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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 7 2012

 

March 7, 2012                                                                                                   12-10
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Mellace Family Brands raw Organic Cashews. 320. Net Weight 25 lbs. PT. Java Mete Indonesia, Certified Organic by Organic Certifiers, Export Quality. Recall # F-0826-2012
CODE
Lot #: USGE19387
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by telephone and e-mail on January 23, 2012, and by letter dated February 1, 2012.
Manufacturer: PT. JAVA Mete Indonesia, Semarang, Indonesia. Firm initiated recall is ongoing.
REASON
The product was found to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
225 x 2/25 lb boxes
DISTRIBUTION
CA, MI, OR
___________________________________
PRODUCT
Herring in Vegetable Oil Filling; UPC 4 605390 003400. The processed fish is packaged in a 49.38 oz. plastic tub. Recall # F-0827-2012
CODE
Best before date codes of 06.04.2011 and 09.06.2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal Sweet Bakery, Inc., Brooklyn, NY, by press release on April 18, 2011.
Manufacturer: Marina, LTD, Moscovskaya Oblast, Russia. New York initiated recall is complete.
REASON
The product was found to be improperly eviscerated based on samplings and analyses by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
149 cases (3 plastic tubs per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) The Farmers Market, Iceberg, Shredded, Crisp Shredded Iceberg Lettuce, 8 oz package, UPC 3003430195. Recall # F-0830-2012;
 
2) The Farmers Market, Parisian Blend, 7 oz package, UPC 3003430259. Recall # F-0831-2012;
 
3) The Farmers Market, Leafy Romaine, 9 oz package, UPC 3003430364. Recall # F-0832-2012;
 
4) The Farmers Market, Romaine Garden, 12 oz package, UPC 3003430220. Recall # F-0833-2012;
 
5) Giant Eagle Italian Sandwich Ring, Large, UPC 23755100000. Recall # F-0834-2012;
 
6) Giant Eagle Mini Italian Sandwich Ring, UPC 24755500000. Recall # F-0835-2012;
 
7) Giant Eagle Large New York Sandwich Ring, UPC 22755100000. Recall # F-0836-2012;
 
8) Giant Eagle Mini New York Sandwich Ring, UPC 25755500000. Recall # F-0837-2012;
 
9) Giant Eagle Large All American Sandwich Ring, UPC 21755100000. Recall # F-0838-2012;
 
10) Giant Eagle Mini All American Sandwich Ring, UPC 26755500000. Recall # F-0839-2012
CODE
1), 2), 3) and 4) Best by 14OCT2011 10:06 A106A and A106B;
5) thru 10) Product purchased between Oct 5 and 12, 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Giant Eagle, Pittsburgh, PA, by telephone and press release on October 12, 2011.
Manufacturer: River Ranch Fresh Foods LLC, Salinas, CA. Ohio Initiated recall is ongoing.
REASON
The product was manufactured using the Farmers Market shredded iceburg lettuce found to be contaminated with Listeria monocytogenes by the Ohio Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
4,431 units
DISTRIBUTION
PA, OH
___________________________________
PRODUCT
Sliced Herring Fillet (Forelka) 330 gram and 600 gram 21.1 oz. plastic container. Recall # F-0847-2012
CODE
Best by Date 5/18/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zip International Group LLC, Edison, NJ, by letters on January 31, 2012 and a press release dated February 9, 2012.
Manufacturer: Pleyady LTD., Boyarka, Ukraine. New York initiated recall is ongoing.
REASON
Listeria contamination in herring.
VOLUME OF PRODUCT IN COMMERCE
330g 15 cases (12 containers each); 600 gram 15 cases (12 containers each)
DISTRIBUTION
NY
___________________________________
PRODUCT
FUMA CUSTARD PIE, 650 gram cardboard box containing 26 individually wrapped packages, UPC 6 921682 819305, Product of China. --- Product labeling is mainly in Chinese. Recall # F-0848-2012
CODE
Date code of 2010 02 04AA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega Ny International Co., Ltd., Brooklyn, NY, by press release on June 10, 2010 and June 30, 2010.
Manufacturer: Quanzhou Goldenfuture Food Group CO., LTD, Huian, China. New York initiated recall is complete.
REASON
The product contained undeclared eggs based on sampling and analysis by New York State Department of Agriculture & Markets. The formulation provided by the manufacturer revealed that the product also contained milk powder which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
109 cases (8 x 650 gm boxes per case)
DISTRIBUTION
NY City area (Brooklyn, Queens, and Manhattan)
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
The Bakery at WalMart 12 count Glazed donuts. 27 oz (1 lb 11 oz). Item Number 9853243. UPC: 0007874299175. Recall # F-0828-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wal Mart Stores, Inc., Bentonville, AR, by e-mail on February 21, 2012.
Manufacturers: Roskam Baking Co., Grand Rapids, MI;
Wal Mart Stores, Inc., Bentonville, AR. Firm initiated recall is ongoing.
REASON
Product does not list the common name of milk following whey, a milk derivative, on the ingredient label.
VOLUME OF PRODUCT IN COMMERCE
546 units
DISTRIBUTION
AZ, TX
___________________________________
PRODUCT
ShurFine A Change for the Butter, 58% vegetable oil spread, packaged in 16-oz. plastic tubs, UPC #015400835107. Recall # F-0829-2012
CODE
Lot #12011SS9
RECALLING FIRM/MANUFACTURER
CFS West Holdings Inc., New Century, KS, by telephone on February 16, 2012. Firm initiated recall is ongoing.
REASON
Some of the product containers have the incorrect lids which do not declare milk.
VOLUME OF PRODUCT IN COMMERCE
3,708/16-oz. tubs (206 cases)
DISTRIBUTION
TX
___________________________________
PRODUCT
Corn tortillas packaged in clear plastic in two different sizes, 3 dozen tortillas (Net Wt. 36 oz) UPC 821658114068; and 7 dozen tortillas (84 oz.) UPC 821658116246. The front label reads in part: KEEP REFRIGERATED AFTER PURCHASE***Sergio's Tortillas***CORN TORTILLAS***". The back label reads in part: "***INGREDIENTS: ***Corn Cooked with Lime-Water, ***". Recall # F-0840-2012
CODE
None
RECALLING FIRM/MANUFACTURER
De Leon Foods, Inc., Spokane, WA, by visit on February 1, 2012 and by letter on February 2, 2012. FDA initiated recall is complete.
REASON
Corn tortillas contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
3 dozen size: 253 packages. 7 dozen size: 117 packages. Total of 370 packages
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Spice King Duck Sauce in single serve plastic packet, packaged 500/packets in cardboard shipping case. The case weighs 15 lb/full, UPC code 11435 15005. Recall # F-0841-2012;
 
2) Spice King Mustard Sauce in single serve plastic packet, packaged 500/packets in cardboard shipping case. The case weighs 15 lb/full, UPC code 11435 15003.Recall # F-0842-2012;
 
3) Spice King Sweet & Sour Sauce in single serve plastic packet, packaged 500/packets in cardboard shipping case. The case weighs 15 lb/full, UPC code 11435 15002. Recall # F-0843-2012;
 
4) Spice King Hot Sauce in single serve plastic packet, packaged 500/packets in cardboard shipping case. The case weighs 15 lb/full, UPC code 11435 15004. Recall # F-0844-2012;
 
