2011;

3) American Spoon brand Pumpkin Chipotle Roasting Sauce, Rich pumpkin melded with smoky chipotle & subtle spice, 14 oz jar, UPC Code 019363014173. Recall # F-0442-2011
CODE
1), 2) and 3) Lot codes from 9301 - 9363; 0002 - 0365; and 1002 - 1034
RECALLING FIRM/MANUFACTURER
American Spoon Foods, Inc., Petoskey, MI, by press release on February 3, 2011. Firm initiated recall is ongoing.
REASON
The products may contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
21,882 jars
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Western Family Sweet Relish, 24 Fl. oz., packaged in a glass jar UPC 15400 01598; Product of India; Nutrition Facts Serving Size: 1 Tbsp (15 g); Servings per Container: about 47. Recall # F-0443-2011
CODE
Lot #91850V, Best by Dec 22, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Global Green USA Ltd., Ramsey, NJ, by telephone and letters dated December 24, 2010.
Manufacturer: The Global Green Co. Ltd-Unit Venkatapur, Medak District, India. Firm initiated recall is ongoing.
REASON
Sweet relish may contain glass pieces.
VOLUME OF PRODUCT IN COMMERCE
7,224 jars
DISTRIBUTION
OR
___________________________________
PRODUCT
1) 1. Multi-colored bag with multi-colored print. Barcel Takis Fuego Hot chili pepper & lime flavored corn snack. Net wt 4 oz (113.4g). UPC#074323027532. 16 bags/case; 2. Multi-colored bag with multi-colored print. Barcel Takis Fuego Hot chili pepper & lime flavored corn snack. Net wt 9.87 oz (280g). UPC#074323078190. 12 bags/case; 3. Multi-colored bag with multi-colored print. Barcel mini Takis Fuego, Hot chili pepper & lime flavored corn snack. Net wt 1.23 oz (35g). UPC#074323075083. 25 bags/container. 5 containers/case. 125 bags total/case. Recall # F-0457-2011;

2) Multi-colored bag with multi-colored print. Barcel Takis Guacamole, Guacamole Flavored Rolled Corn Tortilla Minis. Net wt 4 oz (113.4g). UPC#074323031591. 16 bags/case. Recall # F-0458-2011;

3) 1. Multi-colored bag with multi-colored print. Barcel Takis Salsa Brava, Hot sauce flavored corn snack. Net wt 4 oz(113.4g). UPC#074323033465. 16 bags/case; 2. Multi-colored bag with multi-colored print. Barcel Takis Salsa Brava, Hot sauce flavored corn snack. Net wt 9.87 oz (280g). UPC#074323033519. 12 bags/case. Recall # F-0459-2011;

4) 1. Multi-colored bag with multi-colored print. Barcel Takis Crunchy Fajita, Taco Flavored Rolled Corn Tortilla Minis. Net wt 4 oz (113.4g). UPC #074323078336. 16 bags/case; 2. Multi-colored bag with multi-colored print. Barcel Takis Crunchy Fajita, Taco Flavored Rolled Corn Tortilla Minis. Net wt 9.87 oz (280g). PC #074323096323. 12 bags/case. Recall # F-0460-2011;

5) 1. Multi-colored bag with multi-colored print. Barcel Takis Nitro Habanero & lime flavored corn snack. Net wt 3.98 oz (113g). UPC#757528003111. 16 bags/case; 2. Multi-colored bag with multi-colored print. Barcel Takis Nitro Habanero & lime flavored corn snack. Net wt 9.85 oz (280g). UPC#757528003180. 12 bags/case. Recall # F-0461-2011
CODE
1) 1. MAR0211N, MAR2311N, MAR3011N, APR0611N, APR1311N, APR2011N, APR2611N; 2. MAR0211N, MAR2311N, MAR3011N, APR0611N, APR1311N, APR2011N; 3. JAN1911N, FEB1611N, FEB2311N, MAR0211N, MAR0911N;

2) MAR2311N, MAR3011N, APR2011N;

3) 1. MAR3011N, APR1311N, APR2011N; 2. MAR3011N, APR1311N, APR2011N;

4) 1. MAR0211N, MAR3011N, APR0611N, APR1311N, APR2011N; 2. MAR0211N, MAR3011N, APR0611N, APR1311N, APR2011N;

5) 1. JAN1911N, FEB1611N, MAR0211N, MAR0911N, APR2011N; 2. JAN1911N, FEB1611N, MAR0211N, MAR0911N, APR2011N
RECALLING FIRM/MANUFACTURER
Barcel USA, LLC, Irving, TX, by letter on January 6, 2011. Tennessee initiated recall is ongoing.   
REASON
Variety of Barcel Corn Products possibly contaminated with Aflatoxins.
VOLUME OF PRODUCT IN COMMERCE
615,628 Cases (10,609,728 Bags)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Vinegar and Salt Potato Chips, in white bag with black lettering, 11 oz, 8 bags are packaged in a brown cardboard case, UPC 1193100008. Recall # F-0462-2011
CODE
NOV 23 and NOV 29
RECALLING FIRM/MANUFACTURER
Downeys Potato Chips Waterford, Waterford, MI, by telephone, e-mail and visits on October 29, 2010. FDA initiated recall is ongoing.
REASON
Product contains milk that is not declared on the label. Ingredients statement lists lactose but not milk.
VOLUME OF PRODUCT IN COMMERCE
240 bags
DISTRIBUTION
MI
___________________________________
PRODUCT
Apple cider in 1/2 gallon and 1 gallon plastic containers. UPC codes: 2290600128, 2290600064. Recall # F-0463-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Bauman Orchards Inc., Rittman, OH,  by press release, e-mail, fax and telephone on December 2, 2010. Firm initiated recall is ongoing.
REASON
The recall is being conducted as a precautionary measure because the apple cider was under processed.
VOLUME OF PRODUCT IN COMMERCE
300 gallons
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Tomi Dried Baby Squid - 8 oz - UPC 00000070187. Recall # F-0465-2011;
2) Tomi Dried Golden Threadfin Beam- 8 oz - UPC 79598107170. Recall # F-0466-2011;
3) Tomi Dried Indian Mackerel - 8 oz - UPC 79598107166. Recall # F-0467-2011;
4) Tomi Dried Trevally - 8 oz - UPC 79598107164. Recall # F-0468-2011;
5) Tomi Dried Shrimp Fry - 4 oz - UPC 00000079922. Recall # F-0469-2011;
6) Dried Anchovy (Kien Long) - 3.5 oz - UPC 893509680073. Recall # F-0470-2011;
7) Tomi Dried Round Scad - 8 oz - UPC 79598107173. Recall F-0471-2011;
8) Tomi Dried Mullet Kapak - 8 oz - UPC 79598107179. Recall # F-0472-2011;
9) Tomi Dried Tuyo Herring - 4 oz - UPC 79598107175. Recall # F-0473-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Foremost Foods Corp., Pomona, CA, by e-mail and visit on October 15, 2010.
Manufacturer: Kien Long Seafood Company Ltd, Rach Gia City, Vietnam. FDA initiated recall is ongoing.
REASON
Imported seafood products were not processed in accordance with U.S. FDA food manufacturing standards.
VOLUME OF PRODUCT IN COMMERCE
76,160 packages
DISTRIBUTION
CA, NV, WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Labeling in part " Landmark Raw Milk Cheese Goat Cheddar ***Raw Milk Goat Cheddar Cheese**". 7 oz. to 9 oz. net weight package. Item code number 111126. Recall # F-0464-2011
CODE
Sell By Date: June 22, 2010
RECALLING FIRM/MANUFACTURER
Rumiano Cheese Co., Willows, CA, by letter dated March 1, 2010. Firm initiated recall is complete.
REASON
Mislabeled product, distributed.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA, WA, OR, HI

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
ArimaDex Dietary Supplement Capsules, 442 mg proprietary blend including 3, 17-keto-etiochol-triene, supplied in 60 count bottles, UPC 718122 466511. Recall # D-253-2011
CODE
Lot No. S9H042 - Exp: 09/22/11; Lot No. S9A102 - Exp: 02/24/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genetic Edge Technologies, Phoenix, AZ, by telephone on September 13, 2010 and by press release on September 14, 2010.  
Manufacturer: Watson Industries Inc., Pomona, CA. FDA initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA; product has been found to contain 3, 17-keto-etiochol-triene, a synonym for the same ingredient, commonly known as ATD. ATD is an aromatase inhibitor not considered a dietary ingredient
VOLUME OF PRODUCT IN COMMERCE
13,686 bottles (279 bottles in house at time of recall)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Refenesen Expectorant (guaifenesin) Tablets, 200 mg, 60-count bottle, NDC 10956-752-60; also labeled as: Leader Cough Tabs Expectorant, NDC 37205-466-72; Quality Choice Medifin, NDC 63868-754-60; and Select Brand Mucus Relief Expectorant, NDC 15127-129-60. Recall # D-254-2011
CODE
Lot #091612, Exp 05/11 with markings of SS/SCT36 06/26/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reese Pharmaceutical Co., Cleveland, OH, by letters on November 3, 2010 and by press release on December 9, 2010.
Manufacturer: Contract Pharmacal Corp., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-Up; some bottles labeled to contain Guaifenesin 200 mg tablets may actually contain Acetaminophen 325 mg, Phenylephrine 5 mg and Chlorpheniramine Maleate 2 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
337 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Bravelle (urofollitropin for injection, purified), Q.Cap, 75 IU, 5 single-dose vials, For Subcutaneous and Intramuscular Injection only, Rx only, NDC 55566-8505-6. Recall # D-252-2011  
CODE
Bravelle Vial Lot #: 0E534, Exp 7/12 Bravelle Q-cap carton Lot #: 0E534A-1, Exp 02/12 Incorrect Menopur inner cartons within the Bravelle Q-cap cartons Lot#: 0E534A, Exp 2/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by telephone on January 7, 2011 and by letters on January 19, 2011.
Manufacturer: Draxis Specialty Pharmaceutical Inc., Kirkland Quebec, Canada. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-Up; Ferring received a product complaint indicating that several sale units of Bravelle contained inner cartons mis-labeled as Menopur. Menopur is also a Ferring infertility product. The Menopur cartons were imprinted with the correct lot number for the inner carton assembly of Bravelle, and were noted to contain the correct lot of Bravelle vials.
VOLUME OF PRODUCT IN COMMERCE
6,434 Q-Cap cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Fluticasone Propionate Ointment, 0.005%, 15 mg, Rx only, NDC 0168-0333-15. Recall # D-251-2011
CODE
Batch number: 790G, Exp: 10/11
RECALLING FIRM/MANUFACTURER
Nycomed US Inc., Hicksville, NY, by letter on January 6, 2011. Firm initiated recall is ongoing.
REASON
Stability Data does not Support Expiration Date: Out of specification result for weight loss for one tube out of ten during routine stability testing at the 6month time point.
VOLUME OF PRODUCT IN COMMERCE
5,148 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-0352-11
CODE
Units: BQ084024, BQ083881
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Owensboro, KY, by facsimile on October 26, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0713-11
CODE
Unit: 53LF11060
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD by telephone on November 17, 2010. Firm initiated recall is compete.
REASON
Blood product, collected using equipment that had not been validated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0736-11
CODE
Unit: W047010702896
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by letter on December 9, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0766-11
CODE
Unit: W088910203657
RECALLING FIRM/MANUFACTURER
Scott & White Memorial Hospital and Scott, Sherwood & Brindley Foundation, Temple, TX by E-mail on December 6, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0773-11
CODE
Unit: 2547033
RECALLING FIRM/MANUFACTURER
Kentucky Blood Center Inc., Lexington, KY, by letter dated December 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Level I® Normothermic IV Fluid Administration Sets, Product Code D-60HL and Product Code DI-60HL (sold outside the U.S. and Canada) Disposable Sets" are single patient use Sets designed for use by trained medical professionals, in conjunction with Level I® H-IOOO, H-I025, H-I028, and H-1200 Fast Flow Fluid Warmers ("Fluid Warmer"), Recall # B-0782-11
CODE
Lot Numbers: D-60HL: 1208297, 1212856, 1212857, 1215601, 1221992, 1221998, 1224514, 1247148, 1269236, 1273859, 1273882, 1334930, 1333949, 1351743, 1357674, 1273859, 1334930, 1333949, 1351743, 1357674 DI-60HL: 1202019, 1202020, 1202021, 1202022, 1202023, 1212858, 1212859, 1212860, 1215578, 1215579, 1215580, 1222004, 1222005, 1222006, 1224524, 1224525, 1224526, 1224527, 1224528, 1224529, 1224530, 1224533, 1224534, 1224535, 1224536, 1224532, 1224531, 1224537, 1224538, 1254334, 1254332, 1243235, 1243223, 1273868, 1273878, 1273871, 1273872, 1273869, 1273870, 1273874
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter on September 29, 2010 and corrected letter dated October 8, 2010. Firm initiated recall is complete.  
REASON
Level I® Normothermic IV Fluid Administration Sets, which may be too long and not fit into Level l® Fast Flow Fluid Warmers causing delay of treatment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
76,112 units
DISTRIBUTION
Nationwide, Canada, Italy, Sweden, Germany, Spain, France, Saudi Arabia, Portugal, Poland, Czech Republic, Denmark, Great Britain, Chile, Kuwait, Brazil, China, Singapore, Ecuador, Columbia, Greece, Bulgaria, Norway, Slovakia, United Arab Emirates, Australia, Romania, Finland, Thailand, Estonia, Japan
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0831-11;
2) Recovered Plasma. Recall # B-0832-11
CODE
1) and 2) Units: W117009121853, W117009193312, W117009177629
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by letter dated November 3, 2010 and by facsimile on November 3, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0833-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0834-11
CODE
1) Unit: W037710502153;
2) Units: W037710032197, W037710011296, W037709080965
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letters dated August 18, 2010 and October 11, 2010. 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
4 units
 

DISTRIBUTION
FL, KY, OH

___________________________________
PRODUCT
Red Blood Cells. Recall # B-0835-11
CODE
Unit: W035410061172
RECALLING FIRM/MANUFACTURER
Community Blood Center dba Community Tissue Services, Dayton, OH, by letter dated November 30, 2010 and by telephone on December 29, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0836-11
CODE
Unit: 032FF45448
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on October 5, 2010 and by letter dated October 15, 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
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0837-11
CODE
Unit: 032KT92451 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on October 29, 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
MA, PA
___________________________________
PRODUCT
Source Plasma. Recall # B-0846-11
CODE
Unit: 09MMNE8179
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, electronically on December 3, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0859-1
CODE
Units: 1313963; 1277413; 1091555; 1052157; 0918856; 0835000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letters dated November 24, 2010 and January 10, 2011 and through the EDN notification system on November 15, 2010.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN Firm initiated recall is complete.
REASON   
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 Units
DISTRIBUTION
PA, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0861-11
CODE
Unit: 53J37595
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by fax on November 13, 2010. Firm initiated the recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.,            
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0875-11
CODE
Unit: W038110123236
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers - Lake Park, Lake Park, FL, by letter on September 3, 2010 and a second attempt on December 2, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0880-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0881-11
CODE
1) and 2) Unit: W038110247334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by telephone on October 11, 2010 and letter on October 12, 2010.
Manufacturer: Florida's Blood Centers, Inc., Kissimmee, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0882-11
CODE
Unit: W067310000662
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc, Amarillo, TX, by letter dated June 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0883-11
CODE
Units: W045010074696, W045009004367, W045008033538
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater KC, Kansas City, MO, by facsimile on November 23, 2010 and by letter dated November 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, MO, KA, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0885-11
CODE
Units: W038110203801, W038110127217
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Ormond Beach, FL, by telephone on November 5, 2010 and by letter dated November 5, 2010. 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
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0886-11
CODE
Unit: W035211003791R
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX by e-mail on December 27, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving disqualifying information from the donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0889-11
CODE
Unit:  W038110243142
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Ormond Beach, FL, by letter on October 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0890-11
CODE
Unit: W120610252097
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on December 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0891-11;
2) Red Blood Cells. Recall # B-0892-11
CODE
1) and 2) Unit: W038110265201
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated December 9, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported post donation information regarding a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
France, FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0895-11
CODE
Unit: W120610323120
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by fax on December 28, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0896-11
CODE
Unit: 55FS49101
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by fax and LOGIC on December 5, 2010 and follow up letter on January 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL, MO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0898-11
CODE
Unit: W120610012523
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by fax on November 26, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0899-11;
2) Red Blood Cells. Recall # B-0900-11
CODE
1) Unit: W038509302089;
2) Units: W038509302089; 3036604
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on December 16, 2010 and December 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Israel, GA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0902-11;
2) Fresh Frozen Plasma. Recall # B-0903-11;
3) Platelets. Recall # B-0904-11
CODE
1) and 2) Units: 4028905; 3124284;
3) Unit: 3124284
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on December 7, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0905-11
CODE
W120610015206; W120610015206 (split product)
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by fax on November 26, 2010. Firm initiated recall is complete.
REASON
Blood Products, collected in an apheresis collection kit which was not used within an acceptable time period, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0906-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0907-11
CODE
1) and 2) Unit: 27C13113
RECALLING FIRM/MANUFACTURER
American Red Cross Greater Alleghenies Region, Johnstown, PA, by telephone on November 3, 2010 and follow up letter dated November 20, 2010.
REASON
Blood products, collected from donor who was previously deferred due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV, PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0908-11
CODE
Unit: W115111012158I
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on December 17, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0910-11
CODE
Unit: W051710504082
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone on December 2, 2010. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Source Plasma. Recall # B-0911-11
CODE
Unit: 09SPAB1925
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Lp, State College, PA, electronically by shared database on December 15, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0916-11
CODE
Unit: 2534292
RECALLING FIRM/MANUFACTURER
Kentucky Blood Center Inc., Lexington, KY, by letter dated January 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0917-11
CODE
Unit: W044410602383
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by letter dated December 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0918-11
CODE
Units: W043810304355 (2 units), W043810304491 (2 units), W043810304891, W043810305637 (2 units), W043810306005 (2 units), W043810306143 (2 units), W043810307044 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated January 12, 2011. 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
13 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0830-11
CODE
Unit: W044410204258
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by telephone on December 14, 2010 and by letter dated December 27, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0860-11
CODE
Units: 1313963; 1277413; 1091555; 1052157; 0918856; 0835000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letters dated November 24, 2010 and January 10, 2011 and through the EDN notification system on November 15, 2010.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN Firm initiated recall is complete.
REASON   
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 Units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0862-11
CODE
Unit: 53J37595
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, via the Logic computer system on November 13, 2010. Firm initiated the recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0865-11
CODE
Unit: W036210843792
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on November 1, 2010 and fax on November 5, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0884-11
CODE
Units: W045010074696, W045009004367, W045008033538
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater KC, Kansas City, MO, by facsimile on November 23, 2010 and by letter dated November 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, MO, KA, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0887-11
CODE
Units: W127810105918, W127810403725
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on December 1, 2010 and by letters dated December 1, 2010 and December 2, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0897-11
CODE
Unit: 55FS49101
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by fax and LOGIC on December 5, 2010 and follow up letter on January 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL, MO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0901-11
CODE
Units: W038509302089; 3036604
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on December 16, 2010 and December 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Israel, GA

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
___________________________________
PRODUCT
1) ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses. Recall # Z-1068-2011;

2) FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses. Recall # Z-1069-2011
CODE
1) Lot Numbers: E4MJ47, E4MF6W, E4MK84, E4MM23, E4MM64, E4MP4A, E4MR15, E4MT07, E4MT4Y, F4MU2R, F4MY91, E4MG53, E4MG5K, E4MG5L, E4MN39, E4MG89, E4MG9M, E4MH2L, E4ML6J, E4MG77, E4MG8A, E4MH18, E4MJ3K, F4MX8C, and F4N799;

2) Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters dated April 7, 2009.
Manufacturer: Ethicon Endo-surgery, Inc. S.a. De C.v., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
The affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.
VOLUME OF PRODUCT IN COMMERCE
29,538 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy. Recall # Z-1223-2011
CODE
Units: SG33620363, US68537171, SG10821625, 3713G01281, SG03321319, SG33520213, US19502892, C160, SG0320704, SG44120295, 00000000000002, SG31630678, SG24820212, SG24820194, SG44221038, SG34620630, SG40920412, SG31020878, A4986A, SG11520160, SG44720158, SG41720310, SG43820213, 3416G09539, SG24820139, US19257221, SG33820630, 19476882, SG13320399H, SG40520126, SG50425261, SG41720317, US66320311, US19490144, SG21220130, US68154038, US19501776, SW ONLY, SG32520836, 3416G08464, SG21220113, SG44925638, SG04120289, SG51220179, SG2030679, US6824174, SG22920793, SG4820232, 3628G06513, 000000000000019, 00000000000004, US19310946, 3416G05185, US69131975, SG42520530, SG23320693, US68104248, SG23720396, SG24820231, SG14720637, SG43520759, US68513855, SG44820136, SG20220701, SG44120292, US19476874, US6863578, SG04020719, 3416G07810, SG43720660, SG44925635, US68538435, US19322820, SG33320960, US19319754, SG31620624, US10102906, SG44925637, SG43520477, US69172955, SG42720416, 3711C04231, US68154724, SG0620611, SG20220192, SG33620337, US19311023, SG35020182, US19239028, SG50425266, SG51920134, 000000000000011, SG44925633, SG24021335, 0304011939, A4986A, SG34220901, SG1220108, SG32120124, US69132547, SG43720550, US19476879, 6146A06124, SG41920535, 6412A00007, US68500234, US19322145, SG20220694, US68115508, SG41620718, SG10720353, 000000000000014, SG43520485, SG42820297, 000000000000015, SG41020267, US68104599, IE24488098, SG11421969, SG41720337, US6836799, US19344670, SG11720734, US68064889, SG20220679, 000000000000016, SG20220699, SG11421978, SG34220707, US19378673, SG34420200, SG20220143, SG50425271, US10025765, US90345020, US19345857, and SG13420315
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 2005 and November 22, 2005.
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is complete.
REASON
If a user accidentally selects the wrong image/tube position images can be displayed flipped.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00. Recall # Z-1225-2011;

2) Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN. Recall # Z-1226-2011;

3) Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195. Recall # Z-1227-2011;

4) Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. a) Contamination Sleeve part no. CON-006-02; b) Acuity Bleedback Control Valve part no. CSP-001-00; c) Acuity Rotating Hemostasis Valve part no. CSP-002-01; d) Acuity Universal Cutter part no. CSP-003-00; e) Acuity Universal Cutter part no. CSP-003-01. Recall # Z-1228-2011
CODE
1) Lot #S32364; Lot #S32528;

2) Lot #S33309; Lot #S33308;

3) Lot #S32071; Lot #S32067; Lot #S32830; Lot #S33028; Lot #S33050; Lot #S33628; Lot #S32206; and Lot No. S32546;

4) a) Lot no. S32943; b) lot no. Z0000040; c) lot no. Z0000036; d) lot numbers Z0000038 and Z0000039; e) lot number Z0000054
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc., Malvern, PA, by letter dated December 16, 2010. Firm initiated recall is ongoing.
REASON
Compromised sterility/weak or open seals.
VOLUME OF PRODUCT IN COMMERCE
28,679 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT
AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.. Recall # Z-1229-2011
CODE
All units
RECALLING FIRM/MANUFACTURER
AMS Innovative Center - San Jose, San Jose, CA, by letters via express mail on February 8, 2010, and September 15, 2010. Firm initiated recall is ongoing.
REASON
A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
VOLUME OF PRODUCT IN COMMERCE
242,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1. The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures. Z-1230-2011
CODE
Units: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 4ZK, 51K, 52K, 53K, 54K, 55K, 6XK, 6ZK, 71K, 72K, 73K, 74K, 75K, 76K, 77K, 78K, 79K, 7XK, 7YK, 7ZK, 81K, 82K, 83K, 84K, 85K, 86K, 87K, 87K, 88K, 89K, 8XK, 8YK, 8ZK, 91K, 95K, 96K, 97K, 99K, 9XK, 9YK and 9ZK
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated January 10, 2011. Firm initiated recall is ongoing.
REASON
The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has received 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the complaints were beyond their product life specification.
VOLUME OF PRODUCT IN COMMERCE
2,782 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Integra Peritoneal Introducer Sheaths, 61 cm; Integra NeuroSciences/REF 901-124; Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Recall # Z-1231-2011
CODE
Lot Number 162956 510 K - K771529
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated December 22, 2010.
Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing.
REASON
Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
VOLUME OF PRODUCT IN COMMERCE
95 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190021775. Recall # Z-1232-2011;

2) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190021991. Recall # Z-1233-2011;  

3) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190070031. Recall # Z-1234-2011;

4) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020775. Recall # Z-1235-2011;

5) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020991. Recall # Z-1236-2011;

6) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020105. Recall # Z-1237-2011;

7)  Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020060. Recall # Z-1238-2011;

8) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 519002012. Recall # Z-1239-2011;

9) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190020047. Recall # Z-1240-2011;   

10) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013160. Recall # Z-1241-2011;

11) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013150. Z-1242-2011;

12) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013140. Recall # Z-1243-201;

13) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013170. Recall # Z-1244-2011
CODE
1) Lot 9190017;  
2) Lot 9012017;
3) Lots 9183017, 9202017, 10104017;  
4) Lot 9216017;
5) Lots 9089017, 9183017, 10008017, 10173017;
6) Lots 9077017, 10155017;
7) Lot 9189017;
8) Lot 9197017;
9) Lot 9188017;
10) Lot 9021017;
11) Lot 9188017;
12) Lot 9188017;
13) Lot 9188017
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated December 2, 2010. 
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is complete.  
REASON
Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide, Sweden and Australia
___________________________________
PRODUCT
GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results. Recall # Z-1245-2011
CODE
Software versions 3.x and 4.x
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare IT, Barrington, IL, by letters dated December 12, 2010. 
Manufacturer: Triple G Systems Group, Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.
REASON
The GE Centricity Laboratory System Software has safety issues with the "Telephone List" function, the "Anatomic Pathology" application, and the Instrument Interface IO module that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide, and of Australia, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore
___________________________________
PRODUCT
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each. Recall # Z-1246-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho Organizers Inc., Carlsbad, CA, by letter, dated November 1, 2010.
Manufacturer: Ortho Solutions Lc Dyna Flex, Saint Ann, MO. Firm initiated recall is ongoing.
REASON
Products were mis-labeled as nickel free.
VOLUME OF PRODUCT IN COMMERCE
1,300 units
DISTRIBUTION
Nationwide, Canada, Belgium, Norway, and Columbia
___________________________________
PRODUCT
Mantis Tap Sleeve, packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN The Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted. Recall # Z-1247-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, letter dated January 07, 2011. 
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / PEI tube interface. This can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA. Recall # Z-1248-2011
CODE
Serial numbers: 1987591 - 09/2010, 1987597 - 09/2010, 1987598 - 09/2010, 1987599 - 09/2010 and 1987600 - 09/2010
RECALLING FIRM/MANUFACTURER
Gendex Dental Systems, Des Plaines, IL, by letter dated December 17, 2010. Firm initiated recall is completed.
REASON
The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX. Recall # Z-1249-2011
CODE
Units: H140001 H140038 H140074 H140111 H140146 H140227 H140721 H140756 H140791 H140826 H140002 H140039 H140075 H140112 H140147 H140228 H140722 H140757 H140792 H140827 H140003 H140040 H140076 H140113 H140148 H140229 H140723 H140758 H140793 H140828 H140004 H140041 H140077 H140114 H140149 H140230 H140724 H140759 H140794 H140829 H140005 H140042 H140078 H140115 H140150 H140231 H140725 H140760 H140795 H140830 H140006 H140043 H140079 H140116 H140151 H140232 H140726 H140761 H140796 H140831 H140007 H140044 H140080 H140117 H140152 H140233 H140727 H140762 H140797 H140832 H140008 H140045 H140082 H140118 H140153 H140234 H140728 H140763 H140798 H140833 H140009 H140046 H140083 H140119 H140154 H140235 H140729 H140764 H140799 H140834 H140010 H140047 H140084 H140120 H140201 H140236 H140730 H140765 H140800 H140835 H140011 H140048 H140085 H140121 H140202 H140237 H140731 H140766 H140801 H140836 H140012 H140049 H140086 H140122 H140203 H140238 H140732 H140767 H140802 H140837 H140014 H140050 H140087 H140123 H140204 H140239 H140733 H140768 H140803 H140838 H140015 H140051 H140088 H140124 H140205 H140240 H140734 H140769 H140804 H140839 H140016 H140052 H140089 H140125 H140206 H140700 H140735 H140770 H140805 H140840 H140017 H140053 H140090 H140126 H140207 H140701 H140736 H140771 H140806 H140841 H140018 H140054 H140091 H140127 H140208 H140702 H140737 H140772 H140807 H140842 H140019 H140055 H140092 H140128 H140209 H140703 H140738 H140773 H140808 H140843 H140021 H140056 H140093 H140129 H140210 H140704 H140739 H140774 H140809 H140844 H140022 H140057 H140094 H140130 H140211 H140705 H140740 H140775 H140810 H140845 H140023 H140058 H140095 H140131 H140212 H140706 H140741 H140776 H140811 H140846 H140024 H140060 H140096 H140132 H140213 H140707 H140742 H140777 H140812 H140847 H140025 H140061 H140097 H140133 H140214 H140708 H140743 H140778 H140813 H140848 H140026 H140062 H140098 H140134 H140215 H140709 H140744 H140779 H140814 H140849 H140027 H140063 H140099 H140135 H140216 H140710 H140745 H140780 H140815 H140850 H140028 H140064 H140100 H140136 H140217 H140711 H140746 H140781 H140816 H140851 H140029 H140065 H140101 H140137 H140218 H140712 H140747 H140782 H140817 H140852 H140030 H140066 H140102 H140138 H140219 H140713 H140748 H140783 H140818 H140853 H140031 H140067 H140103 H140139 H140220 H140714 H140749 H140784 H140819 H140854 H140032 H140068 H140105 H140140 H140221 H140715 H140750 H140785 H140820 H140855 H140033 H140069 H140106 H140141 H140222 H140716 H140751 H140786 H140821 H140856 H140034 H140070 H140107 H140142 H140223 H140717 H140752 H140787 H140822 H140857 H140035 H140071 H140108 H140143 H140224 H140718 H140753 H140788 H140823 H140858 H140036 H140072 H140109 H140144 H140225 H140719 H140754 H140789 H140824 H140859 H140037 H140073 H140110 H140145 H140226 H140720 H140755 H140790 H140825 H140861 H140862 H140864 H170078 H170251 H170413 H180040 H180117 H180193 H180256 H180319 H140863 H140865 H170080 H170255 H170414 H180043 H180119 H180195 H180257 H180321 H140864 H140866 H170084 H170258 H170418 H180044 H180120 H180197 H180258 H180322 H140865 H140867 H170089 H170262 H170422 H180045 H180122 H180199 H180260 H180323 H140866 H140868 H170093 H170264 H170428 H180046 H180124 H180201 H180262 H180324 H140867 H140869 H170097 H170268 H170430 H180048 H180128 H180203 H180264 H180325 H140868 H140871 H170100 H170269 H170432 H180049 H180129 H180204 H180265 H180326 H140869 H140872 H170109 H170275 H170436 H180050 H180131 H180206 H180266 H180327 H140871 H140873 H170126 H170291 H170438 H180052 H180132 H180208 H180267 H180328 H140872 H140874 H170127 H170292 H170439 H180053 H180133 H180209 H180268 H180329 H140873 H140875 H170130 H170299 H170441 H180056 H180135 H180210 H180270 H180330 H140874 H140876 H170131 H170301 H170443 H180058 H180136 H180214 H180271 H180401 H140875 H140877 H170133 H170302 H170445 H180059 H180138 H180215 H180272 H180402 H140876 H140878 H170137 H170311 H170458 H180061 H180143 H180217 H180273 H180403 H140877 H140881 H170138 H170314 H170460 H180062 H180144 H180218 H180274 H180404 H140878 H140882 H170142 H170315 H170461 H180065 H180147 H180220 H180275 H180405 H140881 H140883 H170147 H170316 H170462 H180066 H180148 H180221 H180277 H180406 H140882 H140886 H170149 H170319 H170468 H180067 H180151 H180222 H180283 H180407 H140883 H140887 H170161 H170321 H170469 H180069 H180154 H180224 H180284 H180409 H140886 H140889 H170166 H170329 H170473 H180073 H180156 H180225 H180285 H180410 H140887 H140891 H170169 H170331 H170477 H180075 H180157 H180226 H180287 H180411 H140889 H140892 H170171 H170332 H170479 H180077 H180158 H180228 H180289 H180412 H140891 H140893 H170175 H170336 H170481 H180079 H180159 H180229 H180290 H180413 H140892 H140895 H170182 H170342 H170482 H180080 H180160 H180230 H180291 H180414 H140893 H140896 H170192 H170343 H170704 H180082 H180161 H180232 H180292 H180415 H140895 H140897 H170195 H170344 H170732 H180083 H180164 H180233 H180293 H180417 H140896 H160009 H170198 H170356 H170749 H180087 H180166 H180235 H180294 H180419 H140897 H160610 H170201 H170360 H170787 H180088 H180167 H180236 H180295 H180420 H160009 H170004 H170207 H170363 H180001 H180089 H180168 H180237 H180296 H180421 H160610 H170012 H170210 H170366 H180003 H180093 H180170 H180238 H180298 H180422 H170004 H170025 H170213 H170367 H180004 H180098 H180171 H180239 H180299 H180424 H170012 H170028 H170216 H170377 H180007 H180099 H180173 H180240 H180303 H180425 H170025 H170030 H170218 H170380 H180008 H180102 H180175 H180242 H180304 H180426 H170028 H170035 H170219 H170382 H180016 H180103 H180178 H180243 H180305 H180427 H170030 H170038 H170220 H170388 H180017 H180104 H180179 H180245 H180307 H180429 H170035 H170042 H170226 H170393 H180019 H180106 H180180 H180246 H180310 H180430 H170038 H170048 H170232 H170396 H180020 H180107 H180181 H180248 H180311 H180432 H170042 H170051 H170233 H170400 H180025 H180108 H180182 H180249 H180312 H180433 H170048 H170053 H170235 H170402 H180026 H180110 H180185 H180250 H180314 H180436 H170051 H170071 H170238 H170403 H180028 H180113 H180186 H180251 H180315 H180437 H140862 H170072 H170245 H170408 H180030 H180115 H180188 H180254 H180317 H180440 H140863 H170073 H170248 H170412 H180034 H180116 H180192 H180255 H180318 H180441 H180442 H180486 H180540 H180583 H180627 H180670 H180714 H180757 H180801 H180843 H180443 H180487 H180541 H180584 H180628 H180671 H180715 H180758 H180802 H180844 H180444 H180489 H180542 H180585 H180629 H180672 H180716 H180759 H180803 H180845 H180445 H180490 H180543 H180586 H180630 H180673 H180717 H180760 H180804 H180846 H180446 H180491 H180544 H180587 H180631 H180674 H180718 H180761 H180805 H180847 H180447 H180492 H180545 H180588 H180632 H180675 H180719 H180762 H180806 H180848 H180448 H180493 H180546 H180590 H180633 H180676 H180720 H180763 H180807 H180849 H180449 H180494 H180547 H180591 H180634 H180678 H180721 H180764 H180808 H180850 H180450 H180495 H180548 H180592 H180635 H180679 H180722 H180765 H180809 H180851 H180451 H180496 H180549 H180593 H180636 H180680 H180723 H180766 H180810 H180852 H180452 H180498 H180550 H180594 H180637 H180681 H180724 H180767 H180811 H180853 H180453 H180499 H180551 H180595 H180638 H180682 H180725 H180768 H180812 H180854 H180454 H180502 H180552 H180596 H180639 H180683 H180726 H180769 H180813 H180855 H180455 H180505 H180553 H180597 H180640 H180684 H180727 H180770 H180814 H180856 H180456 H180507 H180554 H180598 H180641 H180685 H180728 H180771 H180815 H180857 H180457 H180508 H180555 H180599 H180642 H180686 H180729 H180772 H180816 H180858 H180458 H180509 H180556 H180600 H180643 H180687 H180730 H180773 H180817 H180859 H180459 H180510 H180557 H180601 H180644 H180688 H180731 H180774 H180818 H180860 H180460 H180511 H180558 H180602 H180645 H180689 H180733 H180775 H180819 H180861 H180461 H180512 H180559 H180603 H180646 H180690 H180734 H180776 H180820 H180862 H180462 H180513 H180560 H180604 H180647 H180691 H180735 H180777 H180821 H180863 H180463 H180514 H180561 H180605 H180648 H180692 H180736 H180778 H180822 H180864 H180464 H180515 H180562 H180606 H180649 H180693 H180737 H180779 H180823 H180865 H180466 H180518 H180563 H180607 H180650 H180694 H180738 H180780 H180824 H180866 H180467 H180519 H180564 H180608 H180651 H180695 H180739 H180781 H180825 H180867 H180468 H180520 H180565 H180610 H180652 H180696 H180740 H180782 H180826 H180868 H180469 H180521 H180567 H180611 H180653 H180697 H180741 H180783 H180827 H180869 H180470 H180522 H180568 H180612 H180654 H180698 H180742 H180784 H180828 H180870 H180471 H180524 H180569 H180613 H180655 H180699 H180743 H180785 H180829 H180871 H180472 H180525 H180570 H180614 H180656 H180700 H180744 H180786 H180830 H180872 H180473 H180527 H180571 H180615 H180657 H180701 H180745 H180787 H180831 H180873 H180474 H180528 H180572 H180616 H180658 H180702 H180746 H180788 H180832 H180874 H180475 H180529 H180573 H180617 H180659 H180703 H180747 H180790 H180833 H180875 H180476 H180530 H180574 H180618 H180660 H180704 H180748 H180791 H180834 H180876 H180477 H180531 H180575 H180619 H180661 H180705 H180749 H180792 H180835 H180877 H180478 H180532 H180576 H180620 H180662 H180706 H180750 H180793 H180836 H180878 H180479 H180533 H180577 H180621 H180663 H180707 H180751 H180794 H180837 H180879 H180480 H180534 H180578 H180622 H180664 H180708 H180752 H180795 H180838 H180880 H180482 H180535 H180579 H180623 H180665 H180709 H180753 H180796 H180839 H180881 H180483 H180536 H180580 H180624 H180667 H180710 H180754 H180798 H180840 H180882 H180484 H180538 H180581 H180625 H180668 H180711 H180755 H180799 H180841 H180883 H180485 H180539 H180582 H180626 H180669 H180713 H180756 H180800 H180842 H180884 H180885 H181023 H181066 H181112 H181160 H230161 H260902 H270047 H270235 H270323 H180886 H181024 H181067 H181113 H181161 H230162 H260905 H270060 H270237 H270324 H180887 H181025 H181068 H181114 H181162 H230175 H260909 H270068 H270240 H270328 H180888 H181026 H181069 H181115 H181163 H230184 H260915 H270073 H270242 H270329 H180889 H181027 H181070 H181116 H181164 H230197 H260916 H270074 H270244 H270332 H180890 H181028 H181071 H181117 H181165 H230198 H260917 H270075 H270245 H270335 H180891 H181029 H181072 H181118 H181166 H230203 H260922 H270079 H270251 H270336 H180892 H181030 H181073 H181119 H181167 H230204 H260923 H270084 H270252 H270337 H180893 H181031 H181074 H181120 H181168 H230215 H260924 H270088 H270254 H270338 H180894 H181032 H181075 H181123 H181170 H230217 H260926 H270094 H270255 H270341 H180895 H181033 H181076 H181124 H181171 H230220 H260928 H270096 H270256 H270342 H180896 H181034 H181077 H181125 H181173 H230222 H260930 H270101 H270260 H270343 H180897 H181035 H181078 H181126 H181175 H230224 H260931 H270106 H270261 H270344 H180898 H181036 H181079 H181127 H181176 H230231 H260932 H270107 H270264 H270345 H180899 H181037 H181080 H181128 H181177 H230233 H260933 H270109 H270267 H270346 H180901 H181038 H181082 H181129 H181179 H230237 H260936 H270110 H270270 H270349 H180904 H181039 H181083 H181132 H181180 H230240 H260938 H270111 H270271 H270351 H180906 H181040 H181084 H181133 H181181 H230242 H260939 H270116 H270273 H270352 H180907 H181041 H181085 H181134 H181185 H230245 H260940 H270118 H270274 H270353 H181000 H181042 H181086 H181135 H181187 H230248 H260942 H270123 H270277 H270355 H181001 H181043 H181087 H181136 H230002 H230249 H260944 H270126 H270280 H270356 H181002 H181044 H181088 H181137 H230007 H230252 H260946 H270128 H270281 H270360 H181003 H181045 H181089 H181138 H230008 H230254 H260947 H270134 H270282 H270361 H181004 H181046 H181090 H181139 H230034 H230255 H260948 H270136 H270284 H270364 H181005 H181047 H181091 H181140 H230035 H230256 H260949 H270138 H270285 H270365 H181006 H181048 H181092 H181141 H230039 H230258 H260950 H270141 H270288 H270370 H181007 H181049 H181093 H181142 H230057 H230263 H260951 H270143 H270290 H270371 H181008 H181050 H181094 H181143 H230062 H230265 H260952 H270144 H270293 H270373 H181009 H181051 H181095 H181145 H230064 H230268 H260953 H270201 H270297 H270375 H181010 H181052 H181096 H181146 H230067 H230270 H270001 H270209 H270299 H270377 H181011 H181053 H181097 H181147 H230071 H230271 H270004 H270211 H270300 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H272194 H272237 H272281 H272323 H272365 H272407 H272026 H272069 H272111 H272153 H272195 H272238 H272282 H272324 H272366 H272408 H272027 H272070 H272112 H272154 H272196 H272239 H272283 H272325 H272367 H272409 H272028 H272071 H272113 H272155 H272198 H272240 H272284 H272326 H272368 H272410 H272029 H272072 H272114 H272156 H272199 H272241 H272285 H272327 H272369 H272411 H272030 H272073 H272115 H272157 H272200 H272242 H272286 H272328 H272370 H272412 H272031 H272074 H272116 H272158 H272201 H272243 H272287 H272329 H272371 H272413 H272032 H272075 H272117 H272159 H272202 H272244 H272288 H272330 H272372 H272414 H272033 H272076 H272118 H272160 H272203 H272245 H272289 H272331 H272373 H272415 H272034 H272077 H272119 H272161 H272204 H272246 H272290 H272332 H272374 H272416 H272035 H272078 H272120 H272162 H272205 H272247 H272291 H272333 H272375 H272417 H272036 H272079 H272121 H272163 H272206 H272248 H272292 H272334 H272376 H272418 H272037 H272080 H272122 H272164 H272207 H272249 H272293 H272335 H272377 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H272907 H272950 H272992 H273036 H273078 H273121 H272433 H272477 H272822 H272865 H272908 H272951 H272993 H273037 H273079 H273122 H272434 H272478 H272823 H272866 H272909 H272952 H272994 H273038 H273080 H273123 H272435 H272479 H272824 H272867 H272910 H272953 H272995 H273039 H273081 H273124 H272436 H272480 H272825 H272868 H272911 H272954 H272996 H273040 H273082 H273125 H272437 H272482 H272826 H272869 H272912 H272955 H272997 H273041 H273083 H273126 H272438 H272483 H272827 H272870 H272913 H272956 H272998 H273042 H273084 H273127 H272439 H272484 H272828 H272871 H272914 H272957 H272999 H273043 H273085 H273128 H272440 H272485 H272829 H272872 H272915 H272958 H273000 H273044 H273086 H273130 H272441 H272488 H272830 H272873 H272916 H272959 H273001 H273045 H273087 H273131 H272442 H272489 H272831 H272875 H272917 H272960 H273002 H273046 H273088 H273132 H272443 H272490 H272833 H272876 H272918 H272961 H273003 H273047 H273089 H273133 H272444 H272491 H272834 H272877 H272919 H272962 H273004 H273048 H273090 H273134 H272445 H272492 H272835 H272878 H272920 H272963 H273005 H273049 H273091 H273135 H272446 H272493 H272836 H272879 H272921 H272964 H273006 H273050 H273092 H273136 H272447 H272494 H272837 H272880 H272922 H272965 H273007 H273051 H273093 H273137 H272448 H272495 H272838 H272881 H272923 H272966 H273008 H273052 H273094 H273138 H272449 H272496 H272839 H272882 H272924 H272967 H273010 H273053 H273095 H273139 H272450 H272497 H272840 H272883 H272925 H272968 H273011 H273054 H273097 H273140 H272451 H272498 H272841 H272884 H272926 H272969 H273012 H273055 H273098 H273141 H272452 H272500 H272842 H272885 H272927 H272970 H273013 H273056 H273099 H273142 H272453 H272800 H272843 H272886 H272928 H272971 H273014 H273057 H273100 H273143 H272454 H272801 H272844 H272887 H272929 H272972 H273016 H273058 H273101 H273144 H272455 H272802 H272845 H272888 H272930 H272973 H273017 H273059 H273102 H273145 H272456 H272803 H272846 H272889 H272931 H272974 H273018 H273060 H273103 H273146 H272457 H272804 H272847 H272890 H272932 H272975 H273019 H273061 H273104 H273147 H272458 H272805 H272848 H272891 H272933 H272976 H273020 H273062 H273105 H273148 H272460 H272806 H272849 H272892 H272934 H272977 H273021 H273063 H273106 H273149 H272461 H272807 H272850 H272893 H272935 H272978 H273022 H273064 H273107 H273150 H272462 H272808 H272851 H272894 H272936 H272979 H273023 H273065 H273108 H273151 H272463 H272809 H272852 H272895 H272937 H272980 H273024 H273066 H273109 H273152 H272464 H272810 H272853 H272896 H272938 H272981 H273025 H273067 H273110 H273153 H272465 H272811 H272854 H272897 H272939 H272982 H273026 H273068 H273111 H273155 H272466 H272812 H272855 H272898 H272940 H272983 H273027 H273069 H273112 H273156 H273157 H273200 H290118 H290182 H290225 H290269 H290316 H290358 H290400 H290518 H273158 H273201 H290119 H290183 H290226 H290271 H290317 H290359 H290401 H290519 H273159 H273202 H290121 H290185 H290227 H290272 H290318 H290360 H290402 H290520 H273160 H273203 H290122 H290186 H290228 H290273 H290319 H290361 H290403 H290521 H273162 H273204 H290123 H290187 H290229 H290274 H290320 H290362 H290404 H290522 H273163 H273205 H290125 H290188 H290230 H290275 H290321 H290363 H290405 H290523 H273164 H273206 H290128 H290189 H290231 H290276 H290322 H290364 H290406 H290524 H273165 H273208 H290130 H290190 H290232 H290277 H290323 H290365 H290407 H290525 H273166 H273209 H290131 H290191 H290233 H290278 H290324 H290366 H290408 H290526 H273167 H273210 H290132 H290192 H290234 H290279 H290325 H290367 H290409 H290527 H273168 H273528 H290135 H290193 H290235 H290280 H290326 H290368 H290410 H290528 H273169 H273547 H290137 H290194 H290236 H290281 H290327 H290369 H290411 H290529 H273170 H273578 H290138 H290195 H290237 H290282 H290328 H290370 H290412 H290530 H273171 H273711 H290139 H290196 H290239 H290283 H290329 H290371 H290413 H290531 H273172 H273929 H290141 H290197 H290240 H290284 H290330 H290372 H290414 H290532 H273173 H290001 H290142 H290198 H290241 H290285 H290331 H290373 H290415 H290533 H273174 H290002 H290143 H290199 H290242 H290286 H290332 H290374 H290416 H290534 H273175 H290003 H290144 H290200 H290243 H290287 H290333 H290375 H290417 H290535 H273176 H290012 H290145 H290201 H290244 H290288 H290334 H290376 H290422 H290536 H273177 H290016 H290146 H290202 H290245 H290289 H290335 H290377 H290423 H290537 H273178 H290017 H290149 H290203 H290246 H290290 H290336 H290378 H290424 H290538 H273179 H290021 H290151 H290204 H290247 H290291 H290337 H290379 H290425 H290539 H273180 H290026 H290152 H290205 H290248 H290292 H290338 H290380 H290426 H290540 H273181 H290027 H290154 H290206 H290249 H290293 H290339 H290381 H290427 H290541 H273182 H290030 H290155 H290207 H290250 H290295 H290340 H290382 H290500 H290542 H273183 H290031 H290156 H290208 H290251 H290296 H290341 H290383 H290501 H290543 H273184 H290032 H290157 H290209 H290253 H290297 H290342 H290384 H290502 H290544 H273185 H290033 H290158 H290210 H290254 H290299 H290343 H290385 H290503 H290545 H273186 H290034 H290160 H290211 H290255 H290301 H290344 H290386 H290504 H290546 H273187 H290100 H290161 H290212 H290256 H290302 H290345 H290387 H290505 H290547 H273188 H290103 H290162 H290213 H290257 H290304 H290346 H290388 H290506 H290548 H273189 H290104 H290164 H290214 H290258 H290305 H290347 H290389 H290507 H290549 H273190 H290105 H290165 H290215 H290259 H290306 H290348 H290390 H290508 H290550 H273191 H290106 H290166 H290216 H290260 H290307 H290349 H290391 H290509 H290551 H273192 H290108 H290168 H290217 H290261 H290308 H290350 H290392 H290510 H290552 H273193 H290109 H290171 H290218 H290262 H290309 H290351 H290393 H290511 H290553 H273194 H290110 H290173 H290219 H290263 H290310 H290352 H290394 H290512 H290554 H273195 H290111 H290175 H290220 H290264 H290311 H290353 H290395 H290513 H290555 H273196 H290113 H290176 H290221 H290265 H290312 H290354 H290396 H290514 H290556 H273197 H290114 H290177 H290222 H290266 H290313 H290355 H290397 H290515 H290557 H273198 H290116 H290180 H290223 H290267 H290314 H290356 H290398 H290516 H290558 H273199 H290117 H290181 H290224 H290268 H290315 H290357 H290399 H290517 H290559 H290560 H291040 H291082 H291126 H291168 H291210 H291252 H293317 H293360 H293403 H290561 H291041 H291083 H291127 H291169 H291211 H291253 H293318 H293361 H293404 H290600 H291042 H291084 H291128 H291170 H291212 H291254 H293319 H293362 H293405 H291001 H291043 H291085 H291129 H291171 H291213 H291255 H293320 H293363 H293406 H291002 H291044 H291086 H291130 H291172 H291214 H291256 H293321 H293364 H293407 H291003 H291045 H291087 H291131 H291173 H291215 H291257 H293322 H293365 H293408 H291004 H291046 H291088 H291132 H291174 H291216 H291258 H293323 H293366 H293409 H291005 H291047 H291089 H291133 H291175 H291217 H291259 H293324 H293367 H293410 H291006 H291048 H291090 H291134 H291176 H291218 H291260 H293325 H293368 H293411 H291007 H291049 H291091 H291135 H291177 H291219 H291261 H293326 H293369 H293412 H291008 H291050 H291092 H291136 H291178 H291220 H291262 H293327 H293370 H293413 H291009 H291051 H291093 H291137 H291179 H291221 H291263 H293328 H293371 H293414 H291010 H291052 H291094 H291138 H291180 H291222 H291264 H293329 H293372 H293415 H291011 H291053 H291095 H291139 H291181 H291223 H291265 H293330 H293373 H293416 H291012 H291054 H291096 H291140 H291182 H291224 H291266 H293331 H293374 H293417 H291013 H291055 H291097 H291141 H291183 H291225 H291267 H293332 H293375 H293418 H291014 H291056 H291098 H291142 H291184 H291226 H291268 H293333 H293376 H293419 H291015 H291057 H291099 H291143 H291185 H291227 H291269 H293334 H293377 H293420 H291016 H291058 H291101 H291144 H291186 H291228 H291270 H293335 H293378 H293421 H291017 H291059 H291102 H291145 H291187 H291229 H291271 H293336 H293379 H293422 H291018 H291060 H291103 H291146 H291188 H291230 H291272 H293337 H293380 H293423 H291019 H291061 H291104 H291147 H291189 H291231 H291273 H293339 H293381 H293424 H291020 H291062 H291105 H291148 H291190 H291232 H292832 H293340 H293382 H293425 H291021 H291063 H291106 H291149 H291191 H291233 H293009 H293341 H293383 H293426 H291022 H291064 H291107 H291150 H291192 H291234 H293207 H293342 H293384 H293427 H291023 H291065 H291108 H291151 H291193 H291235 H293300 H293343 H293385 H293428 H291024 H291066 H291109 H291152 H291194 H291236 H293301 H293344 H293386 H293429 H291025 H291067 H291111 H291153 H291195 H291237 H293302 H293345 H293387 H293430 H291026 H291068 H291112 H291154 H291196 H291238 H293303 H293346 H293388 H293431 H291027 H291069 H291113 H291155 H291197 H291239 H293304 H293347 H293389 H293432 H291028 H291070 H291114 H291156 H291198 H291240 H293305 H293348 H293390 H293433 H291029 H291071 H291115 H291157 H291199 H291241 H293306 H293349 H293391 H293434 H291030 H291072 H291116 H291158 H291200 H291242 H293307 H293350 H293392 H293435 H291031 H291073 H291117 H291159 H291201 H291243 H293308 H293351 H293393 H293436 H291032 H291074 H291118 H291160 H291202 H291244 H293309 H293352 H293394 H293437 H291033 H291075 H291119 H291161 H291203 H291245 H293310 H293353 H293395 H293438 H291034 H291076 H291120 H291162 H291204 H291246 H293311 H293354 H293396 H293439 H291035 H291077 H291121 H291163 H291205 H291247 H293312 H293355 H293397 H293440 H291036 H291078 H291122 H291164 H291206 H291248 H293313 H293356 H293398 H293441 H291037 H291079 H291123 H291165 H291207 H291249 H293314 H293357 H293399 H293442 H291038 H291080 H291124 H291166 H291208 H291250 H293315 H293358 H293401 H293443 H291039 H291081 H291125 H291167 H291209 H291251 H293316 H293359 H293402 H293444 H293445 H293487 H293531 H293574 H293618 H293660 H293703 H293748 H293792 H293836 H293446 H293488 H293532 H293575 H293619 H293661 H293704 H293749 H293793 H293837 H293447 H293489 H293533 H293576 H293620 H293662 H293705 H293750 H293794 H293838 H293448 H293490 H293534 H293577 H293621 H293663 H293706 H293751 H293795 H293839 H293449 H293491 H293535 H293578 H293622 H293664 H293707 H293752 H293796 H293840 H293450 H293492 H293536 H293579 H293623 H293665 H293708 H293753 H293797 H293841 H293451 H293493 H293537 H293581 H293624 H293666 H293709 H293754 H293798 H293842 H293452 H293494 H293538 H293583 H293625 H293667 H293710 H293755 H293799 H293843 H293453 H293495 H293539 H293584 H293626 H293668 H293712 H293756 H293800 H293844 H293454 H293496 H293540 H293585 H293627 H293669 H293713 H293758 H293801 H293845 H293455 H293497 H293541 H293586 H293628 H293670 H293714 H293759 H293802 H293846 H293456 H293498 H293542 H293587 H293629 H293671 H293715 H293760 H293803 H293847 H293457 H293499 H293543 H293588 H293630 H293672 H293716 H293761 H293804 H293848 H293458 H293500 H293544 H293589 H293631 H293673 H293717 H293762 H293805 H293849 H293459 H293501 H293545 H293590 H293632 H293674 H293718 H293763 H293806 H293850 H293460 H293502 H293546 H293591 H293633 H293675 H293719 H293764 H293807 H293851 H293461 H293503 H293548 H293592 H293634 H293676 H293720 H293765 H293808 H293852 H293462 H293504 H293549 H293593 H293635 H293677 H293721 H293766 H293809 H293853 H293463 H293505 H293550 H293594 H293636 H293678 H293723 H293767 H293812 H293854 H293464 H293506 H293551 H293595 H293637 H293679 H293724 H293769 H293813 H293855 H293465 H293507 H293552 H293596 H293638 H293681 H293725 H293770 H293814 H293856 H293466 H293508 H293553 H293597 H293639 H293682 H293726 H293771 H293815 H293857 H293467 H293509 H293554 H293598 H293640 H293683 H293727 H293772 H293816 H293858 H293468 H293510 H293555 H293599 H293641 H293684 H293728 H293773 H293817 H293859 H293469 H293511 H293556 H293600 H293642 H293685 H293729 H293774 H293818 H293860 H293470 H293512 H293557 H293601 H293643 H293686 H293730 H293775 H293819 H293861 H293471 H293513 H293558 H293602 H293644 H293687 H293732 H293776 H293820 H293862 H293472 H293514 H293559 H293603 H293645 H293688 H293733 H293777 H293821 H293863 H293473 H293515 H293560 H293604 H293646 H293689 H293734 H293778 H293822 H293864 H293474 H293516 H293561 H293605 H293647 H293690 H293735 H293779 H293823 H293865 H293475 H293517 H293562 H293606 H293648 H293691 H293736 H293780 H293824 H293866 H293476 H293518 H293563 H293607 H293649 H293692 H293737 H293781 H293825 H293867 H293477 H293519 H293564 H293608 H293650 H293693 H293738 H293782 H293826 H293868 H293478 H293520 H293565 H293609 H293651 H293694 H293739 H293783 H293827 H293869 H293479 H293521 H293566 H293610 H293652 H293695 H293740 H293784 H293828 H293870 H293480 H293522 H293567 H293611 H293653 H293696 H293741 H293785 H293829 H293871 H293481 H293523 H293568 H293612 H293654 H293697 H293742 H293786 H293830 H293872 H293482 H293524 H293569 H293613 H293655 H293698 H293743 H293787 H293831 H293873 H293483 H293525 H293570 H293614 H293656 H293699 H293744 H293788 H293832 H293874 H293484 H293527 H293571 H293615 H293657 H293700 H293745 H293789 H293833 H293875 H293485 H293529 H293572 H293616 H293658 H293701 H293746 H293790 H293834 H293876 H293486 H293530 H293573 H293617 H293659 H293702 H293747 H293791 H293835 H293877 H293878 H293920 H293965 H294008 H294051 H294093 H294137 H294181 H294223 H294268 H293879 H293921 H293966 H294009 H294052 H294094 H294140 H294182 H294224 H294269 H293880 H293922 H293967 H294010 H294053 H294095 H294141 H294183 H294225 H294270 H293881 H293923 H293968 H294011 H294054 H294097 H294142 H294184 H294226 H294271 H293882 H293924 H293969 H294012 H294055 H294098 H294143 H294185 H294227 H294272 H293883 H293925 H293970 H294013 H294056 H294099 H294144 H294186 H294228 H294273 H293884 H293926 H293971 H294014 H294057 H294100 H294145 H294187 H294229 H294274 H293885 H293928 H293972 H294015 H294058 H294101 H294146 H294188 H294230 H294275 H293886 H293929 H293974 H294016 H294059 H294102 H294147 H294189 H294231 H294276 H293887 H293930 H293975 H294017 H294060 H294103 H294148 H294190 H294232 H294277 H293888 H293931 H293976 H294018 H294061 H294104 H294149 H294191 H294233 H294278 H293889 H293932 H293977 H294020 H294062 H294105 H294150 H294192 H294234 H294279 H293890 H293933 H293978 H294021 H294063 H294106 H294151 H294193 H294235 H294280 H293891 H293934 H293979 H294022 H294064 H294107 H294152 H294194 H294236 H294281 H293892 H293935 H293980 H294023 H294065 H294108 H294153 H294195 H294237 H294282 H293893 H293936 H293981 H294024 H294066 H294109 H294154 H294196 H294238 H294283 H293894 H293937 H293982 H294025 H294067 H294110 H294155 H294197 H294239 H294284 H293895 H293938 H293983 H294026 H294068 H294111 H294156 H294198 H294240 H294285 H293896 H293940 H293984 H294027 H294069 H294112 H294157 H294199 H294241 H294286 H293897 H293941 H293985 H294028 H294070 H294113 H294158 H294200 H294242 H294287 H293898 H293942 H293986 H294029 H294071 H294114 H294159 H294201 H294243 H294288 H293899 H293943 H293987 H294030 H294072 H294116 H294160 H294202 H294244 H294289 H293900 H293944 H293988 H294031 H294073 H294117 H294161 H294203 H294245 H294290 H293901 H293946 H293989 H294032 H294074 H294118 H294162 H294204 H294246 H294291 H293902 H293947 H293990 H294033 H294075 H294119 H294163 H294205 H294247 H294292 H293903 H293948 H293991 H294034 H294076 H294120 H294164 H294206 H294248 H294293 H293904 H293949 H293992 H294035 H294077 H294121 H294165 H294207 H294250 H294294 H293905 H293950 H293993 H294036 H294078 H294122 H294166 H294208 H294252 H294295 H293906 H293951 H293994 H294037 H294079 H294123 H294167 H294209 H294253 H294296 H293907 H293952 H293995 H294038 H294080 H294124 H294168 H294210 H294254 H294297 H293908 H293953 H293996 H294039 H294081 H294125 H294169 H294211 H294255 H294298 H293909 H293954 H293997 H294040 H294082 H294126 H294170 H294212 H294256 H294299 H293910 H293955 H293998 H294041 H294083 H294127 H294171 H294213 H294257 H294300 H293911 H293956 H293999 H294042 H294084 H294128 H294172 H294214 H294258 H294301 H293912 H293957 H294000 H294043 H294085 H294129 H294173 H294215 H294260 H294302 H293913 H293958 H294001 H294044 H294086 H294130 H294174 H294216 H294261 H294303 H293914 H293959 H294002 H294045 H294087 H294131 H294175 H294217 H294262 H294304 H293915 H293960 H294003 H294046 H294088 H294132 H294176 H294218 H294263 H294305 H293916 H293961 H294004 H294047 H294089 H294133 H294177 H294219 H294264 H294306 H293917 H293962 H294005 H294048 H294090 H294134 H294178 H294220 H294265 H294307 H293918 H293963 H294006 H294049 H294091 H294135 H294179 H294221 H294266 H294308 H293919 H293964 H294007 H294050 H294092 H294136 H294180 H294222 H294267 H294309 H294310 H294352 H294395 H294438 H294489 H294533 H294586 H294636 H294690 H294761 H294311 H294353 H294396 H294439 H294490 H294534 H294587 H294637 H294693 H294763 H294312 H294354 H294397 H294440 H294491 H294535 H294588 H294639 H294694 H294766 H294313 H294355 H294398 H294441 H294492 H294536 H294589 H294640 H294695 H294771 H294314 H294356 H294399 H294442 H294493 H294537 H294590 H294641 H294696 H294773 H294315 H294357 H294400 H294443 H294494 H294538 H294591 H294642 H294698 H294779 H294316 H294358 H294401 H294444 H294495 H294539 H294592 H294643 H294699 H294782 H294317 H294359 H294402 H294445 H294496 H294540 H294593 H294644 H294700 H294783 H294318 H294360 H294403 H294446 H294497 H294541 H294594 H294645 H294701 H294794 H294319 H294361 H294404 H294447 H294498 H294542 H294595 H294646 H294705 HCX4019 H294320 H294362 H294406 H294448 H294499 H294543 H294597 H294647 H294706 HCX4138 H294321 H294363 H294407 H294449 H294500 H294544 H294598 H294649 H294711 HCX4344 H294322 H294364 H294408 H294450 H294501 H294545 H294599 H294650 H294712 HCX4400 H294323 H294365 H294409 H294451 H294502 H294546 H294600 H294652 H294713 H294324 H294366 H294410 H294458 H294503 H294547 H294601 H294653 H294714 H294325 H294367 H294411 H294460 H294504 H294548 H294602 H294654 H294715 H294326 H294368 H294412 H294461 H294505 H294549 H294603 H294656 H294716 H294327 H294369 H294413 H294462 H294506 H294550 H294604 H294657 H294719 H294328 H294370 H294414 H294463 H294507 H294551 H294605 H294658 H294720 H294329 H294371 H294415 H294465 H294508 H294552 H294606 H294659 H294723 H294330 H294372 H294416 H294467 H294509 H294553 H294608 H294660 H294724 H294331 H294373 H294417 H294468 H294510 H294554 H294610 H294663 H294726 H294332 H294374 H294418 H294469 H294511 H294555 H294611 H294664 H294727 H294333 H294376 H294419 H294470 H294513 H294556 H294612 H294665 H294728 H294334 H294377 H294420 H294471 H294514 H294557 H294613 H294666 H294729 H294335 H294378 H294421 H294472 H294515 H294565 H294615 H294667 H294730 H294336 H294379 H294422 H294473 H294516 H294567 H294616 H294668 H294731 H294337 H294380 H294423 H294474 H294517 H294568 H294617 H294671 H294732 H294338 H294381 H294424 H294475 H294518 H294569 H294618 H294674 H294735 H294339 H294382 H294425 H294476 H294519 H294571 H294619 H294675 H294736 H294340 H294383 H294426 H294477 H294520 H294572 H294620 H294676 H294737 H294341 H294384 H294427 H294478 H294521 H294573 H294621 H294677 H294738 H294342 H294385 H294428 H294479 H294523 H294574 H294623 H294678 H294742 H294343 H294386 H294429 H294480 H294524 H294575 H294624 H294679 H294743 H294344 H294387 H294430 H294481 H294525 H294576 H294625 H294680 H294745 H294345 H294388 H294431 H294482 H294526 H294577 H294626 H294681 H294746 H294346 H294389 H294432 H294483 H294527 H294580 H294627 H294682 H294747 H294347 H294390 H294433 H294484 H294528 H294581 H294629 H294683 H294750 H294348 H294391 H294434 H294485 H294529 H294582 H294630 H294684 H294751 H294349 H294392 H294435 H294486 H294530 H294583 H294632 H294685 H294752 H294350 H294393 H294436 H294487 H294531 H294584 H294634 H294686 H294753 H294351 H294394 H294437 H294488 H294532 H294585 H294635 H294689 H294758
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters on June 23, 2010. Firm initiated recall is ongoing.
REASON
Position errors may result in misdelivery of radiation.
VOLUME OF PRODUCT IN COMMERCE
5,741 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Recall # Z-1250-2011
CODE

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0000CZC7204X1H 0000FRB4330BBR 0000FRB43402W2 0000CZC720455C 0000FRB3270GWS 0000CZC5341NMT 0000CZC8261XGR 0000FRB44106C2 0000CZC822576X 0000FRB325099B 0000FRB3250C9Q 0000FRB31600Z3 0000CZC5230HJF 0000CZC5341NW3 0000CZC7111TNZ 0000CZC7111TNW 0000CZC7211D4G 0000CZC54812WR 0000CZC535013J 0000FRB316012V 0000CZC7110GQK 0000CZC724053C 00000020546D1C 0000FRB43402WN UNKH3800JA0000 000000208088-1 0000CZC8161XMH 0000CZC7105FJJ 0000FRB4330NQ6 0000CZC5300371 000000013MMMDW 0000FRB3250CB9 0000FRB4230Q3X 0000FRB43402XX 0000CZC724057G 0000CZC5341NV1 0000CZC6502HNB 0000CZC6502HNQ 0000CZC7110GR8 00000067354116 0000CZC5341NYK 0000CZC5361JV2 0000CZC5341NT2 0000FRB4330BB2 0000CZC912809D 0000CZC912756L 000000212502-2 0000000000B312 0000CZC7211D4V 0000CZC5341NMQ 0000CZC5341NMH 0000CZC6502HNC 0000CZC6501QYQ 0000CZC6501QYF 0000FRB43605GH 0000FRB43605H5 0000CZC5361J0H 0000FRB4360DVC 0000CZC7205DLJ 0000CZC5230HJT 0000CZC5341NBG 0000CZC5341NFW 0000FRB316013Y 00000000208542 0000CZC5361JTT 0000000L3N2113 00000000210138 0000FRB43705M9 0000FRB4330NPG 0000CZC7205DGW 000000212902-1 00000000212092 000000212502-2 000000212902-5 000000212902-3 000000017643-6 00000000209511 000000211982-2 00000000211982 0000CZC912758L 0000FRB4330B3N 0000CZC8283V00 00000000206030 00000000210858 0000001C11881A 00000026646D9E 00000000210860 000000210145-1 0000CZC7240544 0000CZC912807P 0000CZC9127SMW 0000FRB4370D9Y 0000FRB4370D9S 0000FRB4370D9Z 0000FRB4370B1N 0000FRB437092N 0000FRB43605J4 00000000210870 0000FRB41308VV 0000CZC90243D9 00000000211925 0000CZC8224ZM8 00000000208245 000000208245-1 0000CZC548134B 0000CZC7105FCV 0000CZC7105FCJ 00000000211721 0000007D853898 0000FRB42508S5 0000FRB42508QF 00000000209243 0000CZC7205DL8 0000CZC5300370 000000212184-2 0000CZC530036V 0000FRB4380P1V 00000000209622 0000CZC7110GP7 0000CZC7212DYX 0000CZC55207LR 0000CZC55207KH 00000000208265 0000CZC55207M0 0000CZC55207LM 0000CZC6505DRB 000000208713-2 0000CZC8283V5P 00000066D4878C 000000210680-1 0000CZC8273NPQ 0000004F79879B 0000CZC7212F4B 0000CZC7205DN7 0000007F7563BD 000000013N2191 0000FRB32808BF 0000FRB3280837 0000FRB325097Z 0000FRB3250969 0000FRB32808C3 0000FRB325088F 0000FRB31200VX 0000FRB40907KP 0000FRB40907L5 0000FRB4400JOB 000000205944-0 0000FRB43607GB 00000000209748 0000CZC5341P1J 0000CZC5341NPY 0000FRB4380P1H 0000CZC5361JTL 0000CZC65012YW 0000CZC7205DMP 0000000I3MN253 0000CZC6505DRL 0000CZC7205DK8 0000000L3NY687 0000CZC724052W 0000CZC7204X7K 0000CZC7211D48 0000CZC5230HDK 0000CZC6502HK4 0000CZC7204X6P 0000CZC7211D3G 0000CZC7211D3Z 0000CZC7211D3Q 0000CZC912755T 00000000212190 0000CZC7240584 0000000L3RX442 0000CZC8273Z9T 0000CZC7204X5Y 0000CZC724052R 0000000L3RY148 0000CZC8283V2Z 0000CZC8273NPG 0000CZC8225772 0000000L3RX421 0000000L3RX434 0000CZC8283V86 00000019FF6AF7 0000CZC83942HF 0000CZC83942LM 0000CZC8273ZD3 0000CZC83942L6 0000CZC83942KF 0000CZC7110GPM 0000CZC8224ZM7 0000CZC91280BS 00000002117164 0000CZC9127566 0000CZC9127S81 0000CZC9127569 0000CZC94158RC 0000CZC8273Z96 0000CZC8161XGW 0000CZC724056B 0000CZC724055F 0000CZC7205DGH 0000FRB325088H 0000FRB32509C1 0000FRB325088M 0000FRB3280C75 0000FRB3270C80 0000FRB3260GX3 0000FRB4330NPZ 0000CZC8161XLF 0000FRB4370DB2 0000FRB44103KT 0000FRB44103KG 000000099HXVYA 0000FRB44103L1 0000FRB43607G3 0000FRB44103L8 0000000L3MN264 00000000079342 0000FRB43607GP 0000CZC5230HCH 0000CZC8283TXT 0000MZC7211D5S 0000CZC5480KT2 0000CZC5341NPD 0000CZC5471PLS 0000CZC6501QVX 0000CZC6501QYN 0000CZC5471PM1 0000CZC7105FKL 0000CZC7105FPN 0000004143356C 0000CZC724055Y 00000000210279 000000562FFCBB 0000CZC8161XGM 00000008422553 000000212470-1 0000004A656453 0000FRB32507MK 0000FRB3260B74 0000FRB42508Q8 0000CZC5341NT5 546045-7CB44D2 0000CZC5341NML 0000CZC5230HCR 0000CZC5341N9L 0000CZC6801QXZ 000000110BBEB0 00000000207935 00000000207934 0000CZC6502HLW 0000CZC7205DN5 0000CZC724054D 0000CZC6501QWP 0000CZC7212DW6 0000CZC724057Y 0000CZC7110GNP 0000CZC7205DGL 0000CZC7240538 0000CZC7240556 0000CZC7212DZW 000000665ED336 0000CZC9127527 0000CZC94158ZJ 0000CZC9127SCG 0000CZC94158YK 0000CZC9127SGB 0000CZC9127571 0000FRB325098R 0000FR30310039 0000CZC912752H 0000FRB43708SZ 0000FRB43607GX 0000CZC5230HH0 0000CZC9127SK0 0000CZC5341P3K 0000CZC6502HJL 0000CZC6502HLW 0000CZC6502HGQ 0000CZC724055R 0000CZC724054Z 0000CZC8161XLD 0000CZC912752K 0000CZC912752M 0000CZC9127540 0000CZC7240572 0000FRB42508W5 0000CZC7204X5F 000000206344-2 0000CZC8283TYC 0000FRB31600YJ 0000CZC7204X7V 0000FRB3250961 0000FRB42508WO 0000FRB42508VF 0000FRB4330BBJ 0000CZC7105FF0 0000CZC7204X57 000000210226-4 0000CZC7212DZD 0000CZC7212DZC 00000000211690 0000FRB3260BBT 0000000L3MN248 0000000I3MN248 0000CZC7110GNY 0000CZC7204X19 0000CZC7105FJG 0000CZC6505DP6 0000CZC7212DWM 000000207312-0 0000CZC5471PM4 0000CZC7240529 0000CZC9127SJH 000000110229-2 00000045EAFF1F 000000109885-4 00000006FF2DDE 0000CZC8161XNQ 00000109541-25 0000CZC5300366 0000CZC5361J11 0000CZC7212DY6
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated January 12, 2011.
Manufacturer: GE Medical System Israel LTD, Tirat Hacarmel, Israel. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Brain SPECT when 2 result series are opened in compare mode. These issues may impact patient safety
VOLUME OF PRODUCT IN COMMERCE
6,046 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data. Recall # Z-1251-2011
CODE
Units: GFD259, GFD129, GFD729, GFD708, GND229, GND116, GFD296, GFD201, GND83, GFD815, GFD2127, GFD2128, GFD2130, GFD2131, GND148, GFD06, GND44, GFD621, GFD352, GND157, GND181, GFD312, GFD106, GFD351, GND79, GFD1000, GFD1001, GFD249, GFD2247, GFD2265, GFD874, GND227, GND55, GFD529, GFD770, 9903005129, GND223, GFD216, GFD416, GFD915, GFD908, SH00208, SH00226, GFD688,M GFD746, GND246, GFD526, GFD571, GFD976, GFD633, GFD879, GFD919, GFD1013, GFD841, GFD869, GFD979, GFD12, GFD808, GFD524, GFD940, GFD271, GFD517, GFD760, GFD327, GND176, GFD780, GFD779, GFD412, GFD634, GFD42, GFD700, GND184, GFD538, GND76, GFD280, GND39, GFD109, GFD337, GND208, GFD65, GFD481, GFD212, GFD870, GFD792, GND24, GFD817, GFD776, GFD81, GND30, GFD163, GFD21, GND45, GND62, GFD1164, GFD861, GFD862, GFD1053, GFD1057, SH00008, SH0013, SH0033, GFD2316, GFD2318, GND147, GFD938, GFD657, GFD920, GFD924, GND109, GFD18, GFD494, GFD495, GND230, GFD559, GFD707, GFD692, GFD966, GFD968, GFD165, GFD133, GFD522, GFD520, GFD523, GFD762, GFD821, GND258, GFD43, GFD0054, GFD0055, GND178, GND36, GFD358, GFD256, GND80, GFD1076, GFD138, GFD617, GFD184, GFD194, GFD130, GFD96, GFD2174, GFD2272, GFD1062, GFD140, GFD117, GFD264, GND65, 9906005540, GFD804, GND165, GFD823, GFD1060, GFD101, GFD189, GND60, GFD137, GND94, GFD1066, GND216, GFD689, GFD223, GFD83, GFD99, GFD381, GFD706, FD662, GFD664, GFD237, GND185, GFD845, GFD26, GND126, GFD277, GFD284, GFD2245, GFD2246, GND135, GFD50, GFD200, GFD228, GFD2270, GFD2221, GND233, GND264, GFD671, GFD343, GFD91, GFD652, GFD281, GFD414, GND231, GND71, GFD120, GFD582, GFD690, GFD696, GFD697, GFD878, GFD71, GFD360, GFD368, GND40, GFD17, GFD658, GFD152, GFD660, GFD893, GND200, GFD831, GFD850, GFD69, GND122, GFD840, GFD698, GFD709, GND48, GND152, GND52, GFD1080, GFD809, GFD1059, GFD2264, GFD2229, GND192, GFD145, GFD820, GFD198, GFD188, GND172, GFD822, GND16, GND57, GFD41, GFD912, GFD917, GFD267, GFD998, GFD247, GFD255, GND10, GND123, GND31, GFD68, GFD632, GFD74, GFD934, GND159, GFD239, GFD261, GFD235, GFD521, GFD613, GFD399, GFD161, GND47, GFD843, GFD863, GFD865, SHO0165, GFD190, GFD816, GFD328, GFD557, GFD558, GND190, GFD19, 000000000000002, GFD824, GND27, GFD618, GND226, GND35, GND134, GND41, GND238, GFD257, GFD132, GFD543, 9904005345, GFD555, GFD143, GFD1000, GFD300, GND215, GND108, GFD586, GFD288, GND250, GFD033, GFD218, GND221, GND224, GFD107, GFD832, GFD278, GFD295, GFD1005, GFD725, GFD573, GFD667, GFD680, GFD956, GND194, GFD1971, GFD630, GFD587, GND28, SH00159, SH00160, GFD361, GFD370, GFD619, GFD620, GFD384, GFD156, GFD362, GFD914, GFD301, GFD1054, GND263, GFD733, GFD735, GFD913, GND189, GND167, GFD909, GFD376, GFD116, GFD903, GFD699, GFD317, GND161, GFD906, GFD186, GND193, GFD58, GFD234, GFD519, GND89, GFD730, GND261, GFD527, GFD391, GFD250, GFD763, GFD103, GFD483, GFD51, GND63, GND86, GFD778, GFD82, GFD948, GFD382, GFD747, GFD825, GFD556, GND75, GFD480, 9902005057, GND245, GND191, GND269, GND111, GFD205, GND84, GND170, GFD67, GFD232, GND96, GND100, GND22, GFD554, GND49, GND17, GFD2249, GFD2260, GFD1946
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated June 22, 2009.   
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. FDA initiated recall is complete.
REASON
New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.
VOLUME OF PRODUCT IN COMMERCE
379 units                                                                         
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall # Z-1252-2011
CODE
Units: 105257, 105803, 105941, 105982, 105984, 151024, 151038, 151051, 151053, 151055, 151073, 151074, 151084, 151110, 151130, 151141, 151151, 151156, 151157, 151160, 151168, 151173, 151178, 151216, 151245, 151250, 151256, 151258, 151259, 151260, 151298, 151301, 151309, 151317, 151319, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151371, 151387, 151391, 151394, 151396, 151398, 151410, 151411, 151412, 151416, 151418, 151423, 151432, 151433, 151435, 151441, 151443, 151446, 151467, 151479, 151504, 151507, 151514, 151515, 151517, 151519, 151521, 151522, 151523, 151530, 151538, 151540, 151545, 151557, 151558, 151566, 151567, 151568, 151574, 151584, 151585, 151587, 151595, 151598, 151601, 151611, 151616, 151623, 151626, 151627, 151628, 151632, 151634, 151636, 151640, 151653, 151664, 151672, 151674, 151675, 151678, 151683, 151684, 151689, 151694, 151695, 151696, 151698, 151699, 151700, 151704, 151705, 151708, 151710, 151714, 151722, 151724, 151728, 151729, 151734, 151736, 151751, 151759, 151760, 151763, 151764, 151765, 151770, 151774, 151779, 151782, 151783, 151785, 151789, 151791, 151793, 151801, 151802, 151803, 151805, 151808, 151809, 151810, 151811, 151812, 151820, 151828, 151839, 151842, 151847, 151848, 151855, 151860, 151864, 151866, 151867, 151875, 151881, 151882, 151885, 151886, 151892, 151931, 151933, 151942, 151952, 151953, 151955, 151956, 151958, 151959, 151960, 151961, 151965, 151969, 151977, 151978, 151981, 151989, 152008, 152019, 152023, 152031, 152043, 152051, 152064, 152079, 152080, 152091, 152098, 152103, 152115, 152116, 152117, 152123, 152126, 152154, 152158, 152163, 152174, 152175, 152176, 152177, 152192, 152200, 152210, 152211, 152214, 152217, 152220, 152222, 152223, 152232, 152246, 152257, 152271, 152301, 152307, 152308
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letters dated January 5, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON
Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.
VOLUME OF PRODUCT IN COMMERCE
224 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) 1) Flexicair� II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3. Z-1253-2011;