5) Spice King Soy Sauce in single serve plastic packet, packaged 500/packets in cardboard shipping case. The case weighs 15 lb/full, UPC code 11435 15001. Recall # F-0845-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Baily International Inc. dba Spice King, Saint Louis, MO, by telephone on April 25, 2011 and letter on April 26, 2011 and April 27, 2011. Missouri initiated recall is ongoing.
REASON
Acetic acid labeled as industrial use only was used as an ingredient in the sauce production (in lieu of food grade vinegar).
VOLUME OF PRODUCT IN COMMERCE
Unknown exact amount, firm assumes 59,613/15lb cases of all 5 sauces in 2010 and 2011.
DISTRIBUTION
LA, MO, CA
___________________________________
PRODUCT
Western Family, Denali Extreme Moose Tracts, Rich Chocolate Ice Cream with Moose Tracks Fudge Filled Cups and Famous Moose Tracks Fudge 1.50 Quarts, INGREDIENTS: Milk, Cream, Skim Milk,***Fudge Cups***Sugar, Peanut Oil,***CONTAINS: Milk, Peanut, Soy. Recall # F-0846-2012
CODE
Best by 11/30/2012
RECALLING FIRM/MANUFACTURER
Dean Foods, Inc. dba Meadow Gold Dairies, Orem, UT, by telephone on February 16, 2012. Firm initiated recall is ongoing.
REASON
The product does not list peanut butter cups as an ingredient; however, peanut oil is listed and peanut is stated in the "Contains" statement. Peanut butter cups were added unintentionally.
VOLUME OF PRODUCT IN COMMERCE
6,336 - 1.5 quart containers
DISTRIBUTION
UT, MT
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
____________________________________________
PRODUCT
Argatroban Injection 50 mg per 50ml (1 mg per ml) Rx Only, 1) Single Use Vial, NDC 42367-203-07; 2) 10 Single Use Vials, NDC 42367-203-84
CODE
Lot #V10189 Exp. date 01/2013 Lot #V10191 Exp. date 01/2013 Lot #V10194 Exp. date 01/2013 Lot #V10223 Exp. date 02/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eagle Pharmaceuticals Inc, Woodcliff Lake, NJ
Manufacturer: Cipla Ltd. Goa, India
REASON FOR RECALL
Presence of Particulate Matter: crystalline particulates found.
­­­­­­­­­­­­_______________________________________________
PRODUCT
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, 28-count tablets per blister card, packaged in 3 blister cards per carton
CODE
Lot #: 04110101, 04110106, 04110107, Exp 07/31/13; 04110114, 04110124, 04110129, Exp 08/31/2013; and 04110134, Exp 09/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Generics Inc., USA, Mahwah, NJ
Manufacturer: Glenmark Generics Limited, Colvale Bardez, India
REASON FOR RECALL
Contraceptive Tablets Out of Sequence: Due to a packaging error, select blisters of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. 
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx only, NDC 0409-7972-08. Recall # D-1257-2012
CODE
Lot Code: 09-060-JT
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Austin, TX, by letters on February 13, 2012. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: there is a potential for solution to leak from the administration port of the primary container.
VOLUME OF PRODUCT IN COMMERCE
18,356 Bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fludeoxyglucose F18 Injection, multiple-dose glass vial containing 0.74 - 11.1 GBq (20 - 300 mCi/mL), and labeled in part ***Sterile Non-pyrogenic***Radioactive. Recall # D-1258-2012
CODE
Lot 6509, Exp 6:15 pm on 27 Dec 2011
RECALLING FIRM/MANUFACTURER
Precision Nuclear of Virginia, Salem, VA, by telephone on December 27, 2011 and by letter on December 29, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Product contains residual by-products of the manufacturing process which were above allowances.
VOLUME OF PRODUCT IN COMMERCE
8 doses
DISTRIBUTION
VA
___________________________________
PRODUCT
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch (NDC 54092-554-01), packaged in 30-count patches per box (NDC 54092-554-30), Rx only. Recall # D-1259-2012
CODE
Lot #: 47313, Exp 07/12; 47937, Exp 08/12; 47955, Exp 09/12
RECALLING FIRM/MANUFACTURER
Noven Pharmaceuticals, Inc., Miami FL, by letter dated March 2011. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force and/or the z-statistic.
VOLUME OF PRODUCT IN COMMERCE
18,695 patches
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only. Recall # D-1260-2012
CODE
Lot # 50890, 50894, Exp 12/12
RECALLING FIRM/MANUFACTURER
Noven Pharmaceuticals, Inc., Miami, FL, by letter dated September 2011. Firm initiated is ongoing.
REASON
Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force and/or the z-statistic.
VOLUME OF PRODUCT IN COMMERCE
235,440 patches
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Gentamicin Sulfate in 0.9% Sodium Chloride Injection, 80 mg in 50 mL single dose VIAFLEX Plus Container, NDC 0338-0509-41. Recall # D-1256-2012
CODE
Lot #: P266742, Exp. 10/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 17, 2012, 
Manufacturer: Baxter Healthcare Corp., Jayuya, PR. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: An analytical calculation error resulted in the release of a lot of finished product Isotonic Gentamicin Sulfate Injection that was 2% below the approved concentration range.
VOLUME OF PRODUCT IN COMMERCE
94,896 Viaflex Plus Containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cervidil (Dinoprostone) 10 mg Vaginal Insert; supplied in boxes of 6, Rx only, NDC 0456-4123-63, Item #194-2242. Recall # D-1261-2012
CODE
Lot numbers: MA09D05B, MA09H04B, MA09W02B, MA09N06B, MA09K01B, MA09K07B, MA09F08B, MA09F10B, MA09P05B, MA09R01B, MA09R07B, MA10D02B, MA10D03B, MA10W07B, MA10N05B, MA10N07B, MA10Q07B, MA10Q09B, MA10K07B, MA10K06B, MA10X06B, MA10F05B, MA10F06B, MA10R03B, MA10R04B, MA10B07B, MA11D06B, MA11W04B, MA11N05B, MA11Q02B, MA11Q08B, MA11K05B, MA11X03B, MA11K03B, MA08P02B and MA11W05B.
RECALLING FIRM/MANUFACTURER
Recall Firm: H D Smith Wholesale Drug Co., Springfield, IL, by telephone and e-mails the weekend of January 28-29, 2012, and by letter on February 2, 2012.
Manufacturer: Controlled Therapeutics, Ltd., East Kilbride, UK. Firm initiated recall is ongoing.
REASON
Temperature Abuse; product not stored at labeled temperature.
VOLUME OF PRODUCT IN COMMERCE
760 boxes
DISTRIBUTION
DE, FL, MD, NJ, NY, PA, TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0670-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0671-12
CODE
1) W224311324363; W224311324503; W224311324178; W224311324772; W224311324816; W224311511797; W224311323459; W224311324241; W224311512253; W224311324906; W224311512718; W224311512452; W224311512475; W224311324491;
 