2) Flexicair� MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3. Recall # Z-1254-2011
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by letter dated December 15, 2010. Firm initiated recall is ongoing.
REASON
Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060. Recall # Z-1255-2011;

2) Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing, Hospilak REF 100-E Aerosol Mask Adult Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, Adult with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eValueMed Tri-anim Adult Oxygen Mask Elongated adult non-rebreathing oxygen mask with check valve, two side valves, 7 smooth bare tubing Part Number 301-182 eValueMed Unomedical, Inc., Hospilak REF No. 3102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak REF No. 3106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3120-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3182-E 3-in-1 Emergency Mask Elongated Adult, 7 (2.1m) Oxygen Tubing with Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3222-E Medium Concentration Oxygen Mask Pediatrict with 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3224-High Concentration Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3224-High Concentration Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3225-E High Concentration Non-Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3227-E Venturi Mask Kit, Pediatric, All Diluters, Oxygen Tubing with FitsAll Oxygen Connector Unomedical, Inc., Hospilak REF No. 3230-E High Concentration, Non-Rebreather Oxygen Mask, Pediatric with 7 (2.1m) Oxygen tubing Fits-all Oxygen Connector Unomedical, Inc., Hospilak REF No. 3247-E Venturi Trach Mask Kit, Adult All Diluters Unomedical, Inc., Hospilak REF No. 3262-E Oxygen Mask Infant, Medium Concentration w/ 7 (2.1m) Oxygen Tubing, Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3264-E High Concentration Rebreather Oxygen Mask, Infant w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3266-E High Concentration Non- Rebreather Oxygen Mask, Infant w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3776-E OPTI-MIST CLEAR Nebulizer w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 3777-E OPTI-MIST CLEAR Nebulizer w/7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 753-E OPTI-MIST Nebulizer kit, w/7 (2.1m) Oxygen Tubing, and Adult Mask Unomedical, Inc., Hospilak REF No. 776-E OPTI-MIST Clear Nebulizer kit, w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 777-E OPTI-MIST Clear Nebulizer kit, w/7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Unomedical, Inc., Ref. No. 953-E UP-MIST Nebulizer Kit, with 7 (2.1m) Oxygen Tubing, Aerosol Mask, Adult The following are under McKesson brand: McKesson Aerosol Mask, Elongated Adult No Tubing, Reorder No. 86-100E. Oxygen Mask, Elongated Adult Medium Concentration, 7 (2.1m) Oxygen Tubing Reorder No. 86-102E Oxygen Mask, Elongated Adult High Conc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, Check Valve, One Side Valve Reorder no. 86-106 E. Oxygen Mask, Elongated Adult High COnc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, Check Valve, Two Side Valves Re-order No. 86-108E 3-1 Emergency Masks, Elongated Adult, 7 (2.1m) Oxygen Tubing Reorder no. 86-182 E Oxygen Mask, Adult Medium Concentration, 7 (2.1m) Oxygen Tubing Reorder no. 86-202E Aerosol Mask, Elongated Pediatric No Tubing Reorder No. 86-220E Oxygen Mask, Elongated Pediatric Medium Concentration, No Tubing Reorder No. 86-223E Up-mist Nebulizer Kit, with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Reprder No. 86-228E Trach Mask Adult, No Tubing Reorder No. 86-245E Oxygen Mask, Elongated Pediatric, High Conc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, w/FITS-ALL Oxygen Connector Reorder no. 86-3226E OPTI-MIST Clear Nebulizer Kit w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Reorder No. 86-776E OPTI-MIST CLEAR Nebulizer, Kit w/ 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Reorder No. 86-777E ******** Smiths Medical Portex First Breath Adult Oxygen Mask with Tubing, 213 cm (7 ft) Ref 001421 Smiths Medical Portex First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213 cm (7 ft) (Non-latex) Ref 001423 Smiths Medical Portex First Breath Adult Aerosol Mask (Non-Latex) Ref 001426 Smiths Medical Portex First Breath Adult Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag and Tubing, 213 cm (7 ft.) Ref 001431 Smiths Medical Portex First Breath Pediatric Medium Concentration Oxygen Mask with Tubing , 213 cm (7ft) (Non-Latex) Ref 001431 Smiths Medical Portex First Breath Pediatric Aerosol Mask (Non-latex) Ref 001476 Smiths Medical Portex First Breath Adult Venturi Oxygen Mask with corrugated tubing, 02 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-Latex) Ref 002610 Smiths Medical Portex First Breath Adult Venturi Oxygen Mask with corrugated tubing, 02 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-Latex) Ref 002620 The following are under Metro brand: Metropolitan Medical, Inc Metro Disposable Latex Free Medium Concentration Oxygen Mask 7 ft. Universal Oxygen Tubing Reorder number 7102 360-4. Pediatric Medium Concentration Oxygen Mask & 7 ft. Universal Oxygen Tubing Reorder Number 7222 Pediatric Non-Rebreather Oxygen Mask & 7 ft. Universal Oxygen Tubing Reorder number 7226 ******* Owens & Minor MediChoice Opti-mist Clear Nebulizer w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Re-Order #RSP0470 The following are under MediChoice Brand MediChoice Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing RE-Order #RSP111 , #RSP1112, MediChoice High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1m) Oxygen Tubing Re-order #RSP1120 MediChoice Medium Concentration Mask, Adult 7 (2.1m) tubing Re-order #RSP1200, RSP 1200A MediChoice Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing Re-order #RSP1200P MediChoice Adult Trach Mask Re-Order #RSP2000 MediChoice Venturi Mask Kit, Adult All Diluters No-Crush Lumen Oxygen Tubing Re-Order # RSP4005 MediChoice Adult Aerosol Mask Re-Order #RSP5000 MediChoice Aerosol Mask, Pediatric Re-Order #RSP5000P. Recall # Z-1256-2011
CODE
Numerous lots produced between June 2009 and September 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Convatec Inc., Skillman, NJ, by letters dated January 7, 2011. 
Manufacturer: Unomedical S.A. de C.V. Reynosa, Tam, Mexico. Firm initiated recall is ongoing.
REASON
Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.
VOLUME OF PRODUCT IN COMMERCE
2,692,300 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner. Recall # Z-1257-2011
CODE
Serial No.: 2DA0872038, 2DA0962116, 2DA0862034, 2DA09Z2161, 2DA07X2008, 2DA1012165, 2DA08X2072, 2DA09Y2151, 2DA0842023, 2DA07X2005, 2DA1012168, 2DA08X2067, 2DA0882053, 2DA0862036, 2DA08Z2092, 2DA0882051, 2DA09Z2162, 2DA1072211, 2DA09X2143, 2DA08Y2077,2DA09X2139, 2DA08X2070, 2DA0982133 2133, 2DA0842026, 2DA0882052, 2DA0972123, 2DA08Y2080, 2DA0882048, 2DA08X2063, 2DA09Y2148, 2DA1012170, 2DA08X2071, 2DA1012169, 2DA0952115, 2DA0982131, 2DA07Y2010, 2DA08X2061, 2DA1012167, 2DA0882049, 1DA0962006, 1DA09Y2014, 1DA0992011, 1DA0972007, 1DA0972008, 2DA1012166, 2DA09Z2158, 2DA1072212, 2DA1012174, 2DA0792004, 2DA1062208, 2DA0792002, 1DA1062015, 1DB1072012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, by letter on September 7, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  
REASON
Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.
VOLUME OF PRODUCT IN COMMERCE
44 unit
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide Intended use: Measurement of Hemoglobin A1c in human whole blood. Catalog No. 270-2716. Recall # Z-1259-2011
CODE
Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letters dated February 5, 2010, and February 16, 2010. Firm initiated recall is ongoing.
REASON
The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantization of the blood results.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
1) Product Number: 02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1261-2011;

2) Product Number: 02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1262-2011;

3) Part Number: 02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1263-2011;

4) Part Number: 02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1264-2011;

5) Part Number: 02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1265-2011;

6) Part Number: 02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1266-2011;

7) Part Number: 02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1267-2011;

8) Part Number: 02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1268-2011;

9) Part Number: 02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1269-2011;

10) Part Number: 02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1270-2011;

11) Part Number: 02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1271-2011;

12) Part Number: 02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1272-2011;

13) Part Number: 02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1273-2011;

14) Part Number: 02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SysteFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1274-2011;

15) Part Number: 02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1275-2011;

16) Part Number: 02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1276-2011;

17) Part Number: 02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1277-2011;

18) Part Number: 02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1278-2011;

19) Part Number: 02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall  # Z-1279-2011;

20) Part Number: 02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1280-2011;

21) Part Number: 02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1281-2011;

22) Part Number: 02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade PlatFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.e System. Recall # Z-1282-2011;

23) Part Number: 02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1283-2011;

24) Part Number: 02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1284-2011;

25) Part Number: 02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1285-2011;

26) Part Number: 02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1286-2011;

27) Part Number: 02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1287-2011;

28) Part Number: 02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1288-2011;

29) Part Number: 02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1289-2011;

30) Part Number: 02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1290-2011;

31) Part Number: 02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1291-2011;

32) Part Number: 02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1292-2011;

33) Part Number: 02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1293-2011;

34) Part Number: 02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1294-2011;

35) Part Number: 02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1295-2011;

36) Part Number: 02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1296-2011;

37) Part Number: 02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1297-2011;

38) Part Number: 02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1298-2011;

39) Part Number: 02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1299-2011;

40) Part Number: 02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-300-2011;

41) Part Number: 02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1301-2011;

42) Part Number: 02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1302-2011;

43) Part Number: 02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1303-2011;

44) Part Number: 02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1304-2011;

45) Part Number: 02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1305-2011;

46) Part Number: 02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1306-2011;

47) Part Number: 02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1307-2011;

48) Part Number: 02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1308-2011;

49) Part Number: 02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1309-2011;

50) Part Number: 02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1310-2011;

51) Part Number: 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1311-2011;

52) Part Number: 02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1312-2011;

53) Part Number: 02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1313-2011;

54) Part Number: 02.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1314-2011;

55) Part Number: 02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1315-2011;

56) Part Number: 02.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1316-2011;

57) Part Number: 02.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1317-2011;

58) 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade, Part Number: 02.122.621S, Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1318-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 20, 2010.
Manufacturer: Synthes (USA), Horseheads, NY. Firm initiated recall is ongoing.
REASON
Potential for out of specification star grind teeth.
VOLUME OF PRODUCT IN COMMERCE
593 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W; Intended use: Intravascular Administration Set. Recall # Z-1319-2011;

2) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-site; Item # T090-000V, Intended use: Intravascular Administration Set. Recall # Z-1320-2011;

3) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-site and 0.22, Intended use: Intravascular Administration Set. Recall # Z-1321-2011;

4) “20 drop IV Administration Set; Item # T090-000, Intended use: Intravascular Administration Set. Recall # Z-1322-2011;

5) Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1, Intended use: Intravascular Administration Set. Recall # Z-1323-2011;

6) WalkMed Infusion 100” 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip, Item # T100-000F, Intended use: Intravascular Administration Set. Recall # Z-1324-2011;

7) Churchill Medical 78” Stopcock Extension Set with male/female red cap; item # AMS-464-1 Intended use: Intravascular Administration Set. Recall # Z-1325-2011;

8) Churchill Medical Systems 6” Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter Item Number: AMS-944, Intended use: Intravascular Administration Set. Recall # Z-1326-2011;

9) Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 The Lifeguard. Recall # Z-1327-2011;

10) WalkMed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Item # T100-000F Intended use: Intravascular Administration Set. Recall # Z-1328-2011;

11) Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451; Intended use: Intravascular Administration Set. Recall # Z-1329-2011;

12) Churchill Medical Systems 14"Extension Set with SmartSite Injection, Item # 43000E; Intended use: Intravascular Administration Set. Recall # Z-1330-2011;

13) Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1; Intended use: Intravascular Administration Set. Recall # Z-1331-2011;

14) FMI 105"Oral Surgery Administration Set; Item AMS-468-1; Intended use: Intravascular Administration Set. Recall # Z-1332-2011;

15) Winged Infusion Set with 90 degree Huber Needle and Y Injection Site, Item # FIY-2210; Intended use: Intravascular Administration Set. Recall # Z-1333-2011
CODE
1) Lot Number: 1010030;
2) Lot Number: 1010025, 1010067;
3) Lot Number: 1010009;   
4) Lot Numbers: 1010038, 1010070;
5) Lot Number: 10J34;
6) Lot Number: 1010111;
7) Lot Number: 1009166;
8) Lot Number: 1009163;
9) Lot Number: 1010004;
10) Lot Number: 1010111;
11) Lot Number: 1010018;
12) Lot Number: 1010011;
13) Lot Number: 10J47;
14) Lot Number: 1010066;
15) Lot Number: 1010034
RECALLING FIRM/MANUFACTURER
Churchill Medical Systems, Inc., Dover, NH, by letter dated November 16, 2010. Firm initiated recall is ongoing.
REASON
Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
VOLUME OF PRODUCT IN COMMERCE
79,782 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery. Recall # Z-1335-2011;

2) Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery. Recall # Z-1336-2011;

3) Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery. Recall # Z-1337-2011;

4) CYNACON OCuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery. Recall # Z-1338-2011;

5) Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery. Recall # Z-1339-2011;

6) Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery. Recall # Z-1340-2011
CODE
1) Units: 163346, 163381, 1663384;

2) 2010-10-07, 2012-10-12, 2012-11-30, 2012-12-15, 2013-04-09, 2013-04-23, 2013-05-21, 2013-09-01, 2013-10-01;

3) Units: 2010-12-09, 2013-02-23, 2013-08-12, 2013-09-24;

4) Units: 2012-08-24, 2012-10-12, 2012-11-17, 2012-12-15;

5) Units: 2010-10-14, 2010-12-02, 2012-02-03, 2012-03-17, 2012-04-14, 2012-06-23, 2012-07-20, 2012-10-12, 2012-11-30, 2013-03-12, 2013-04-08, 2013-04-22, 2013-07-28, 2013-09-01;