2) W224311324112; W224311323282; W224311704590; W224311512094; W224311323381; W224311324881; W224311324017; W224311324014; W224311323462; W224311323503; W224311512145; W224311324510; W224311324506; W224311322908; W224311323686; W224311323667
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on November 18, 2011 and fax on November 21, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-0693-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0694-12
CODE
1) and 2) Unit: W041611022256P
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone and facsimile on December 7, 2011 and by telephone and facsimile on December 21, 2011. 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
TN, MS
___________________________________
PRODUCT
1) Fresh Frozen Plasma (Apheresis). Recall # B-0700-12;
2) Red Blood Cells (Apheresis). Recall # B-0701-12;
3) Platelets Pheresis. Recall # B-0702-12
CODE
1) Unit: W038510701403;
2) Unit; W038510700436;
3) Units: W038511705263 (Parts A & B), W038510701403, W038510700883 (Parts A & B), W038510700436
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on January 11, 2012. 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
8 units
DISTRIBUTION
SC, GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0703-12
CODE
Unit: W0411111095815
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone and facsimile on December 12, 2011. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
New Mexico
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0705-12
CODE
Unit: W036811076503 (part 1), W036811076503 (part 2)
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Inc., Orlando, FL, by telephone and letter on December 14, 2011. 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
FL
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0706-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0707-12
CODE
1) and 2) Unit: 12FR25259
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on November 30, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, PA, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0709-12
CODE
Unit: W065611049203
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone on January 4, 2012 and follow up letter on January 16, 2012. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0713-12
CODE
Unit: W141607192993
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on May 16, 2007.
Manufacturer: Puget Sound Blood Center, Silverdale, WA. 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
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0714-12
CODE
Unit: 7239028 (2 units)
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile on March 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0715-12
CODE
Unit: 7239196
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated June 5, 2007. 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
OR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0718-12
CODE
Unit: 21LK19046
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by letter dated June 13, 2006. 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
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0719-12
CODE
Unit: 21LY20361
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on June 7, 2006 and by letter dated June 21, 2006. 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
OR
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0721-12
CODE
Unit: J14100
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on June 18, 2008 and by letter dated June 24, 2008. 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
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0722-12
CODE
Units: 3690212130, 3690211502, 3690211006
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Pueblo, CO, by facsimile on December 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Cryoprecipitated AHF, Pooled. Recall # B-0723-12;
2) Plasma Cryoprecipitated Reduced. Recall # B-0724-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0725-12
CODE
1) Unit: W036809812879;
2) and 3) Unit: W036809357976
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on April 5, 2011 and by letter dated April 6, 2011. 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
3 units
DISTRIBUTION
IL, FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0726-12;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0727-12;
3) Fresh Frozen Plasma. Recall # B-0728-12
CODE
1) and 3) Unit: W036810269759;
2) Unit: W036810823592
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone on November 22, 2011 and by letter dated November 23, 2011. 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
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0731-12
CODE
Unit: W141608193485
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile on June 9, 2008.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. 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
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0741-12;
2) Fresh Frozen Plasma. Recall # B-0742-12
CODE
1) and 2) Unit: 06GC45674
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on March 6, 2008 and by letter dated March 6, 2008. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0745-12
CODE
Unit: 06LG41219
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter dated February 27, 2008 or by electronic notification on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0746-12;
2) Plasma Frozen. Recall # B-0747-12
CODE
1) and 2) Unit: 06GV52029
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on March 25, 2008 and by letters dated March 26, 2008 and June 5, 2008. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0748-12
CODE
Unit: 06LR27734
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter dated June 22, 2007 or by electronic notification on June 22, 2007. Firm initiated recall is complete.
REASON                       
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0750-12
CODE
Unit: 06GJ95054
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letters dated March 13, 2007 and May 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0754-12
CODE
Unit: 21LM24066
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by letter dated August 17, 2007. 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
OR
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0756-12
CODE
Units: 21KT28062, 21KT28063
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on August 22, 2007 and by letter dated August 22, 2007. Firm initiated recall is complete.
REASON
Blood products, for which sterile docking procedures were performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0757-12
CODE
Units: 0220052923, 0220053045, 0220053384, 0220053539, 0220053810, 0220053956, 0220054478, 0220054761, 0220054974
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., City of Industry, CA, by facsimile on December 15, 2006.
Manufacturer: Biomat USA, Inc., Kennewick, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Spain
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0758-12
CODE
Units: 21W72788, 21W72792
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by telephone on January 11, 2007 and by letter dated January 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled for the presence of red cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, OR
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0759-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0760-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0761-12;
4) Fresh Frozen Plasma (Apheresis). Recall # B-0762-12;
5) Platelets Pheresis Leukocytes Reduced. Recall # B-0763-12;
6) Platelets, Pheresis Leukocytes Reduced Irradiated. Recall # B-0764-12
CODE
1) Units: 202991893, 301335354, 301336528, 301336543, 301336830, 301336833, 301336848, 301336851, 301336853, 301336864, 301336912, 301336919, 301336934, 301336937, 301336943, 301336948, 301336950, 302991824, 302991836, 302991840, 302991872, 302991874, 302991884, 302991889, 302991896, 302991901, 302991912, 302992058, 302992069, 302992073, 302992075, 302992077, 302992079, 302992082, 302992085, 302992088, 302992090, 302992115, 302992118, 302992122, 302992129, 302992131, 302992133, 302992137, 308444941, 309603576;
 
2) Units: 301335338 (2 units), 301336817 (2 units), 301336827 (2 units), 301336836 (2 units), 301336857 (2 units), 301336901, 301336910 (2 units), 302991867 (2 units), 302991880 (2 units), 302991898 (2 units), 302991905 (2 units), 302991908 (2 units);
 
3) Units: 301336826 (2 units), 302992056, 301336534;
 
4) Units: 301336546 (3 units);
 
5) Units: 301335331, 301335346, 301336546, 301335324;
 