6) Units: 2013-01-12, 2013-09-13
RECALLING FIRM/MANUFACTURER
Aspen Surgical Products, Inc., Caledonia, MI, by letters dated December 23, 2010. Firm initiated recall is ongoing.
REASON
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
VOLUME OF PRODUCT IN COMMERCE
77,850 units
DISTRIBUTION
Nationwide, Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel
___________________________________
PRODUCT
Celite ACT Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis. 510 K number K992571. Recall # Z-1341-2011
CODE
Serial Lot Expire Date Total R09241A 2/14/2010 6300 R09257 2/28/2010 11150 R09265 3/14/2010 1775 R09268B 3/14/2010 12475 R09274B 3/28/2010 10150 R09277 3/28/2010 13750 R09278B 3/28/2010 16975 R09284 3/28/2010 14375 R09285 3/28/2010 16725 R09291 4/14/2010 21825 R09292 4/14/2010 9600 R09297 4/14/2010 16800 R09298 4/14/2010 15100 R09298A 4/14/2010 12700 R09303C 4/28/2010 13925 R09304 4/28/2010 22400 R09306 4/28/2010 16825 R09307 4/28/2010 14025 R09317B 4/28/2010 10550 R09329C 5/14/2010 13225 R09330A 5/14/2010 16700 R09330B 5/14/2010 12675 R09340 5/28/2010 21750 S09344 5/28/2010 16325 S09353 6/14/2010 13925 S10015A 7/14/2010 7000 S10017 7/14/2010 8650 S10026A 7/14/2010 18900 S10027A 7/14/2010 16375 S10032A 7/28/2010 11925 S10041 7/28/2010 15725 S10042 7/28/2010 12850 S10047A 8/14/2010 11525 S10056D 8/14/2010 14175 S10061C 8/28/2010 18225 S10062 8/28/2010 5850 S10070 8/28/2010 11200 S10071 8/28/2010 12150 S10073 8/28/2010 13700 S10097 9/28/2010 22775 S10098 9/28/2010 12400 S10099 9/28/2010 16450 S10107B 10/14/2010 11950 S10113 10/14/2010 18575 S10114A 10/14/2010 10725 S10117A 10/14/2010 19400 S10118A 10/14/2010 16200 S10127A 10/28/2010 17050 S10127B 10/28/2010 18900 S10136A 10/28/2010 18250 S10150A 11/14/2010 18950 S10151 11/14/2010 20475 S10155 11/28/2010 6075 S10167B 11/28/2010 15150 S10171 12/14/2010 21650 S10171A 12/14/2010 18050 S10173C 12/14/2010 17200 S10186A 12/28/2010 5800 S10188 12/28/2010 17475 S10188A 12/28/2010 17450 S10192 12/28/2010 16850 S10193 12/28/2010 18625 S10193A 12/28/2010 17300 S10195 12/28/2010 1650 S10220C 1/28/2011 3450 S10241 2/14/2011 3050 S10247A 2/28/2011 6825 S10254C 2/28/2011 13475 S10258C 3/14/2011 2425 S10263B 3/14/2011 9250 S10263D 3/14/2011 2450 S10263E 3/14/2011 7450 S10264A 3/14/2011 7300 S10264C 3/14/2011 5625 S10278 3/28/2011 8025 S10278C 3/28/2011 6000 S10280B 3/28/2011 4975 S10288 3/28/2011 7325 S10288A 3/28/2011 7325 S10295 4/14/2011 7000 S10295A 4/14/2011 2800 S10299B 4/14/2011 8850 S10303C 4/28/2011 8425 S10308 4/28/2011 8975 S10308B 4/28/2011 9550 S10309 4/28/2011 10075 S10309C 4/28/2011 6425 S10309E 4/28/2011 12975 S10310A 4/28/2011 5200 S10310C 4/28/2011 275 T10224D 1/28/2011 21100 T10232A 2/14/2011 9200 T10259A 3/14/2011 13075 T10293A 4/14/2011 6625 T10294 4/14/2011 5825 T10294A 4/14/2011 7300
RECALLING FIRM/MANUFACTURER
Abbott Point Of Care Inc., Princeton, NJ, by letter dated November 2010, and December 3, 2010. Firm initiated recall is ongoing
REASON
Celite ACT cartridges have increased numbers of values outside the accepted allowable.
VOLUME OF PRODUCT IN COMMERCE
1,164,275 cartridges
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes): a) AK-03000, b) AM-03000, c) BH-03000, d) DH-03000, e) KC-03000, f) SA-03001 and g) SH-03001. Epidural Anesthesia Kit. Recall # Z-1343-2011;

2) INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 Internal jugular puncture kit. Recall # Z-1344-2011;

3) PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit. Recall # Z-1345-2011;

4) ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kit. Recall # Z-1346-2011;

5) VESSEL CATHETERIZATION KIT/Product SKU's (Codes): a) AK-04550, b) AK-4550-A and c) ASK-04550-TG. Vessel catheterization kit. Recall # Z-1347-2011;

6) CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes): a) AK-04650-E and b) AK-04660. Central venous catheterization kit. Recall # Z-1348-2011;

7) JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit. Recall # Z-1349-2011;

8) EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) EPIDURAL CATHETER -- Product SKU (Code) AP-08100. Epidural catheterization kit. Recall # Z-1350-2011;

9) ACCESS TRAY/Product SKU's (Codes): a) ASK-03000-CHUQ, b) ASK-03000-CHUQ1, c) ASK-04001-GFH, d) ASK-04001-SUH and e) ASK-04001-UHC. Access tray for epidural anesthesia kit. Recall # Z-1351-2011;

10) EPIDURAL ANESTHESIA KIT/Product SKU's (Codes): a) ASK-03001-KC, b) ASK-03001-KC1 and c) HH-03000. Epidural anesthesia kit. Recall # Z-1352-2011;

11) PREP TRAY/Product SKU (Code) ASK-04001-SLE. Prep tray for epidural anesthesia kit. Recall # Z-1353-2011;

12) NERVE BLOCK PREP TRAY/Product SKU (Code) ASK-04001-VCU. Nerve block prep tray for epidural anesthesia kit. Recall # Z-1354-2011;

13) ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit. Recall # Z-1355-2011;

14) RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery catheterization kit. Recall # Z-1356-2011;

15) QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit. Recall # Z-1357-2011;

16) ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes): a) CC-04100, b) FS-04510, c) NS-04100 and d) PW-04100. Cardiovascular catheterization kit. Recall # Z-1358-2011;  

17) RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1. Cardiovascular catheter wire guide. Recall # Z-1359-2011;

18) ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial artery catheterization set. Recall # Z-1360-2011;

19) EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code) NH-05501. Anesthesia conduction kit. Recall # Z-1361-2011
CODE
1) a) Lot Numbers: RF0020735, RF0035260, RF0048279, RF0074386, RF5033131, RF5043814, RF5054886, RF5072941, RF5107406, RF5118270, RF6011018, RF6045801, RF6079491, RF6081233, RF6103625, RF7018712, RF7020460, RF7054076, RF7089370, RF7091000, RF7124568, RF8020964, RF8045881, RF8072854, RF8083651, RF8097339, RF8123912, RF9042571, RF9086457, and RF9125787; b) Lot Numbers: RF0021939, RF0059446, RF0088369, RF5129734, RF6057409, RF6116605, RF7088733, RF8071779, RF8123969, RF9070874, RF9100154 and RF9114379; c) Lot Numbers: RF0019618, RF0047612, RF0060793, RF0087742, RF8031875, RF8057376, RF8084126, RF8110915, RF8123973, RF9043981, RF9044684, RF9068606, RF9085979 and RF9100926; d) Lot Numbers: RF0019622, RF0020877, RF0075585, RF8032658, RF8056830, RF8072009, RF8119791, RF9027240, RF9043983, RF9068609, RF9071992, RF9100168 and RF9112897; e) Lot Numbers: RF0019721, RF0019727, RF0062036, RF0076951, RF7032320, RF7055209, RF7088801, RF7101703, RF7102262, RF8017549, RF8056557, RF8084129, RF8119798, RF9015804, RF9057951, RF9099001 and RF9126884; f) Lot Numbers: RF8021034, RF8069022, RF8108468, RF8123597, RF9028904, RF9056328, RF9097652 and RF9101076;  g) Lot Numbers: RF0017728, RF0022606, RF0059476, RF0075693, RF8057235, RF8071390, RF8083724, RF8096352, RF8109029, RF8122700, RF9027311, RF9032220, RF9056916, RF9060668, RF9084115, RF9097727, RF9100901 and RF9114878;

2) Lot Numbers: RF0018975, RF0022666, RF0063422, RF0087612, RF5107030, RF5119129, RF5129996, RF6012024, RF6034966, RF6046200, RF6068548, RF6079525, RF6081311, RF6103626, RF6127038, RF7019125, RF7032328, RF7065841, RF7090233, RF7102114, RF7124570, RF8020116, RF8020746, RF8033340, RF8057411, RF8072077, RF8084420, RF8108025, RF8122236, RF8123291, RF9014648, RF9039391, RF9042572, RF9070841, RF9097328 and RF9114810;

3) Lot Numbers: RF0022667, RF0033740, RF0046478, RF0060733, RF0077188, RF0088407, RF5096037, RF5106234, RF5107292, RF5118200, RF5118780, RF5120565, RF6011373, RF6022682, RF6034425, RF6045659, RF6046109, RF6056924, RF6068239, RF6070321, RF6080609, RF6080850, RF6081520, RF6081708, RF6104136, RF6104601, RF6115551, RF6116665, RF6126992, RF6127587, RF7018408, RF7019248, RF7019349, RF7020641, RF7029585, RF7031002, RF7032409, RF7054068, RF7054442, RF7066512, RF7077049, RF7077980, RF7088148, RF7089033, RF7090321, RF7101971, RF7102066, RF7102169, RF8016471, RF8016662, RF8017377, RF8020057, RF8020145, RF8032058, RF8043583, RF8044115, RF8057399, RF8060575, RF8069060, RF8071107, RF8084932, RF8107598, RF8108167, RF8122713, RF9016397, RF9028165, RF9030309, RF9031619, RF9042926, RF9043901, RF9056771, RF9069749, RF9073047, RF9084363, RF9086547, RF9100268, RF9109832, RF9114301 and RF9126957;

4) Lot Numbers: RF0010114, RF0018132, RF0018136, RF0019643, RF0021353, RF0033300, RF0034146, RF0046480, RF0046481, RF0048286, RF0050653, RF0074357, RF0075298, RF0075818, RF0087266, RF0088221, RF0088410, RF8020974, RF8031688, RF8032978, RF8043751, RF8045887, RF8056218, RF8057412, RF8058042, RF8060183, RF8068874, RF8071805, RF8083442, RF8085102, RF8095660, RF8096096, RF8097344, RF8109477, RF8110962, RF8111746, RF8122816, RF9014694, RF9016821, RF9028787, RF9030080, RF9030930, RF9030931, RF9031616, RF9043905, RF9043906, RF9056711, RF9057855, RF9069064, RF9073049, RF9073283, RF9084368, RF9100470, RF9101082, RF9101137, RF9101623, RF9112089, RF9112769, RF9112997, RF9114268, RF9125843, and RF9127306;

5) a) Lot Numbers: RF0010265, RF0018842, RF0022005, RF0022669, RF0034147, RF0035268, RF0048287, RF0059345, RF0062443, RF0087619, RF8028881, RF8031667, RF8045033, RF8045886, RF8057927, RF8069061, RF8070645, RF8071944, RF8083671, RF8095448, RF8095827, RF8108233, RF8110473, RF8112162, RF8119849, RF9016806, RF9028387, RF9030312, RF9043419, RF9043907, RF9055441, RF9068560, RF9071697, RF9071851, RF9084369, RF9100405, RF9112397 and RF9126906; b) Lot Numbers: RF0019447, RF8043582 and RF9072630;  c) Lot Numbers: RF0021830, RF0047072, RF0061718, RF0075460, RF8107597, RF9016396, RF9030308, RF9042394, RF9068856, RF9069987, RF9085877, RF9100222 and RF9126420;

6) a) Lot Numbers: RF0019520, RF0021354, RF0046482, RF0046961, RF0063424, RF5117904, RF6022525, RF6023560, RF6023566, RF6045757, RF6057357, RF6079772, RF6092792, RF6104795, RF6105161, RF6127332, RF6127674, RF7018942, RF7031005, RF7031998, RF7054159, RF7077028, RF7090472, RF7091001, RF7112897, RF7124307, RF8016370, RF8020798, RF8029139, RF8045217, RF8056796, RF8058001, RF8071697, RF8072284, RF8083910, RF8095863, RF8108791, RF8110833, RF9016136, RF9044809, RF9072425, RF9083735, RF9085743 and RF9113835; b) Lot Numbers: RF0034148, RF0046483, RF0061650, RF0063020, RF0075819, RF0087771, RF5117911, RF5129632, RF6023024, RF6057559, RF6092439, RF6104845, RF7018862, RF7032229, RF7054430, RF7077080, RF7089171, RF7102397, RF8016283, RF8029410, RF8033120, RF8045315, RF8057243, RF8058270, RF8083403, RF8097345, RF8122721, RF9044663, RF9055442, RF9084406, RF9097333 and RF9114824;

7) Lot Numbers: RF0019521, RF0021355, RF0035270, RF0048289, RF0075820, RF0087622, RF8020975, RF8045579, RF8072078, RF8072511, RF8084428, RF8096134, RF8108839, RF8111695, RF8123388, RF9016822, RF9030939, RF9039585, RF9055444, RF9073109, RF9083736, RF9097334, RF9101715 and RF9126227;

8) Lot Numbers: RF0058668, RF0059099, RF8095615, RF9055826 and RF9085255;

9) a) Lot Numbers: RF7125131, RF8044816, RF9056379, RL8088126 and RL8118762; b) Lot Numbers: RF0076695, RF9056277, RF9071611, RF9113177 and RF9127313;  c) Lot Numbers: RF0019576, RF0050476 and RF0063762; d) Lot Numbers: RF0018516, RF0022619, RF0035227, RF0062121, RF0076516, RF9015142, RF9028180, RF9057183, RF9086014, RF9109959, RF9114930 and RL8129036; e) Lot Numbers: RF0018444, RF0048049, RF0088324, RF8057019, RF8084220, RF8123782, RF9031837, RF9084607, RF9097370 and RF9101531;

10) a) Lot Numbers: RL8067536 and RL8088127; b) Lot Numbers: RF0019736 and RL8128948; c) Lot Numbers: RF0034516, RF0076550, RF8045507, RF8069628, RF8072014, RF8085134, RF8096832, RF8119796, RF9031152, RF9057640, RF9070896, RF9073140, RF9112779 and RF9126209;

11) Lot Number: RF9043945;

12) Lot Numbers: RF9068430 and RF9071290;

13) Lot Numbers: RF0035352, RF0062123 and RF9127596;

14) Lot Numbers: RL8067738 and RL8128952;

15) Lot Numbers: RF0018785, RF0034659, RF0062342, RF0087349, RF0088181, RF8096686, RF8109019, RF8110769, RF8123605, RF9015145, RF9028427, RF9056742, RF9068200, RF9072648, RF9097171 and RL8067689;

16) a) Lot Numbers: RF0019630, RF0035146, RF0062164, RF0063964, RF4121260, RF5012171, RF5022620, RF5022694, RF5022936, RF5023056, RF5043795, RF5044244, RF5054841, RF5060136, RF5072938, RF5083080, RF5084506, RF5095700, RF5106236, RF5118583, RF6012260, RF6022847, RF6033756, RF6034434, RF6035286, RF6057003, RF6068210, RF6070336, RF6080902, RF6081546, RF6093300, RF6104481, RF6115675, RF6116613, RF6127345, RF6127983, RF7018330, RF7020221, RF7032233, RF7054012, RF7054686, RF7065398, RF7076855, RF7077581, RF7088648, RF7089293, RF7090478, RF7101417, RF7112432, RF7113766, RF7124960, RF8015963, RF8020094, RF8029171, RF8031984, RF8033220, RF8044241, RF8045487, RF8056874, RF8057384, RF8068362, RF8071384, RF8083492, RF8085126, RF8096691, RF8109018, RF8110511, RF8110923, RF8123490, RF9015797, RF9027384, RF9028781, RF9030798, RF9044347, RF9056860, RF9057865, RF9060300, RF9071990, RF9101135, RF9112313, RF9112770, RF9114303 and RF9125231; b) Lot Numbers: RF0020943, RF0033155, RF0059261, RF0062162, RF0075661, RF8033219, RF8045501, RF8070634, RF8119793, RF8124055, RF9030633, RF9068315, RF9071039, RF9085981, RF9101233 and RF9126921; c) Lot Numbers: RF0021271, RF0035169, RF0059455, RF0062166, RF0076519, RF0087520, RF5012173, RF5012263, RF5022525, RF5022640, RF5022884, RF5033202, RF5043960, RF5044137, RF5044415, RF5054655, RF5055028, RF5060314, RF5072320, RF5084106, RF5095841, RF5106237, RF5107230, RF5118615, RF6011424, RF6012258, RF6022392, RF6033757, RF6034356, RF6045750, RF6057353, RF6057883, RF6068372, RF6068635, RF6070561, RF6079358, RF6080954, RF6081473, RF6082032, RF6093231, RF6104147, RF6116038, RF6116779, RF7018345, RF7020079, RF7029684, RF7031136, RF7031694, RF7042757, RF7043349, RF7054836, RF7066014, RF7066675, RF7077586, RF7088649, RF7089181, RF7090486, RF7101953, RF7102163, RF8015969, RF8016893, RF8029175, RF8031766, RF8033221, RF8044245, RF8045307, RF8057233, RF8068375, RF8072081, RF8083722, RF8097203, RF8107887, RF8111833, RF811833, RF9014775, RF9027307, RF9042699, RF9068374, RF9085995, RF9101133, RF9112853, RF9114302 and RF9125236; d) Lot Numbers: RF8029429, RF8031774, RF8043868 and RF8057234;

17) Lot Numbers: RF0017630, RF0021276, RF0047810, RF0075670, RF8045172, RF8045506, RF8056833, RF8069627, RF8071319, RF8110927, RF9015802, RF9030635, RF9056019, RF9068611, RF9071050, RF9086007, RF9097842, RF9100852 and RF9114874;

18) Lot Numbers: RF0010249, RF8045051, RF8072024, RF8095226, RF8096907, RF8107879, RF8110959, RF8119801, RF9014498, RF9028895, RF9060351, RL8067569 and RL8077782;

19) Lot Numbers: RF9044688, RF9057542, RL6123752, RL8118743, RL9019412, RL9029591 and RL9029591
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter dated October 29, 2010.
Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing. Firm initiated recall is ongoing.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
963,380 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1362-2011;

2) ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1363-2011;

3) ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1364-2011;

4) ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1365-2011;

5) ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished). A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1366-2011
CODE
1) Serial numbers: 09AGU111, 09AGU112, 09AGU113, 09AGU114, 09AGU115, 09AGU116, 08FGU100, 08FGU101, 08FGU102, 08FGU103, 08FGU104, 08FGU105, 08FGU106, 08FGU107, 08FGU108, 08FGU109, 08GGU001, 08GGU002, 08GGU003, 08GGU004, 08GGU005, 08GGU006, 08GGU007, 08GGU008, 08GGU009, 08GGU010, 08GGU011, 08GGU012, 08GGU013, 08GGU014, 08GGU015, 08GGU016, 08GGU017, 08GGU018, 08GGU019, 08GGU020, 08GGU021, 08GGU022, 08GGU023, 08GGU024, 08GGU025, 08GGU026, 08GGU027, 08GGU028, 08KGU071, 08KGU072, 08KGU073, 08KGU074, 08KGU075, 08KGU076, 08KGU077, 08KGU078, 08KGU079, 08KGU080, 08KGU081, 08KGU082, 08KGU083, 08KGU084, 08KGU085, 08KGU086, 08KGU087, 08KGU088, 08KGU089, 08KGU090, 08LGU001, 08LGU002, 08LGU003, 08LGU004, 08LGU005, 08LGU006, 08LGU007, 08LGU008, 08LGU009, 08LGU010, 08LGU011, 08LGU012, 08LGU013, 08LGU014, 08LGU015, 08LGU016, 08LGU017, 08LGU018, 08LGU019, 08LGU020, 09BGU081, 09BGU082, 09BGU083, 09BGU084, 09CGU001, 09CGU002, 09CGU003, 09CGU004, 09CGU005, 09CGU006, 09CGU007, 09CGU008, 09CGU009, 09CGU010, 09CGO090, 09CGU096, 09CGU097, 09CGU098, 09CGU099, 09CGU100, 09CGU101, 09CGU102, 09CGU103, 09CGU104, 09CGU105, 09CGU106, 09CGU107, 09CGU108, 09CGU109, 09CGU110, 09DGU031, 09DGU032, 09DGU033, 09DGU034, 09DGU035;

2) Serial numbers: 05KGU008, 05KGU010, 05KGU015, 05KGU012, 06BGU001, 06BGU004, 06BGU005, 06BGU006, 06BGU007, 06BGU008, 06BGU009, 06BGU010, 06BGU011, 06BGU012, 06BGU013, 06BGU014, 06BGU015, 06BGU016, 06BGU017, 06BGU019, 06BGU020, 06BGU021, 06BGU022, 06BGU023, 06BGU024, 06BGU025, 06BGU027, 06BGU029, 06BGU030, 06BGU031, 06BGU033, 06BGU034, 06BGU035, 06BGU036, 06BGU037, 06BGU038, 06BGU039, 06BGU040, 06BGU041, 06BGU042, 06BGU043, 06BGU044, 06BGU045, 06BGU046, 06BGU047, 06BGU048, 06BGU049, 06BGU050, 06CGU002, 06CGU003, 06CGU060, 06CGU062, 06CGU063, 06CGU064, 06CGU065, 06CGU066, 06CGU067, 06DGO018, 06DGU001, 06DGU002, 06DGU004, 06DGU005, 06DGU006, 06DGU007, 06DGU009, 06DGU010, 06DGU011, 06DGU012, 06DGU013, 06DGU014, 06DGU015, 06DGU016, 06DGU017, 06DGU018, 06DGU019, 06DGU020, 06DGU021, 06DGU023, 06DGU024, 06DGU025, 06DGU027, 06DGU028, 06DGU029, 06DGU030, 06DGU031, 06DGU032, 06DGU034, 06DGU035, 06DGU037, 06DGU038, 06DGU039, 06DGU040, 06E60041, 06E60056, 06E60057, 06EGU001, 06EGU002, 06EGU003, 06EGU004, 06EGU005, 06EGU006, 06EGU007, 06EGU009, 06EGU010, 06EGU011, 06EGU012, 06EGU013, 06EGU014, 06EGU015, 06EGU016, 06EGU017, 06EGU018, 06EGU019, 06EGU020, 06EGU021, 06EGU022, 06EGU023, 06EGU024, 06EGU025, 06EGU026, 06EGU027, 06EGU028, 06EGU029, 06EGU030, 06EGU031, 06EGU032, 06EGU033, 06EGU035, 06EGU037, 06EGU038, 06EGU039, 06EGU040, 06EGU041, 06EGU043, 06EGU044, 06EGU045, 06EGU046, 06EGU047, 06EGU048, 06EGU049, 06EGU050, 06EGU051, 06EGU052, 06EGU053, 06EGU054, 06EGU055, 06EGU056, 06EGU057, 06EGU058, 06EGU059, 06EGU060, 06EGU061, 06EGU062, 06EGU063, 06EGU064, 06EGU065, 06EGU066, 06EGU067, 06EGU068, 06EGU069, 06EGU070, 06EGU105, 06EGU106, 06EGU107, 06EGU108, 06EGU109, 06FGU001, 06FGU002, 06FGU003, 06FGU004, 06FGU005, 06FGU006, 06FGU007, 06FGU008, 06FGU009, 06FGU010, 06FGU011, 06FGU012, 06FGU013, 06FGU014, 06FGU016, 06FGU017, 06FGU018, 06FGU019, 06FGU020, 06FGU021, 06FGU022, 06FGU023, 06FGU024, 06FGU025, 06FGU026, 06FGU027, 06FGU031, 06FGU032, 06FGU033, 06FGU034, 06FGU035, 06FGU036, 06FGU037, 06FGU038, 06FGU039, 06FGU040, 06FGU042, 06FGU043, 06FGU044, 06FGU045, 06FGU046, 06FGU047, 06FGU048, 06FGU049, 06FGU050, 06FGU051, 06FGU052, 06FGU053, 06FGU054, 06FGU055, 06FGU056, 06FGU057, 06FGU058, 06FGU059, 06FGU060, 06FGU062, 06FGU063, 06FGU064, 06FGU065, 06FGU066, 06FGU067, 06FGU069, 06FGU070, 06FGU092, 06FGU093, 06FGU094, 06FGU095, 06FGU096, 06FGU097, 06FGU098, 06FGU028, 06FGU029, 06FGU030, 06FGU041, 06GGU001, 06GGU002, 06GGU003, 06GGU004, 06GGU005, 06GGU006, 06GGU007, 06GGU008, 06GGU009, 06GGU010, 06GGU012, 06GGU013, 06GGU014, 06GGU015, 06GGU016, 06GGU017, 06GGU019, 06GGU020, 06GGU021, 06GGU022, 06GGU023, 06GGU024, 06GGU026, 06GGU028, 06GGU029, 06GGU030, 06GGU031, 06GGU032, 06GGU033, 06GGU034, 06GGU036, 06GGU037, 06GGU038, 06GGU039, 06GGU040, 06GGU051, 06GGU053, 06GGU054, 06GGU055, 06GGU056, 06GGU057, 06GGU058, 06GGU059, 06GGU060, 06GGU061, 06GGU062, 06GGU063, 06GGU064, 06GGU065, 06GGU066, 06GGU067, 06GGU068, 06GGU069, 06GGU070, 06HGU001, 06HGU002, 06HGU003, 06HGU004, 06HGU006, 06HGU007, 06HGU008, 06HGU009, 06HGU010, 06HGU011, 06HGU012, 06HGU013, 06HGU014, 06HGU015, 06HGU016, 06HGU017, 06HGU018, 06HGU019, 06HGU020, 06HGU021, 06HGU022, 06HGU023, 06HGU024, 06HGU026, 06HGU027, 06HGU028, 06HGU029, 06HGU030, 06HGU031, 06HGU032, 06HGU033, 06HGU034, 06HGU035, 06HGU036, 06HGU037, 06HGU038, 06HGU039, 06HGU040, 06HGU041, 06HGU042, 06HGU043, 06HGU044, 06HGU045, 06HGU046, 06HGU047, 06HGU048, 06HGU049, 06HGU050, 06HGU051, 06HGU052, 06HGU053, 06HGU054, 06HGU055, 06HGU056, 06HGU057, 06HGU058, 06HGU059, 06HGU060, 06HGU081, 06HGU082, 06HGU083, 06HGU084, 06HGU085, 06HGU086, 06HGU087, 06HGU088, 06HGU089, 06HGU090, 06HGU091, 06HGU092, 06HGU093, 06HGU094, 06HGU096, 06HGU097, 06HGU098, 06HGU099, 06JGU001, 06JGU002, 06JGU003, 06JGU004, 06JGU005, 06JGU006, 06JGU007, 06JGU008, 06JGU012, 06JGU013, 06JGU015, 06JGU016, 06JGU017, 06JGU018, 06JGU020, 06JGU021, 06JGU022, 06JGU023, 06JGU024, 06JGU025, 06JGU026, 06JGU027, 06JGU028, 06JGU029, 06JGU030, 06JGU031, 06JGU032, 06JGU033, 06JGU034, 06JGU035, 06JGU036, 06JGU037, 06JGU038, 06JGU039, 06JGU040, 06JGU041, 06JGU042, 06JGU043, 06JGU044, 06JGU045, 06JGU046, 06JGU047, 06JGU048, 06JGU049, 06JGU050, 06JGU051, 06JGU052, 06JGU053, 06JGU054, 06JGU055, 06JGU056, 06JGU057, 06JGU058, 06JGU059, 06JGU060, 06JGU061, 07DGU031, 07DGU032, 07DGU033, 07DGU034, 07DGU035, 07DGU036, 07DGU037, 07DGU038, 07DGU039, 07DGU040, 07DGU041, 07DGU042, 07DGU043, 07DGU044, 07DGU045, 07DGU046, 07DGU047, 07DGU048, 07DGU049, 07DGU050, 07DGU051, 07DGU052, 07DGU053, 07DGU054, 07DGU055, 07DGU056, 07DGU057, 07DGU058, 07EGU001, 07EGU002, 07EGU003, 07EGU004, 07EGU005, 07EGU006, 07EGU007, 07EGU008, 07EGU009, 07EGU011, 07EGU012, 07EGU013, 07EGU014, 07EGU016, 07EGU020, 07EGU021, 07EGU022, 07EGU024, 07EGU025, 07EGU026, 07EGU027, 07EGU028, 07EGU029, 07EGU030, 07EGU031, 07EGU032, 07EGU033, 07EGU034, 07EGU035, 07EGU036, 07EGU037, 07EGU038, 07EGU040, 07EGU041, 07EGU042, 07EGU043, 07EGU044, 07EGU045, 07EGU046, 07EGU047, 07EGU048, 07EGU049, 07EGU052, 07EGU053, 07EGU054, 07EGU055, 07EGU057, 07EGU058, 07EGU059, 07EGU060, 07EGU081, 07EGU083, 07EGU084, 07EGU085, 07EGU086, 07EGU087, 07EGU088, 07EGU089, 07EGU090, 07EGU091, 07EGU092, 07EGU093, 07EGU094, 07EGU095, 07EGU096, 07EGU097, 07EGU098, 07EGU099, 07EGU100, 07JGU008, 07FGU021, 07FGU022, 07FGU023, 07FGU024, 07FGU025, 07FGU026, 07FGU027, 07FGU028, 07FGU029, 07FGU030, 07FGU031, 07FGU032, 07FGU033, 07FGU034, 07FGU035, 07FGU036, 07FGU037, 07FGU038, 07FGU039, 07FGU040, 07FGU041, 07FGU042, 07FGU043, 07FGU044, 07FGU045, 07FGU046, 07FGU047, 07FGU048, 07FGU049, 07FGU050, 07FGU051, 07FGU052, 07FGU053, 07FGU054, 07FGU055, 07FGU056, 07FGU057, 07FGU058, 07FGU059, 07FGU060, 07FGU061, 07FGU062, 07FGU063, 07FGU064, 07FGU065, 07FGU066, 07FGU067, 07FGU068, 07FGU069, 07FGU070, 07GGU011, 07GGU012, 07GGU013, 07GGU014, 07GGU015, 07GGU016, 07GGU017, 07GGU018, 07GGU021, 07GGU022, 07GGU023, 07GGU024, 07GGU025, 07GGU026, 07GGU027, 07GGU028, 07GGU029, 07GGU030, 07GGU031, 07GGU032, 07GGU033, 07GGU034, 07GGU035, 07GGU036, 07GGU037, 07GGU038, 07GGU040, 07GGU041, 07GGU042, 07GGU043, 07GGU044, 07GGU045, 07GGU046, 07GGU047, 07GGU048, 07GGU049, 07GGU050, 07HGU001, 07HGU002, 07HGU003, 07HGU004, 07HGU005, 07HGU006, 07HGU007, 07HGU008, 07HGU009, 07HGU010, 07HGU019, 07HGU020, 07HGU022, 07HGU023, 07HGU024, 07HGU025, 07HGU026, 07HGU027, 07HGU028, 07HGU029, 07HGU030, 07HGU032, 07HGU033, 07HGU034, 07HGU035, 07HGU036, 07HGU037, 07HGU038, 07HGU039, 07HGU040, 07HGU042, 07HGU043, 07HGU044, 07HGU045, 07HGU046, 07HGU072, 07JGU003, 07JGU007, 07JGU009, 07JGU010, 07JGU012, 07JGU013, 07JGU014, 07JGU015, 07JGU016, 07JGU017, 07JGU018, 07JGU019, 07JGU020, 07JGU021, 07JGU022, 07JGU023, 07JGU024, 07JGU025, 07JGU026, 07JGU027, 07JGU028, 07JGU029, 07JGU030, 07JGU031, 07JGU032, 07JGU033, 07JGU034, 07JGU036, 07JGU037, 07JGU038, 07JGU039, 07JGU040, 07LGU021, 07LGU022, 07LGU023, 07LGU024, 07LGU025, 07LGU026, 07LGU027, 07LGU028, 07LGU029, 07LGU030, 07LGU031, 07LGU032, 07MGU011, 07MGU012, 07MGU013, 07MGU014, 07MGU015, 07MGU016, 07MGU017, 07MGU018, 07MGU019, 07MGU020, 08AGU001, 08AGU004, 08AGU006, 08AGU010, 08AGU011, 08AGU013, 08AGU014, 08AGU015, 08AGU016, 08AGU017, 08AGU018, 08AGU019, 08AGU020, 08AGU021, 08AGU023, 08AGU024, 08AGU025, 08AGU026, 08AGU027, 08AGU028, 08AGU029, 08AGU030, 08AGU071, 08AGU072, 08AGU073, 08AGU074, 08AGU075, 08AGU076, 08AGU077, 08AGU078, 08AGU079, 08AGU080, 08AGU081, 08AGU082, 08AGU083, 08AGU084, 08AGU085, 08AGU086, 08AGU087, 08AGU088, 08AGU089, 08AGU090, 08AGU091, 08AGU092, 08AGU093, 08AGU094, 08AGU095, 08AGU096, 08AGU097, 08AGU098, 08AGU099, 08AGU100, 09BGU004, 08BGU031, 08BGU032, 08BGU033, 08BGU034, 08BGU035, 08BGU037, 08BGU038, 08BGU039, 08BGU040, 08BGU041, 08BGU042, 08BGU043, 08BGU044, 08BGU045, 08BGU046, 08BGU047, 08BGU048, 08BGU049, 08BGU050, 08BGU051, 08BGU052, 08BGU053, 08BGU054, 08BGU055, 08BGU056, 08BGU057, 08BGU058, 08BGU059, 08BGU060, 08CGU012, 08CGU015, 08CGU016, 08CGU017, 08CGU018, 08CGU022, 08CGU024, 08CGU025, 08CGU026, 08CGU028, 08CGU029, 08CGU030, 08CGU061, 08CGU062, 08CGU063, 08CGU064, 08CGU065, 08CGU066, 08CGU067, 08CGU068, 08CGU069, 08CGU070, 08CGU071, 08CGU072, 08CGU073, 08CGU076, 08CGU077, 08CGU078, 08CGU079, 08CGU080, 08CGU081, 08CGU082, 08CGU083, 08DGU001, 08DGU002, 08DGU003, 08DGU004, 08DGU005, 08DGU006, 08DGU007, 08DGU020, 08DGU025, 08DGU026, 08DGU027, 08DGU028, 08DGU029, 08DGU030, 08DGU031, 08DGU032, 08DGU033, 08DGU034, 08DGU035, 08DGU036, 08DGU037, 08DGU038, 08DGU039, 08DGU040, 08DGU081, 08DGU082, 08DGU083, 08DGU084, 08DGU085, 08DGU086, 08DGU087, 08DGU089, 08DGU088, 08EGU001, 08EGU002, 08EGU003, 08EGU004, 08EGU005, 08EGU006, 08EGU007, 08EGU008, 08EGU009, 08EGU010, 08EGU011, 08EGU012, 08EGU014, 08EGU015, 08EGU017, 08EGU018, 08EGU019, 08EGU020, 08EGU021, 08EGU022, 08EGU023, 08EGU024, 08EGU025, 08EGU026, 08EGU027, 08EGU028, 08EGU029, 08EGU030, 08EGU031, 08EGU033, 08EGU034, 08EGU035, 08EGU037, 08EGU016, 08FGU002, 08FGU003, 08FGU004, 08FGU005, 08FGU006, 08FGU007, 08FGU008, 08FGU009, 08FGU010, 08FGU011, 08FGU012, 08FGU013, 08FGU014, 08FGU015, 08FGU016, 08FGU017, 08FGU018, 08FGU019, 08FGU020, 08FGU021, 08FGU022, 08FGU023, 08FGU024, 08FGU026, 08FGU027, 08FGU028, 08FGU029, 08FGU030, 08FGU031, 08GGU033, 08GGU035, 08GGU037, 08GGU038, 08GGU039, 08GGU040, 08GGU041, 08GGU042, 08GGU043, 08GGU044, 08GGU045, 08GGU046, 08GGU047, 08GGU048, 08GGU049, 08GGU050, 08GGU051, 08GGU052, 08GGU053, 08GGU054, 08GGU055, 08GGU056, 08GGU057, 08GGU058, 08GGU059, 08GGU060, 08GGU070, 08GGU032, 08GGU034, 08GGU036, 08GGU061, 08GGU062, 08GGU063, 08GGU064, 08GGU065, 08GGU066, 08GGU067, 08GGU068, 08HGU001, 08HGU002, 08HGU005, 08HGU006, 08HGU008, 08HGU009, 08HGU010, 08HGU011, 08HGU012, 08HGU015, 08HGU018, 08HGU019,

08HGU020, 08HGU028, 08HGU029, 08HGU030, 08HGU032, 08HGU033, 08HGU034, 08HGU003, 08HGU004, 08HGU013, 08HGU014, 08HGU016, 08HGU017, 08HGU021, 08HGU022, 08HGU023, 08HGU024, 08HGU025, 08HGU026, 08HGU027, 08HGU031, 08JGU011, 08JGU012, 08JGU014, 08JGU015, 08JGU021, 08JGU022, 08JGU023, 08JGU024, 08JGU025, 08JGU027, 08JGU028, 08JGU029, 08JGU030, 08JGU031, 08JGU034, 08JGU035, 08JGU036, 08LGU058, 08JGU016, 08JGU017, 08JGU018, 08JGU019, 08JGU020, 08JGU026, 08JGU032, 08JGU033, 08KGU001, 08KGU002, 08KGU003, 08KGU004, 08KGU005, 08KGU006, 08KGU007, 08KGU008, 08KGU009, 08KGU010, 08KGU011, 08KGU012, 08KGU013, 08KGU014, 08KGU015, 08KGU016, 08KGU017, 08KGU018, 08KGU019, 08KGU024, 08KGU025, 08KGU026, 08KGU028, 08KGU030, 08KGU031, 08KGU032, 08KGU034, 08KGU020, 08KGU021, 08KGU022, 08KGU023, 08KGU027, 08KGU029, 08KGU033, 08LGU021, 08LGU022, 08LGU023, 08LGU024, 08LGU025, 08LGU026, 08LGU027, 08LGU028, 08LGU029, 08LGU030, 08LGU031, 08LGU033, 08LGU034, 08LGU035, 08LGU056, 08LGU057, 08LGU059, 08LGU060, 08MGU001, 08MGU002, 08MGU003, 08MGU004, 08MGU005, 08MGU006, 08MGU007, 08MGU008, 08MGU009, 08MGU010, 08MGU011, 08MGU014, 08MGU015, 08MGU016, 08MGU017, 08MGU018, 08MGU019, 08MGU020, 08MGU021, 08MGU022, 08MGU024, 08MGU027, 08MGU028, 08MGU029, 08MGU030, 08MGU031, 08MGU032, 08MGU033, 08MGU036, 08MGU037, 08MGU038, 08MGU039, 08MGU040, 08MGU081, 08MGU082, 08MGU083, 08MGU084, 08MGU085, 08MGU086, 08MGU087, 08MGU088, 08MGU089, 08MGU090, 08MGU091, 08MGU092, 08MGU093, 08MGU094, 08MGU095, 08MGU096, 09HGU030, 09AGU001, 09AGU002, 09AGU004, 09AGU005, 09AGU006, 09AGU007, 09AGU008, 09AGU009, 09AGU011, 09AGU012, 09AGU013, 09AGU014, 09AGU015, 09AGU016, 09AGU017, 09BGU003, 09BGU006, 09BGU007, 09BGU008, 09BGU009, 09BGU010, 09BGU011, 09BGU012, 09BGU013, 09BGU014, 09BGU015, 09BGU016, 09BGU017, 09BGU018, 09BGU019, 09BGU020, 09BGU021, 09BGU022, 09BGU023, 09BGU024, 09BGU025, 09BGU027, 09BGU028, 09BGU029, 09BGU002, 09BGU005, 09CGU012, 09CGU013, 09CGU014, 09CGU015, 09CGU016, 09CGU011, 09CGU017, 09DGU005, 09DGU006, 09DGU007, 09DGU008, 09DGU009, 09DGU010, 09DGU011, 09DGU012, 09DGU013, 09DGU014, 09DGU015, 09DGU016, 09DGU017, 09DGU018, 09DGU019, 09DGU020, 09DGU021, 09DGU022, 09DGU023, 09DGU024, 09DGU025, 09DGU026, 09DGU027, 09DGU028, 09DGU029, 09DGU030, 09DGU081, 09DGU082, 09DGU083, 09DGU084, 09DGU085, 09DGU086, 09DGU087, 09DGU088, 09DGU089, 09DGU090, 09DGU094, 09DGU095, 09DGU096, 09DGU097, 09DGU099, 09DGU100, 09DGU001, 09DGU002, 09DGU003, 09DGU004, 09DGU091, 09DGU092, 09DGU093, 09EGU011, 09EGU012, 09EGU013, 09EGU014, 09EGU015, 09EGU016, 09EGU017, 09EGU018, 09EGU019, 09EGU020, 09EGU021, 09EGU022, 09EGU023, 09EGU024, 09EGU025, 09EGU026, 09EGU027, 09EGU028, 09FGU031, 09FGU032, 09FGU033, 09FGU034, 09FGU035, 09FGU036, 09FGU037, 09FGU038, 09FGU039, 09FGU040, 09GGU011, 09GGU012, 09GGU013, 09GGU014, 09GGU015, 09GGU016, 09GGU017, 09GGU018, 09GGU019, 09GGU020, 09GGU021, 09GGU022, 09GGU023, 09GGU024, 09GGU025, 09GGU026, 09GGU027, 09GGU028, 09GGU029, 09GGU030, 09GGU031, 09GGU032, 09GGU033, 09GGU034, 09GGU035, 09GGU036, 09GGU037, 09GGU038, 09GGU039, 09GGU040;