6) Unit: 301335346
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on March 21, 2007 and by letter dated May 14, 2007.
Manufacturer: Blood Systems, Inc., Fargo, ND. 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
81 units
DISTRIBUTION
ND, SD, MN, CA, NJ, TX, AR
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0790-12;
2) Fresh Frozen Plasma. Recall # B-0791-12
CODE
1) and 2) Unit: W12620912801
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on January 11, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0792-12
CODE
Unit: W041111107109B
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone and facsimile on December 16, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0793-12
CODE
Unit: W035411056664
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on December 24, 2011. 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
OH
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall #B-0350-12
CODE
Unit: 36E31437
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbia, SC, by electronic mail on December 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Recovered Plasma.  Recall # B-0695-12
CODE
Unit: 40GZ12522
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Heart of America Region, Peoria, IL, by facsimile on November 30, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0696-12
CODE
Units: W040811400241, W040811203631, W040811116914, W040811116025, W040811121317
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc., Jackson, TN, by telephone on December 13, 2011 and by letter dated December 15, 2011. Firm initiated recall is complete.
REASON
Blood products, which contained red cell antibodies, but were labeled as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0697-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0698-12
CODE
1) and 2) Unit: W120611092003
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by facsimile on December 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0699-12
CODE
Unit: W039511445210
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA, by telephone and facsimile on December 19, 2011. Firm initiated recall is complete.
REASON
Blood product, which contained anti-D antibodies, but was labeled as negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0704-12
CODE
Unit: W120611208187
RECALLING FIRM/MANUFACTURER
Michigan Blood, Traverse City, MI, by facsimile on December 1, 2011. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0708-12
CODE
Unit: 12FR25259
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on November 30, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS, PA, CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0716-12;
2) Cryoprecipitated AHF. Recall # B-0717-12
CODE
1) and 2) Unit: 21LG32587
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on May 27, 2006 and by letter dated June 9, 2006 or June 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a dental graft within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0720-12
CODE
Units: 4992503, 0193021, 5313430, 7743335
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on August 7, 2006. Firm initiated recall is complete.
REASON                       
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0729-12
CODE
Unit: W141608614001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on July 31, 2008.
Manufacturer: Puget Sound Blood Center and Program, Renton, WA. Firm initiated recall is complete.
REASON
Blood product, which may have been stored at an unacceptable temperature, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0744-12
CODE
Unit: 06LG41219
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter dated February 27, 2008 or by electronic notification on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0749-12
CODE
Unit: 06LR27734
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter dated June 22, 2007 or by electronic notification on June 22, 2007. Firm initiated recall is complete.
REASON                       
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0751-12
CODE
Unit: 06GJ95054
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letters dated March 13, 2007 and May 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0765-12
CODE
Unit: 7067156
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on May 11, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON                       
Blood product, for which the bacterial detection testing was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
B. Braun Infusomat Space Pump - US Version Infusion pump, Model # 8713050U. Recall # Z-1015-2012
CODE
Serial #'s 108288 108290 108291 108292 108293 108294 108296 108297 108298 108299 108300 108302 108303 108304 108305 108306 108307 108309 108310 108311 108312 108313 108315 108318 108319 108321 108322 108323 108324 108326 108327 108331 108332 108334 108335 108337 108338 108339 108342 108343 108344 108347 108348 108349 108350 108351 108352 108353 108354 108359 108360 108362 108363 108364 108365 108366 108367 108368 108377 108378 108380 108381 108383 108385 108388 108389 108390 108395 108399 108400 108401 108402 108403 108405 108406 108407 108408 108409 108412 108418 108420 108422 108423 108424 108427 108428 108429 108430 108439 108442 108443 108445 108448 108450 108451 108453 108454 108455 108456 108457 108465 108469 108470 108471 108473 108474 108477 108478 108486 108490 108493 108495 108497 108500 108501 108508 108510 108511 108513 108517 108520 108536 108537 108538 108541 108542 108548 108549 108550 108552 108553 108556 108557 108560 108561 108563 108569 108570 108572 108577 108578 108580 108581 108582 108584 108585 108586 108588 108589 108592 108596 108602 108604 108606 108607 108608 108609 108610 108611 108612 108614 108615 108617 108618 108619 108620 108622 108623 108625 108626 108628 108631 108633 108634 108635 108638 108640 108641 108642 108643 108645 108647 108648 108650 108651 108653 108655 108656 108659 108660 108661 108662 108663 108664 108665 108666 108667 108668 108669 108670 108671 108672 108673 108674 108676 108678 108680 108682 108683 108685 108687 108688 108689 108693 108696 108697 108700 108701 108702 108703 108706 108707 108708 108709 108711 108712 108714 108715 108720 108721 108724 108726 108727 108728 108729 108731 108732 108733 108734 108735 108737 108739 108740 108743 108744 108746 108747 108748 108750 108751 108752 108753 108754 108755 108756 108758 108759 108761 108762 108769 108770 108771 108772 108773 108774 108775 108776 108777 108778 108779 108780 108781 108783 108784 108785 108786 108788 108789 108790 108791 108793 108794 108795 108796 108797 108798 108799 108800 108801 108802 108803 108804 108805 108806 108808 108809 108810 108811 108812 108813 108814 108815 108816 108817 108818 108819 108820 108821 108822 108823 108824 108825 108826 108827 108828 108829 108830 108831 108832 108833 108834 108835 108836 108837 108838 108840 108842 108844 108846 108847 108848 108849 108850 108851 108852 108853 108854 108855 108856 108857 108859 108860 108862 108863 108864 108865 108866 108867 108868 108869 108870 108871 108874 108879 108883 108885 108886 108887 108888 108889 108890 108891 108897 108899 108902 108906 108907 108908 108912 108914 108915 108916 108917 108918 108919 108920 108921 108922 108923 108924 108925 108926 108927 108928 108930 108934 108936 108937 108941 108942 108943 108945 108948 108949 108950 108951 108952 108954 108956 108957 108958 108961 108963 108967 108968 108971 108972 108973 108974 108975 108976 108977 108978 108979 108980 108981 108982 108984 108985 108986 108987 108988 108989 108990 108991 108992 108993 108994 108995 108996 108997 108998 108999 109000 109001 109002 109003 109004 109005 109006 109009 109010 109011 109013 109014 109015 109016 109017 109018 109019 109020 109022 109023 109024 109025 109026 109027 109028 109029 109030 109031 109032 109033 109034 109035 109036 109037 109038 109039 109040 109042 109043 109044 109045 109047 109048 109049 109050 109051 109052 109053 109054 109055 109056 109057 109059 109060 109061 109062 109063 109064 109065 109066 109067 109069 109070 109071 109073 109074 109075 109076 109077 109078 109079 109080 109081 109082 109084 109085 109086 109087 109088 109089 109090 109091 109092 109093 109094 109095 109096 109097 109098 109099 109100 109101 109102 109103 109104 109105 109106 109107 109108 109109 109110 109111 109112 109113 109114 109115 109117 109118 109119 109120 109121 109122 109123 109124 109125 109126 109127 109128 109129 109130 109131 109132 109133 109134 109136 109137 109138 109139 109140 109141 109142 109143 109144 109145 109146 109148 109149 109151 109152 109153 109154 109156 109157 109158 109159 109160 109161 109162 109164 109165 109166 109167 109168 109170 109171 109173 109175 109176 109178 109180 109181 109182 109183 109184 109185 109187 132785 132795 132808 132809 132835 132839 132892 132893 132922 132987 133004 133005 133006 133018 133020 133026 133029 133030 133035 133037 133039 133043 133055 133058 133064 133065 133067 133068 133077 133092 133095 133096 133099 133100 133101 133104 133106 133124 133127 133129 133130 133131 133132 133133 133134 133135 133136 133155 133156 133158 147597 147683 147818 35198 35201 35202 35205 35209 35211 35212 35216 35217 35218 35219 35220 35221 35222 35223 35224 35226 35229 35231 35232 35235 35236 35237 35238 35240 35241 35242 35243 35244 35246 35247 35248 35249 35250 35251 35252 35254 35255 35256 35257 35259 35261 35263 35265 35267 35270 35271 35272 35279 35284 35285 35287 35288 35300 39868 39870 39875 39881 39884 39890 39903 39912 39914 39922 39923 39933 39942 39959 39965 39974 39978 39980 39989 39994 39997 40007 40008 40010 40011 40012 40013 40014 40018 40025 40038 40039 40043 40044 40045 40047 40889 40895 40909 40912 40927 40928 40929 40938 40947 40951 40952 40954 40955 40959 40961 40972 40977 40999 41000 41003 41017 41032 41035 41045 41053 41071 41082 41099 41105 41109 41117 41130 41132 41133 41135 41144 41148 41153 41168 41174 41185 41191 41209 41213 41224 41227 41229 41237 41249 41261 41266 41272 41273 41275 41277 41279 41297 41305 41325 41326 41328 41329 41330 41343 41364 41367 41369 41370 41371 41373 41381 41389 41393 41399 41412 41415 41421 41435 41437 41449 41450 41459 41484 41515 41517 41520 41530 41565 41598 41629 41641 47711 47722 47735 47736 47742 47753 47766 47779 47784 47789 47800 47801 47804 47806 47808 47809 47810 47811 47813 47815 47827 47835 47836 47837 47843 47845 47846 47847 47855 47874 47878 47880 47889 47892 47900 47932 47948 47954 47955 47970 47973 47988 47994 48003 48004 48005 48668 48669 48672 48673 48674 48676 48677 48678 48679 48680 48681 48682 48683 48684 48685 48686 48687 48688 48690 48691 48692 48693 48694 48695 48697 48699 48703 48704 48705 48706 48707 48708 48709 48711 48712 48713 48715 48716 48717 48718 48719 48720 48721 48722 48723 48724 48725 48727 48728 48729 48730 48731 48732 48734 48735 48736 48737 48739 48740 48741 48743 48744 48745 48746 51253 51254 51255 51256 51257 51259 51260 51262 51264 51265 51267 51268 51271 51272 51273 51274 51276 51278 51279 51280 51281 51283 51284 51285 51288 51289 51290 51291 51292 51293 51294 51295 51296 51297 51298 51299 51300 51301 51302 51303 51305 51308 51309 51310 51312 51313 51314 51315 51316 51317 51318 51320 51321 51322 51323 51325 51327 51328 51329 51330 51331 51333 51335 51336 51337 51338 51339 51340 51341 51342 51343 51344 51349 51350 51351 51352 51353 51354 51355 51356 51357 51360 51361 51363 51364 51365 51366 51367 51368 51369 51370 51371 51372 51628 51629 51630 51631 51632 51638 51639 51640 51641 51642 51643 51645 51646 51648 51649 51650 51651 51652 51654 51656 51657 51658 51659 51660 51661 51662 51663 51664 51665 51666 51667 51672 51678 51679 51681 51682 51683 51685 51686 51687 51688 51690 51691 51692 51693 51694 51695 51696 51697 51698 51699 51700 51701 51702 51704 51705 51707 51708 51709 51710 51711 51714 51715 51716 51717 51718 51719 51720 51721 51722 51723 51724 51725 51727 51728 51729 51730 51732 51733 51734 51735 51736 51737 51739 51740 51741 57955 60611 60757 62155 62184 62185 86327 86726 86803 87090 87093 87104 106327 106942 107360 107399 107446 107553 107651 107768 144569 144570 144590 144616 144648 144655 148611 148675 148883 148894 148914 148918 148960 148962 148978 148980 148989 149020 149021 149024 149027 149028 149033 149034 149054 149061 35204 35207 35225 35233 35234 35253 35258 35273 39205 39232 39356 39360 39395 39404 39455 39475 39548 39949 39950 40005 41666 41679 41685 41692 41714 41745 41746 41767 41772 41773 41789 41805 41811 41821 41835 41839 41873 41876 41890 41891 41928 41934 41938 41944 41947 41948 41964 41969 41970 41976 41981 41985 41993 42000 42003 42036 42037 48671 48675 48696 48726 51263 51266 51304 51306 51307 51311 51347 51359 51362 51623 51624 51625 51626 51627 51634 51635 51636 51647 51669 51674 51675 51676 51677 51680 51712 51743 51746 51749 51750 51752 51753 51754 51755 51757 51758 51759 51760 51761 51762 51764 51766 51767 51768 51771 51772 52223 52227 52229 52232 52233 52235 52236 52237 52244 52246 52248 52250 52252 52254 52255 52257 52258 52260 52261 52265 52267 52268 52269 52270 52274 52278 52279 52280 52281 52282 52284 52286 52287 52288 52289 52290 52291 52293 52294 52295 52296 52297 52298 52300 52301 52311 52312 52313 52314 52315 52316 52317 52319 52321 52323 52328 52329 52333 52334 52335 52336 52337 52338 52342 52346 52347 52348 52349 52352 52353 52355 52359 52360 52361 52363 52364 52366 52372 52856 52874 52941 53081 53089 53113 53186 53259 53399 53415 53416 53427 53430 53434 53439 53445 53468 53475 53482 53489 53498 53535 53563 53594 53604 53607 53612 53613 53620 53627 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RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on August 16, 2011.
Manufacturer: B. Braun Melsungen AG, Melsungen, Germany. Firm initiated recall is ongoing.
REASON
Potential for breakage of anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. When the pump and IV set are operated in accordance with the Instructions for Use, any potential for free flow is fully mitigated.
VOLUME OF PRODUCT IN COMMERCE
5769 units
DISTRIBUTION
CA, MO
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
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PRODUCT
1) CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog Number: 500AV - CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Recall # Z-0672-2012;
 
2) CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog Number: 500AVHCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Recall # Z-0673-2012;
 
3) CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02, P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog Number: 500AHCT CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe. Recall # Z-0674-2012;
 
4) CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Catalog Number: 500A CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Recall # Z-0675-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated December 6, 2011. Firm initiated recall is ongoing.
REASON                       
In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented: Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all CDl 500 systems, starting with serial number 2727. The shield protected the power cables from contact with a sharp edge on the metal chassis on the monitor's interior, a situation Which could potentially cause damage to the cable. NOTE: The protective shield was added to prevent possible damage to the cable.
VOLUME OF PRODUCT IN COMMERCE
451 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
1) STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0682-2012;
 
2) STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length, Catalog/REF No. P-S2-12, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0683-2012;
 
3) STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12 length, Catalog/REF No. P-S2-12 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0684-2012;
 
4) STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0685-2012;
 
5) STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0686-2012;
 
6) STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 60 Drops/cc, 84" length, Catalog/REF No. P-S2V-60, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0687-2012;
 
7) STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 60 Drops/cc, 84 length, Catalog/REF No. P-S2V-60 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path. Recall # Z-0688-2012
CODE
1) Beginning Lot Code 0603241, Ending Lot Code 1009105;
2) Beginning Lot Code 0603241, Ending Lot Code 1101064;
3) Beginning Lot Code 0603241, Ending Lot Code 1103114;
4) Beginning Lot Code 0603241, Ending Lot Code 1103114;
5) Beginning Lot Code 0603241, Ending Lot Code 1010144;
6) Beginning Lot Code 0603241, Ending Lot Code 0811031;
7) Beginning Lot Code 0603241, Ending Lot Code 1006094
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp., Utica, NY, by letters dated April 15, 2011.
Manufacturer: ConMed Corp., Utica, NY;
Consolidated Medical Equipment Co., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON                       
ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,146,741 sets
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326,. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0693-2012
CODE
Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021
RECALLING FIRM /MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter dated November 15, 2011. Firm initiated recall is on going.
REASON      
Component defect. When the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
LA, NY, OH, WV, Australia, Germany, Korea, India, Malaysia and New Zealand
___________________________________
PRODUCT
1) Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. Recall # Z-0706-2012;
 
2) Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. Recall # Z-0707-2012;
 
3) Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code: 80-1190 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. Recall # Z-0708-2012;
 
4) Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. Recall # Z-0709-2012;
 
5) Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric Product Code: 80-1197 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. Recall # Z-0710-2012
CODE
1) Lot codes: 10LD1378, 10LD3627;
 
2) Lot codes: 091D1357 09AD4024 09DD3119 09FD2303 09GD1485 09HD0439 09JD0410 09JD3907 09KD2828 09LD2187 10AD2613 l0BD2115 10CD3938 10FD0538 10GD0534 10ID1319 10lD5075 10JD2337 l0JD3344 10JD4027 l0KD0816 10LD1062 10LD3169 11BD0122 11BD3275 11FD0392 l1FD0648 11GD3385 11HD1641;
 
3) Lot codes: 422002 450730 456778 AB243 AC319 BA201 BA202 CB317 DB319 FB302 GA230 HA291 JZ285 KA291 LB213 LZ288;
 