3) Serial Numbers: 05KGU014, 06CGU009, 06CGU010, 06CGU011, 06CGU012, 06CGU013, 06CGU014, 06CGU015, 06CGU016, 06CGU017, 06CGU018, 06CGU019, 06CGU020, 06CGU021, 06CGU022, 06CGU023, 06CGU024, 06CGU025, 06CGU026, 06CGU027, 06CGU028, 06CGU029, 06CGU030, 06CGU031, 06CGU032, 06CGU033, 06DGU041, 06DGU042, 06DGU043, 06DGU044, 06DGU045, 06DGU046, 06DGU047, 06DGU048, 06DGU049, 06DGU050, 06DGU051, 06DGU052, 06DGU053, 06DGU054, 06DGU055, 06DGU056, 06DGU057, 06DGU058, 06DGU059, 06DGU060, 06FGU071, 06FGU072, 06FGU073, 06FGU074, 06FGU075, 06FGU076, 06FGU077, 06FGU078, 06FGU079, 06FGU080, 06LGU011, 06LGU012, 06LGU013, 06LGU014, 06LGU015, 06LGU016, 06MGU017, 06MGU018, 06MGU019, 06MGU020, 07AGU001, 07AGU002, 07AGU003, 07AGU004, 07AGU005, 07AGU006, 07AGU007, 07AGU008, 07AGU009, 07AGU010, 07AGU011, 07AGU012, 07AGU013, 07AGU014, 07AGU015, 07AGU016, 07AGU017, 07AGU018, 07AGU019, 07AGU020, 07AGU021, 07AGU022, 07AGU023, 07AGU024, 07AGU025, 07AGU026, 07AGU027, 07AGU028, 07AGU029, 07AGU030, 07CGU001, 07CGU002, 07CGU003, 07CGU004, 07CGU005, 07CGU006, 07CGU008, 07CGU009, 07CGU010, 07CGU011, 07CGU012, 07CGU013, 07CGU014, 07CGU015, 07CGU016, 07CGU017, 07CGU018, 07DGU001, 07DGU002, 07DGU003, 07DGU004, 07DGU005, 07DGU006, 07DGU007, 07DGU008, 07DGU009, 07DGU010, 07DGU011, 07DGU012, 07DGU013, 07DGU014, 07DGU015, 07DGU017, 07DGU018, 07DGU019, 07DGU020, 07DGU021, 07DGU022, 07DGU023, 07DGU024, 07DGU025, 07DGU026, 07DGU027, 07DGU028, 07DGU029, 07DGU030, 07EGU063, 07EGU064, 07EGU065, 07EGU066, 07EGU067, 07EGU068, 07EGU069, 07EGU070, 07FGU001, 07FGU002, 07FGU003, 07FGU004, 07FGU005, 07FGU006, 07FGU007, 07FGU008, 07FGU009, 07FGU010, 07FGU011, 07FGU012, 07FGU013, 07FGU014, 07FGU015, 07FGU016, 07FGU017, 07FGU018, 07FGU019, 07FGU020, 07GGU051, 07GGU052, 07GGU053, 07GGU054, 07GGU055, 07GGU056, 07GGU057, 07GGU059, 07GGU060, 07JGU041, 07JGU042, 07JGU043, 07JGU044, 07JGU045, 07JGU046, 07JGU047, 07JGU049, 07JGU050, 07KGU001, 07KGU002, 07KGU003, 07KGU004, 07KGU005, 07KGU006, 07KGU007, 07KGU008, 07KGU009, 07KGU010, 07KGU011, 07KGU012, 07KGU013, 07KGU014, 07KGU015, 07KGU016, 07KGU017, 07KGU018, 07KGU019, 07KGU020, 07LGU001, 07LGU002, 07LGU003, 07LGU004, 07LGU005, 07LGU006, 07LGU007, 07LGU008, 07LGU009, 07LGU010, 08AGU041, 08BGU016, 08BGU018, 08BGU019, 08BGU020, 08BGU021, 08BGU022, 08BGU023, 08BGU024, 08BGU025, 08DGU041, 08DGU042, 08DGU043, 08DGU044, 08DGU045, 08DGU047, 08EGU041, 08EGU042, 08EGU043, 08EGU044, 08EGU045, 08EGU046, 08EGU047, 08EGU048, 08EGU049, 08EGU050, 08EGU051, 08EGU052, 08EGU053, 08EGU054, 08EGU055, 08EGU056, 08EGU057, 08EGU058, 08EGU059, 08EGU060, 08EGU061, 08EGU062, 08EGU063, 08EGU064, 08EGU065, 08EGU066, 08EGU067, 08EGU068, 08GGU071, 08GGU072, 08GGU073, 08GGU074, 08GGU075, 08GGU076, 08GGU077, 08GGU078, 08GGU079, 08GGU080, 08HGU041, 08HGU042, 08HGU043, 08HGU044, 08HGU045, 08HGU046, 08HGU047, 08HGU048, 08HGU049, 08HGU050, 08HGU051, 08HGU052, 08HGU053, 08HGU054, 08HGU055, 08HGU056, 08JGU041, 08JGU042, 08JGU043,08JGU044, 08JGU045, 08JGU046, 08JGU047, 08JGU048, 08JGU049, 08JGU050, 08JGU51, 08JGU052, 08JGU053, 08JGU054, 08JGU055, 08JGU056, 08JGU057, 08JGU058, 08JGU059, 08JGU060, 08KGU041, 08KGU042, 08KGU043, 08KGU044, 08KGU045, 08KGU046, 08KGU047, 08KGU048, 08KGU049, 08KGU050, 08KGU051, 08MGU041, 08MGU042, 08MGU043, 08MGU044, 08MGU045, 09AGU042, 09AGU043, 09AGU044, 09AGU045, 09AGU046, 09AGU046, 09AGU047, 09AGU048, 09AGU049, 09AGU050, 09AGU051, 09AGU052, 09AGU053, 09AGU054, 09AGU055, 09AGU056, 09AGU057, 09AGU058, 09AGU059, 09AGU060, 09AGU081, 09AGU082, 09AGU083, 09AGU084, 09AGU085, 09AGU086, 09AGU087, 09AGU088, 09AGU089, 09AGU090, 09AGU091, 09AGU091, 09AGU092, 09AGU093, 09AGU094, 09AGU095, 09AGU096, 09AGU097, 09AGU098, 09AGU099, 09AGV100, 09BGU042, 09BGU043, 09BGU044, 09BGU045, 09BGU046, 09BGU047, 09BGU048, 09BGU049, 09BGU050, 09BGU051, 09BGU052, 09BGU053, 09BGU054, 09BGU055, 09BGU056, 09BGU057, 09BGU058, 09BGU059, 09BGU060, 09BGU091, 09BGU092, 09BGU093, 09BGU094, 09BGU095, 09BGU096, 09BGU097, 09BGU098, 09BGU099, 09CGU051, 09CGU052, 09CGU053, 09CGU054, 09CGU055, 09CGU056, 09CGU057, 09CGU058, 09CGU059, 09DGU041, 09DGU042, 09DGU043, 09DGU044, 09DGU045, 09DGU046, 09DGU047, 09DGU048, 09DGU049, 09DGU050, 09DGU051, 09DGU052, 09DGU053, 09DGU054, 09DGU055, 09DGU056, 09DGU057, 09DGU058, 09DGU059, 09DGU060, 09EGU041, 09EGU042, 09EGU043, 09EGU044, 09EGU045, 09EGU046, 09EGU047, 09EGU048, 09EGU049, 09EGU050, 09EGU051, 09EGU052, 09EGU053, 09EGU054, 09EGU055, 09EGU056, 09EGU057, 09EGU058, 09EGU059, 09EGU060, 09EGU061, 09EGU062, 09EGU063, 09EGU094, 09GGU041, 09GGU042, 09GGU043, 09GGU044, 09GGU045, 09GGU046, 09GGU047, 09GGU048, 09GGU049, 09GGU050, 09GGU051, 09GGU052, 09GGU053, 09GGU054, 09GGU055, 09GGU056, 09GGU057, 09GGU058, 09GGU059, 09GGU060 09GGU061;

4) Serial numbers: 05KGU013, 06CGU036, 06CGU001, 06CGU034, 06CGU035, 06CGU037, 06CGU038, 06CGU039, 06CGU040, 06CGU042, 06CGU043, 06CGU044, 06CGU045, 06CGU046, 06CGU047, 06CGU048, 06CGU049, 06CGU050, 06CGU051, 06CGU052, 06CGU053, 06CGU054, 06CGU055, 06CGU056, 06CGU057, 06CGU058, 06CGU059, 06DGU061, 06DGU062, 06DGU063, 06DGU064, 06DGU065, 06DGU066, 06DGU067, 06DGU068, 06DGU069, 06EGU081, 06EGU082, 06EGU083, 06EGU084, 06EGU085, 06EGU086, 06EGU087, 06EGU088, 06EGU089, 06EGU090, 06EGU091, 06EGU092, 06EGU093, 06EGU094, 06EGU095, 06EGU096, 06EGU097, 06EGU098, 06EGU099, 06EGU100, 06FGU081, 06FGU084, 06FGU085, 06FGU086, 06FGU087, 06FGU088, 06FGU089, 06FGU090, 06LGU001, 06LGU002, 06LGU003, 06LGU004, 06LGU005, 06LGU006, 06LGU007, 06LGU010, 06LGU008, 06LGU009, 06MGU026, 06MGU027, 06MGU028, 06MGU029, 06MGU030, 06MGU031, 06MGU032, 06MGU033, 06MGU034, 06MGU035, 07AGU031, 07AGU032, 07AGU033, 07AGU034, 07AGU035, 07AGU036, 07AGU037, 07AGU038, 07AGU039, 07AGU040, 07AGU041, 07AGU042, 07AGU043, 07AGU044, 07AGU045, 07AGU046, 07AGU047, 07AGU048, 07AGU049, 07HGU052, 07FGU071, 07FGU072, 07FGU073, 07FGU074, 07FGU075, 07FGU076, 07FGU077, 07FGU078, 07FGU079, 07FGU080, 07GGU001, 07GGU002, 07GGU003, 07GGU004, 07GGU005, 07GGU006, 07GGU007, 07GGU008, 07GGU009, 07GGU010, 07HGU051, 07HGU053, 07HGU054, 07HGU055, 07HGU056, 07HGU057, 07HGU058, 07HGU059, 07HGU060, 07HGU061, 07HGU062, 07HGU063, 07HGU064, 07HGU065, 07HGU066, 07HGU067, 07HGU068, 07HGU069, 07HGU070, 07HGU071, 07HGU073, 07JGU051, 07JGU052, 07JGU053, 07JGU054, 07JGU055, 07JGU056, 07JGU057, 07KGU021, 07KGU022, 07KGU023, 07KGU024, 07KGU025, 07KGU026, 07KGU027, 07KGU028, 07KGU029, 07KGU030, 07KGU031, 07KGU032, 07KGU033, 07KGU034, 07KGU035, 07KGU036, 07KGU037, 07KGU038, 07KGU039, 07LGU011, 07LGU012, 07LGU013, 07LGU014, 07LGU015, 07LGU016, 07LGU017, 07LGU018, 07LGU019, 07LGU020, 07MGU021, 07MGU022, 07MGU023, 07MGU024, 07MGU025, 07MGU026, 07MGU028, 07MGU029, 07MGU030, 08AGU051, 08AGU052, 08AGU053, 08AGU054, 08AGU055, 08AGU056, 08AGU057, 08AGU058, 08AGU059, 08AGU060, 08BGU001, 08BGU002, 08BGU003, 08BGU004, 08BGU005, 08BGU006, 08BGU007, 08BGU008, 08BGU009, 08BGU010, 08BGU011, 08BGU012, 08BGU013, 08BGU014, 08BGU015, 08CGU046, 08CGU047, 08CGU048, 08CGU049, 08CGU050, 08CGU051, 08CGU052, 08CGU053, 08CGU054, 08CGU055, 08CGU056, 08CGU057, 08CGU058, 08CGU059, 08CGU060, 08CGU091, 08CGU092, 08CGU093, 08CGU094, 08CGU095, 08CGU096, 08CGU097, 08CGU098, 08CGU099, 08DGU061, 08DGU062, 08DGU063, 08DGU064, 08DGU065, 08DGU066, 08DGU067, 08DGU068, 08DGU069, 08DGU070, 08DGU071, 08DGU072, 08DGU073, 08DGU074, 08DGU075, 08DGU076, 08DGU077, 08DGU078, 08EGU071, 08EGU072, 08EGU073, 08FGU062, 08FGU063, 08FGU064, 08FGU065, 08FGU066, 08FGU067, 08FGU069, 08FGU070, 08FGU071, 08FGU072, 08FGU073, 08FGU074, 08FGU075, 08FGU076, 08FGU077, 08FGU078, 08FGU079, 08FGU080, 08GGU091, 08GGU092, 08GGU093, 08GGU094, 08GGU095, 08GGU096, 08GGU097, 08GGU098, 08GGU099, 08GGU100, 08HGU061, 08HGU062, 08HGU063, 08HGU064, 08HGU065, 08HGU066, 08HGU067, 08HGU068, 08HGU069, 08HGU070, 08HGU071, 08HGU072, 08JGU061, 08JGU062, 08JGU063, 08JGU064, 08JGU065, 08KGU061, 08KGU062, 08KGU063, 08KGU064, 08KGU065, 08KGU066, 08KGU067, 08KGU068, 08KGU069, 08KGU070, 09KGU072, 08KGU091, 08KGU092, 08KGU093, 08KGU094, 08KGU095, 08KGU096, 08KGU097, 08KGU098, 08KGU099, 08KGU100, 08MGU061, 08MGU062, 08MGU063, 08MGU064, 08MGU065, 08MGU066, 08MGU067, 08MGU068, 08MGU069, 08MGU070, 08MGU071, 08MGU072, 08MGU073, 08MGU074, 08MGU075, 09AGU061, 09AGU062, 09AGU063, 09AGU064, 09AGU065, 09AGU066, 09AGU067, 09AGU068, 09AGU069, 09AGU071, 09AGU072, 09AGU074, 09AGU075, 09AGU076, 09AGU73, 09BGU061, 09BGU062, 09BGU063, 09BGU064, 09BGU065, 09CGU076, 09CGU077, 09CGU078, 09CGU079, 09CGU080, 09CGU081, 09CGU082, 09CGU083, 09CGU084, 09CGU085, 09CGU086, 09CGU087, 09CGU088, 09CGU089, 09CGU090, 09CGU091, 09CGU092, 09CGU093, 09CGU094, 09CGU095, 09CGU111, 09CGU112, 09CGU113, 09CGU114, 09DGU061, 09DGU062, 09DGU063, 09DGU064, 09DGU066, 09DGU067, 09DGU068, 09DGU069, 09DGU070, 09DGU071, 09DGU072, 09DGU073, 09DGU074, 09DGU075, 09DGU076, 09DGU077, 09DGU078, 09DGU079, 09DGU080, 09DGU101, 09DGU102, 09DGU103, 09DGU104, 09GGU084, 09GGU081, 09GGU083, 09GGU085, 09GGU086, 09GGU087, 09GGU088, 09GGU089, 09GGU090, 09GGU091, 09GGU092, 09GGU093, 09GGU094, 09GGU095, 09GGU096, 09GGU097, 09GGU098, 09GGU100, 09GGU102, 09GGU103, 09GGU104, 09GGU105, 09GGU106, 09GGU107, 09GGU108, 09GGU109, 09GGU110, 09GGU111, 09GGU112, 09GGU113, 09GGU114, 09GGU115, 09GGU116, 09GGU117;

5) Serial numbers: 05KGU008, 05KGU012, 06BGU004, 06BGU011, 06BGU013, 06BGU016, 06BGU025, 06DGU005, 06DGU015, 06DGU038, 06EGU026, 06EGU027, 06EGU035, 06EGU105, 06EGU106, 06EGU142, 06FGU008, 06FGU014, 06FGU067, 06GGU015, 06GGU057, 06JGU047, 07DGU031, 07DGU036, 07DGU037, 07DGU041, 08CGU061, 08CGU062, 08CGU073
RECALLING FIRM/MANUFACTURER
ConMed Electrosurgery, Centennial, CO, by letter dated December 27, 2010. Firm initiated recall is ongoing.
REASON
Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
VOLUME OF PRODUCT IN COMMERCE
2,323 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): a) A0030/1; b) A0031/1; c) A0032/1; d) A0033/1, Cardio Life Research S.A., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery. Recall # Z-1370-2011
CODE
a) Batch #: 32730001, 32765005, 33253005, 347830070; b) 32730003, 32765007, 347830080, 33253006; c) 32730002, 32765006, 34783090, 32985001; d) 32765008, 33253007, 347830100
RECALLING FIRM/MANUFACTURER
St. Jude Medical Cardiovascular Division, Minnetonka, MN, by letter dated January 26, 2011. Firm initiated recall is ongoing.
REASON
St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may be undetectable prior to use, there is a potential for them to detach during product use, enter the systemic circulation , and possibly lead to distal vessel micro-embolization. To date, there have been no reports of this event occurring and no adverse event related to this issue have been reported to St. Jude Medical.
VOLUME OF PRODUCT IN COMMERCE
450 units
DISTRIBUTION
Nationwide, Belgium, France, Germany, Switzerland, and United Kingdom

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS III
___________________________________
PRODUCT
Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Recall # Z-1342-2011
CODE
Lot Numbers: 70200185; Lot Numbers: 70200185, AA00190
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated March 24, 2010. Firm initiated recall is ongoing.
REASON
The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
VOLUME OF PRODUCT IN COMMERCE
48 kits
DISTRIBUTION
Nationwide and Italy

END OF ENFORCEMENT REPORT FOR FEBRUARY 23, 2011

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