4) Lot codes: 449269 459957 BY254 FA247 KA209 LB283;
5) Lot codes: 114474 456961 BA227 LA216
RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc., Raynham, MA, by letter dated October 25, 2011. Firm initiated recall is ongoing.
REASON                       
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
VOLUME OF PRODUCT IN COMMERCE
18,249 units
DISTRIBUTION
Nationwide, Dubai, Mexico, Panama, Spain and Uruguay
___________________________________
PRODUCT
Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology departments’ clinical and business information. Recall # Z-0713-2012
CODE
Units: HIT0001 HIT0120 HIT0214 HIT0317 HIT0422 HIT0516 HIT0622 HIT0737 HIT0838 HIT0933 HIT1030 HIT1131 HIT0002 HIT0121 HIT0215 HIT0318M HIT0424 HIT0517 HIT0624 HIT0738M HIT0839M HIT0937 HIT1035 HIT1132M HIT0003 HIT0122 HIT0217 HIT0319M HIT0426 HIT0519 HIT0625 HIT0739M HIT0840 HIT0938 HIT1036 HIT1134 HIT0004M HIT0123M HIT0219 HIT0323 HIT0427 HIT0520M HIT0627 HIT0740 HIT0842 HIT0940 HIT1039 HIT1135 HIT0005 HIT0124 HIT0223 HIT0326 HIT0428 HIT0522 HIT0629M HIT0742M HIT0843 HIT0942 HIT1041 HIT1137 HIT0011 HIT0125 HIT0225 HIT0328M HIT0429M HIT0523 HIT0630 HIT0746 HIT0844 HIT0944 HIT1043 HIT1139 HIT0013 HIT0126 HIT0227 HIT0329 HIT0430 HIT0525M HIT0631 HIT0748 HIT0846 HIT0946 HIT1044 HIT1141 HIT0021 HIT0127 HIT0229 HIT0331 HIT0432M HIT0527 HIT0632M HIT0749 HIT0848 HIT0948A1 HIT1046 HIT1142M HIT0023 HIT0130 HIT0231 HIT0333 HIT0434M HIT0528 HIT0633 HIT0750 HIT0849 HIT0948M HIT1047 HIT1144 HIT0025 HIT0132 HIT0234 HIT0335 HIT0436M HIT0531 HIT0637 HIT0754 HIT0850 HIT0949M HIT1049 HIT1145M HIT0027 HIT0134 HIT0236 HIT0337M HIT0437 HIT0532 HIT0639 HIT0756M HIT0851 HIT0950 HIT1050 HIT1149M HIT0028 HIT0137 HIT0238 HIT0339M HIT0441 HIT0533 HIT0641M HIT0757 HIT0852 HIT0951M HIT1052 HIT1151 HIT0029 HIT0138 HIT0241 HIT0341M HIT0442 HIT0535 HIT0642 HIT0759 HIT0854 HIT0952 HIT1053 HIT1152 HIT0030 HIT0139M HIT0242 HIT0342 HIT0443 HIT0537 HIT0643 HIT0760 HIT0856 HIT0954 HIT1054 HIT1155 HIT0031M HIT0140 HIT0244 HIT0344 HIT0444 HIT0539 HIT0645 HIT0762 HIT0857 HIT0956 HIT1056M HIT1157 HIT0032 HIT0143M HIT0246 HIT0347 HIT0446 HIT0540 HIT0647 HIT0764 HIT0858 HIT0958 HIT1058 HIT1159 HIT0038 HIT0144 HIT0247 HIT0348 HIT0448 HIT0541 HIT0649 HIT0766 HIT0860 HIT0959 HIT1059 HIT1160 HIT0040 HIT0145 HIT0249 HIT0350 HIT0450 HIT0542 HIT0650 HIT0767 HIT0863 HIT0960 HIT1060 HIT1163 HIT0041 HIT0147 HIT0251M HIT0351 HIT0452 HIT0544 HIT0651 HIT0769 HIT0864 HIT0962 HIT1062 HIT1164 HIT0043M HIT0148 HIT0254 HIT0353 HIT0454 HIT0547 HIT0652 HIT0771 HIT0866 HIT0963 HIT1064 HIT1166 HIT0045 HIT0150 HIT0255 HIT0355M HIT0456 HIT0549 HIT0653 HIT0773M HIT0868 HIT0965 HIT1065 HIT1168 HIT0047 HIT0152 HIT0259 HIT0357 HIT0458 HIT0551 HIT0655 HIT0776 HIT0869 HIT0967 HIT1066 HIT1170 HIT0049 HIT0154 HIT0261 HIT0359 HIT0459 HIT0553 HIT0657 HIT0777M HIT0870M HIT0968 HIT1069 HIT1172M HIT0050 HIT0155 HIT0262 HIT0361M HIT0461 HIT0555 HIT0658 HIT0779M HIT0872 HIT0970 HIT1070 HIT1174 HIT0052 HIT0157 HIT0264M HIT0363 HIT0462 HIT0556 HIT0660 HIT0781 HIT0874 HIT0972 HIT1072 HIT1176 HIT0055 HIT0158 HIT0265 HIT0366M HIT0464 HIT0558 HIT0662 HIT0782 HIT0876 HIT0975 HIT1074 HIT1179M HIT0057 HIT0162 HIT0266 HIT0370 HIT0465 HIT0563 HIT0663 HIT0784M HIT0879 HIT0977 HIT1076M HIT1181 HIT0059 HIT0165M HIT0267M HIT0372 HIT0467 HIT0565 HIT0665 HIT0787 HIT0880 HIT0978 HIT1077 HIT1184A1 HIT0061 HIT0167 HIT0268 HIT0373M HIT0468M HIT0566 HIT0667 HIT0789 HIT0881 HIT0979 HIT1080 HIT1184M HIT0065 HIT0170M HIT0269 HIT0374 HIT0470 HIT0568M HIT0668 HIT0790 HIT0884 HIT0981 HIT1082 HIT1186 HIT0066 HIT0171 HIT0270 HIT0376 HIT0474M HIT0570 HIT0671 HIT0792 HIT0885 HIT0982M HIT1084 HIT1188 HIT0068 HIT0174 HIT0274 HIT0378 HIT0475 HIT0572 HIT0673 HIT0793 HIT0886 HIT0983M HIT1085 HIT1189 HIT0070 HIT0177M HIT0279 HIT0380 HIT0477M HIT0573 HIT0681 HIT0795 HIT0887 HIT0986M HIT1087 HIT1190 HIT0072 HIT0178 HIT0280 HIT0381 HIT0479 HIT0579M HIT0682 HIT0797 HIT0889 HIT0988 HIT1089 HIT1200 HIT0074M HIT0179 HIT0282M HIT0383 HIT0480M HIT0581 HIT0683 HIT0799 HIT0892 HIT0989 HIT1090 HIT1202 HIT0076 HIT0181 HIT0284 HIT0385 HIT0481 HIT0583 HIT0685M HIT0801 HIT0894 HIT0991 HIT1091 HIT1203 HIT0077 HIT0182 HIT0286 HIT0388 HIT0483 HIT0585M HIT0687 HIT0803 HIT0896 HIT0993 HIT1092 HIT1206 HIT0079M HIT0183 HIT0288 HIT0390 HIT0485 HIT0587 HIT0689M HIT0804 HIT0898 HIT0994 HIT1093 HIT1207 HIT0082 HIT0185 HIT0290 HIT0393 HIT0486 HIT0588 HIT0691M HIT0805 HIT0900M HIT0996 HIT1095 HIT1208 HIT0084 HIT0187 HIT0292 HIT0394 HIT0487 HIT0589M HIT0693M HIT0807 HIT0901M HIT0998 HIT1098 HIT1211 HIT0088 HIT0190M HIT0293 HIT0396 HIT0488 HIT0590 HIT0696 HIT0808M HIT0905M HIT1000 HIT1102 HIT1212 HIT0090 HIT0191M HIT0295 HIT0397 HIT0489M HIT0592 HIT0697 HIT0809 HIT0907 HIT1001 HIT1103 HIT1213 HIT0092 HIT0193 HIT0297 HIT0399M HIT0490 HIT0593 HIT0699 HIT0812 HIT0909 HIT1002 HIT1106 HIT1215 HIT0095 HIT0195M HIT0300 HIT0401 HIT0492 HIT0594 HIT0701 HIT0813 HIT0910 HIT1004 HIT1107 HIT1216 HIT0097M HIT0196 HIT0301 HIT0402 HIT0494 HIT0598 HIT0703M HIT0814M HIT0911 HIT1006 HIT1110M HIT1220M HIT0100 HIT0198M HIT0303 HIT0404 HIT0495 HIT0599 HIT0705 HIT0816 HIT0912 HIT1007 HIT1111 HIT1225 HIT0101 HIT0199 HIT0304 HIT0405 HIT0498 HIT0600 HIT0711M HIT0818M HIT0913 HIT1010 HIT1112 HIT1227 HIT0103 HIT0200 HIT0305 HIT0406 HIT0499 HIT0602 HIT0712 HIT0820 HIT0916 HIT1013 HIT1113 HIT1229 HIT0105M HIT0202 HIT0306 HIT0407 HIT0501 HIT0604 HIT0714 HIT0823 HIT0918M HIT1014 HIT1115 HIT1231 HIT0107 HIT0203 HIT0307 HIT0408 HIT0503M HIT0606M HIT0716 HIT0825 HIT0920 HIT1015 HIT1116 HIT1234 HIT0109 HIT0204 HIT0308M HIT0409 HIT0505 HIT0608 HIT0718 HIT0827 HIT0922 HIT1016 HIT1117 HIT1235M HIT0111 HIT0205 HIT0310 HIT0411M HIT0507 HIT0610 HIT0721 HIT0828 HIT0924 HIT1018 HIT1119M HIT1236 HIT0112 HIT0206 HIT0311 HIT0413 HIT0509 HIT0613 HIT0723M HIT0829 HIT0925 HIT1020M HIT1120 HIT1241 HIT0114 HIT0207 HIT0312 HIT0414 HIT0510 HIT0614 HIT0726 HIT0830 HIT0926 HIT1022 HIT1121 HIT1243 HIT0115 HIT0210 HIT0313 HIT0416 HIT0511 HIT0615M HIT0728 HIT0832 HIT0928 HIT1024 HIT1122 HIT1245 HIT0116M HIT0211 HIT0314 HIT0417 HIT0512 HIT0616 HIT0729 HIT0833 HIT0929 HIT1025 HIT1124 HIT1247 HIT0117 HIT0212 HIT0315 HIT0419 HIT0513 HIT0617 HIT0733 HIT0835 HIT0930 HIT1027 HIT1128 HIT1250 HIT0118 HIT0213 HIT0316 HIT0420 HIT0515 HIT0620 HIT0736 HIT0837 HIT0932M HIT1029 HIT1129 HIT1252M HIT1260 HIT1385M HIT1490 HIT1599 HIT1704 HIT1810 HIT1914 HIT2012 HIT2118 HIT2238 HIT2367 HIT2501 HIT1264 HIT1386 HIT1492 HIT1600M HIT1707 HIT1811 HIT1916 HIT2013 HIT2119 HIT2241 HIT2369 HIT2502 HIT1267 HIT1389 HIT1493 HIT1601 HIT1709 HIT1813 HIT1918 HIT2014 HIT2123 HIT2245 HIT2370 HIT2504 HIT1269 HIT1390 HIT1494 HIT1602M HIT1711 HIT1817 HIT1921 HIT2016 HIT2124 HIT2247M HIT2374 HIT2505 HIT1271 HIT1392 HIT1496 HIT1604 HIT1712 HIT1820 HIT1922 HIT2017 HIT2126 HIT2252 HIT2376 HIT2506 HIT1273 HIT1394 HIT1497M HIT1606 HIT1714 HIT1822 HIT1924M HIT2018 HIT2129M HIT2256 HIT2378 HIT2508 HIT1275 HIT1396 HIT1498 HIT1608M HIT1716 HIT1824 HIT1925 HIT2020 HIT2131 HIT2263 HIT2380 HIT2509 HIT1277 HIT1397 HIT1499M HIT1609M HIT1718 HIT1825 HIT1926 HIT2021 HIT2132 HIT2265 HIT2382 HIT2510 HIT1278 HIT1398 HIT1500M HIT1610M HIT1719M HIT1827 HIT1928 HIT2022 HIT2135 HIT2267M HIT2383 HIT2512M HIT1281M HIT1399 HIT1505 HIT1611M HIT1720 HIT1829 HIT1930 HIT2023M HIT2136 HIT2269 HIT2385 HIT2513 HIT1284 HIT1400 HIT1506 HIT1612M HIT1723M HIT1830M HIT1932 HIT2025 HIT2138 HIT2271 HIT2388 HIT2516 HIT1288 HIT1401 HIT1507 HIT1613 HIT1724 HIT1831M HIT1934M HIT2027 HIT2140 HIT2272 HIT2390 HIT2519 HIT1290 HIT1402 HIT1509 HIT1614 HIT1725 HIT1833 HIT1938M HIT2028 HIT2145 HIT2273M HIT2392 HIT2521 HIT1293 HIT1404 HIT1510 HIT1616 HIT1726 HIT1837M HIT1941 HIT2029 HIT2146 HIT2275M HIT2394 HIT2522 HIT1294 HIT1406 HIT1511 HIT1617 HIT1729 HIT1838 HIT1942 HIT2031 HIT2149 HIT2277 HIT2397 HIT2523 HIT1296 HIT1408 HIT1512M HIT1619 HIT1731 HIT1839 HIT1943M HIT2034 HIT2151 HIT2278 HIT2399 HIT2526 HIT1298 HIT1410 HIT1514 HIT1620M HIT1733 HIT1840 HIT1944M HIT2036 HIT2152 HIT2279 HIT2400 HIT2528 HIT1300 HIT1412 HIT1516M HIT1622 HIT1735 HIT1842 HIT1945 HIT2037M HIT2154 HIT2282 HIT2402 HIT2529 HIT1301 HIT1413 HIT1517M HIT1623 HIT1736 HIT1843 HIT1947 HIT2039 HIT2156 HIT2283M HIT2404 HIT2531 HIT1303 HIT1414M HIT1518M HIT1624 HIT1738 HIT1845 HIT1948 HIT2041 HIT2158 HIT2285 HIT2405 HIT2533 HIT1306 HIT1415 HIT1520 HIT1625 HIT1741 HIT1848 HIT1951 HIT2042 HIT2159 HIT2287 HIT2409M HIT2534 HIT1308 HIT1418 HIT1521 HIT1626 HIT1742M HIT1850 HIT1952 HIT2044 HIT2160 HIT2289 HIT2411 HIT2535 HIT1310 HIT1419 HIT1522 HIT1628 HIT1744 HIT1852 HIT1953 HIT2045M HIT2162 HIT2291M HIT2414M HIT2537 HIT1311 HIT1420 HIT1523M HIT1629M HIT1745 HIT1854 HIT1955M HIT2047M HIT2164 HIT2293 HIT2417 HIT2539 HIT1313 HIT1421 HIT1526 HIT1632 HIT1747M HIT1855 HIT1956 HIT2049 HIT2166 HIT2296 HIT2420 HIT2541 HIT1315 HIT1423 HIT1529 HIT1633 HIT1748 HIT1857 HIT1958 HIT2051 HIT2168 HIT2298 HIT2421 HIT2543 HIT1317 HIT1426 HIT1531 HIT1635 HIT1750 HIT1859 HIT1961 HIT2053 HIT2171 HIT2299M HIT2422 HIT2544 HIT1318 HIT1428 HIT1536 HIT1639 HIT1751 HIT1860 HIT1963 HIT2056 HIT2172 HIT2301 HIT2424 HIT2546 HIT1321 HIT1429 HIT1537 HIT1642 HIT1753 HIT1861 HIT1964 HIT2058 HIT2173 HIT2303 HIT2425 HIT2554 HIT1323 HIT1430M HIT1539 HIT1644 HIT1757 HIT1863 HIT1965 HIT2063 HIT2178 HIT2305 HIT2429 HIT2555 HIT1325 HIT1432 HIT1541 HIT1649 HIT1758 HIT1864 HIT1967 HIT2064 HIT2180 HIT2314 HIT2430 HIT2557 HIT1327 HIT1433 HIT1544 HIT1651 HIT1760 HIT1865 HIT1968 HIT2065 HIT2182 HIT2316 HIT2431 HIT2559 HIT1329 HIT1434M HIT1546 HIT1653 HIT1761 HIT1866 HIT1969 HIT2067 HIT2183 HIT2317 HIT2432M HIT2561 HIT1331M HIT1435 HIT1548 HIT1655 HIT1763 HIT1867 HIT1970M HIT2068 HIT2185 HIT2318 HIT2434 HIT2563M HIT1332 HIT1436 HIT1549 HIT1658 HIT1764M HIT1870M HIT1973 HIT2069 HIT2187 HIT2319 HIT2435 HIT2564 HIT1336 HIT1438 HIT1551 HIT1660M HIT1765 HIT1871M HIT1975 HIT2074 HIT2188 HIT2320 HIT2437 HIT2565 HIT1338 HIT1440 HIT1553 HIT1662 HIT1767 HIT1874 HIT1976 HIT2076 HIT2190M HIT2321 HIT2439 HIT2567 HIT1339M HIT1443 HIT1554 HIT1665 HIT1768 HIT1875 HIT1977 HIT2078 HIT2191 HIT2323 HIT2441 HIT2568 HIT1342 HIT1444 HIT1556 HIT1667 HIT1770 HIT1876 HIT1978 HIT2079 HIT2193 HIT2325 HIT2443 HIT2570A1 HIT1343 HIT1446 HIT1557 HIT1669 HIT1771 HIT1877 HIT1980M HIT2080 HIT2196 HIT2326 HIT2444 HIT2570M HIT1344M HIT1448M HIT1558 HIT1671 HIT1773 HIT1879 HIT1981 HIT2081 HIT2198 HIT2327 HIT2445 HIT2572 HIT1346M HIT1450 HIT1560M HIT1674 HIT1778 HIT1880 HIT1982 HIT2083 HIT2199 HIT2329 HIT2446 HIT2574A1 HIT1347 HIT1451 HIT1563 HIT1675 HIT1780 HIT1882 HIT1986 HIT2085 HIT2202 HIT2331 HIT2448 HIT2574A2 HIT1348 HIT1452 HIT1565M HIT1677 HIT1781 HIT1885 HIT1987 HIT2087 HIT2204 HIT2333 HIT2449M HIT2574M HIT1350 HIT1454 HIT1567 HIT1678 HIT1782 HIT1887 HIT1988 HIT2088 HIT2205 HIT2335 HIT2451 HIT2576 HIT1353M HIT1456 HIT1571 HIT1679 HIT1787 HIT1888 HIT1989 HIT2089 HIT2208M HIT2336 HIT2453 HIT2577 HIT1354 HIT1458M HIT1573 HIT1680 HIT1788 HIT1889 HIT1991 HIT2091 HIT2209 HIT2337M HIT2455 HIT2584 HIT1356 HIT1460 HIT1574 HIT1681 HIT1790M HIT1890 HIT1994 HIT2093 HIT2212 HIT2341 HIT2461 HIT2588 HIT1359 HIT1462 HIT1575 HIT1683 HIT1794 HIT1893 HIT1996 HIT2095 HIT2215 HIT2342 HIT2463M HIT2589 HIT1360 HIT1464 HIT1577 HIT1684 HIT1795 HIT1894 HIT1997M HIT2098 HIT2218 HIT2343 HIT2464 HIT2591 HIT1361 HIT1466 HIT1579M HIT1686 HIT1797 HIT1895 HIT1998 HIT2100 HIT2219 HIT2345 HIT2467 HIT2593 HIT1363M HIT1467 HIT1580 HIT1687 HIT1798 HIT1896 HIT2000 HIT2101M HIT2221 HIT2346M HIT2469 HIT2596 HIT1365M HIT1469 HIT1581 HIT1688 HIT1799 HIT1898 HIT2002 HIT2102 HIT2222 HIT2348 HIT2471M HIT2598 HIT1369 HIT1470M HIT1582 HIT1690 HIT1800 HIT1899 HIT2003 HIT2105 HIT2223 HIT2350 HIT2473 HIT2600 HIT1371 HIT1473 HIT1584 HIT1691 HIT1801 HIT1900 HIT2004 HIT2107 HIT2225 HIT2353 HIT2475 HIT2602 HIT1373 HIT1475 HIT1585 HIT1693 HIT1802 HIT1901 HIT2005M HIT2109 HIT2226 HIT2355 HIT2477M HIT2603 HIT1375 HIT1478 HIT1587M HIT1696 HIT1803 HIT1903 HIT2006 HIT2110 HIT2228 HIT2357 HIT2480 HIT2605 HIT1376 HIT1481 HIT1589M HIT1697M HIT1804M HIT1904M HIT2007 HIT2111M HIT2229 HIT2358 HIT2482 HIT2606 HIT1379 HIT1483 HIT1591 HIT1698 HIT1805 HIT1905 HIT2008 HIT2112 HIT2231 HIT2359 HIT2484 HIT2609 HIT1380 HIT1486 HIT1592 HIT1700 HIT1806 HIT1907 HIT2009 HIT2113M HIT2233 HIT2361 HIT2491 HIT2612 HIT1381 HIT1488 HIT1594 HIT1701M HIT1808 HIT1911 HIT2010M HIT2115 HIT2236 HIT2362M HIT2493 HIT2615 HIT1383 HIT1489 HIT1597 HIT1703 HIT1809 HIT1913 HIT2011 HIT2117 HIT2237M HIT2364 HIT2498 HIT2620 HIT2621 HIT2741 HIT2891 HIT3018 HIT3140 HIT3274 HIT3404M HIT3527 HIT3671 HIT3796 HIT3936 HIT4112 HIT2622 HIT2742 HIT2892 HIT3019 HIT3145 HIT3277 HIT3406 HIT3529 HIT3675 HIT3798 HIT3939 HIT4114 HIT2623A1 HIT2744 HIT2894M HIT3020 HIT3147 HIT3279 HIT3407 HIT3531 HIT3677 HIT3799 HIT3941 HIT4116 HIT2623M HIT2747 HIT2895 HIT3021 HIT3153 HIT3282 HIT3409 HIT3535 HIT3679 HIT3801 HIT3943 HIT4117 HIT2625 HIT2749 HIT2896 HIT3025 HIT3154 HIT3288 HIT3411 HIT3537 HIT3680 HIT3802 HIT3945 HIT4118M HIT2627 HIT2752 HIT2897 HIT3027 HIT3157M HIT3290 HIT3412 HIT3539 HIT3682 HIT3803 HIT3946 HIT4122 HIT2629 HIT2754 HIT2899 HIT3028 HIT3160 HIT3293 HIT3413 HIT3541 HIT3684 HIT3804 HIT3952 HIT4123 HIT2630 HIT2757 HIT2900 HIT3032 HIT3162 HIT3295 HIT3423 HIT3546 HIT3686 HIT3807 HIT3954 HIT4129 HIT2633 HIT2759 HIT2902 HIT3033 HIT3165 HIT3296 HIT3424 HIT3549 HIT3690 HIT3813 HIT3955 HIT4130 HIT2635 HIT2761 HIT2903 HIT3034 HIT3168 HIT3298M HIT3425 HIT3551 HIT3691 HIT3815 HIT3957 HIT4132 HIT2637 HIT2763 HIT2906 HIT3039 HIT3172 HIT3299M HIT3427 HIT3555 HIT3692 HIT3816 HIT3962 HIT4133 HIT2639 HIT2764 HIT2908M HIT3040 HIT3173 HIT3302 HIT3428 HIT3560 HIT3697 HIT3822 HIT3964 HIT4136 HIT2640M HIT2766 HIT2911 HIT3042 HIT3174 HIT3304 HIT3432 HIT3563M HIT3700 HIT3823 HIT3965 HIT4139 HIT2643 HIT2767 HIT2915 HIT3044 HIT3177 HIT3308 HIT3434 HIT3564 HIT3702 HIT3826 HIT3967 HIT4144 HIT2645 HIT2768 HIT2918M HIT3045 HIT3179 HIT3309 HIT3435 HIT3573 HIT3705 HIT3828 HIT3969 HIT4146 HIT2647 HIT2769 HIT2919 HIT3048 HIT3184 HIT3311 HIT3438 HIT3575 HIT3706 HIT3829 HIT3970 HIT4149 HIT2649M HIT2770 HIT2923 HIT3050 HIT3186 HIT3314 HIT3439 HIT3578 HIT3708 HIT3832 HIT3973 HIT4151 HIT2650 HIT2772 HIT2929 HIT3052 HIT3187 HIT3315 HIT3441 HIT3579 HIT3710 HIT3837 HIT3975 HIT4154 HIT2652 HIT2774 HIT2930 HIT3054 HIT3188 HIT3319 HIT3446 HIT3580 HIT3713 HIT3841 HIT3977 HIT4156 HIT2655 HIT2777 HIT2932 HIT3055 HIT3192M HIT3320 HIT3448 HIT3582 HIT3714 HIT3843 HIT3980 HIT4158 HIT2657 HIT2779 HIT2934 HIT3057 HIT3194 HIT3322 HIT3449M HIT3583 HIT3717 HIT3844 HIT3984 HIT4159 HIT2658 HIT2780 HIT2935 HIT3058 HIT3195 HIT3324 HIT3454 HIT3585 HIT3718 HIT3845 HIT3988 HIT4160M HIT2659 HIT2783 HIT2937 HIT3059 HIT3198 HIT3326 HIT3455 HIT3587 HIT3719 HIT3847 HIT3989 HIT4163M HIT2660 HIT2788 HIT2939 HIT3061 HIT3199 HIT3327 HIT3456 HIT3588 HIT3720 HIT3849 HIT3992 HIT4165 HIT2662 HIT2790 HIT2941 HIT3063 HIT3201 HIT3328 HIT3457 HIT3591 HIT3722 HIT3852 HIT3994 HIT4167 HIT2666 HIT2793 HIT2942 HIT3064 HIT3204 HIT3329 HIT3459 HIT3592 HIT3724 HIT3854 HIT3997 HIT4168 HIT2668 HIT2794 HIT2943 HIT3070 HIT3206 HIT3333 HIT3460 HIT3595 HIT3725 HIT3856 HIT3998 HIT4169 HIT2670 HIT2795 HIT2945 HIT3072 HIT3209 HIT3336 HIT3461 HIT3598M HIT3726 HIT3860 HIT4001 HIT4171 HIT2676 HIT2797 HIT2950 HIT3073 HIT3216 HIT3338 HIT3463 HIT3601 HIT3727 HIT3862 HIT4003 HIT4178 HIT2681 HIT2812 HIT2951 HIT3074 HIT3218 HIT3340 HIT3464 HIT3603 HIT3731 HIT3863 HIT4007 HIT4181 HIT2686 HIT2813 HIT2953 HIT3077 HIT3219 HIT3341 HIT3466M HIT3605 HIT3732 HIT3865 HIT4009 HIT4188 HIT2687 HIT2816 HIT2954 HIT3081 HIT3220 HIT3342 HIT3468 HIT3607 HIT3735 HIT3867 HIT4010 HIT4190 HIT2688 HIT2818 HIT2961 HIT3084 HIT3221M HIT3344 HIT3469 HIT3609 HIT3736 HIT3869 HIT4011 HIT4191 HIT2689 HIT2823 HIT2965 HIT3087 HIT3222 HIT3349 HIT3470M HIT3612 HIT3738 HIT3871 HIT4013 HIT4193 HIT2690 HIT2825 HIT2966 HIT3088M HIT3224 HIT3354 HIT3473 HIT3614 HIT3739M HIT3873 HIT4014 HIT4196 HIT2692 HIT2826 HIT2968 HIT3089 HIT3226 HIT3355 HIT3474 HIT3615 HIT3740 HIT3875 HIT4015 HIT4204 HIT2693 HIT2828 HIT2970 HIT3091 HIT3227 HIT3356 HIT3476 HIT3618 HIT3741M HIT3876 HIT4016 HIT4206M HIT2694 HIT2830 HIT2973 HIT3092 HIT3230 HIT3359 HIT3478 HIT3624 HIT3742 HIT3879 HIT4017 HIT4232 HIT2695 HIT2831 HIT2974 HIT3093 HIT3232 HIT3360 HIT3479 HIT3625 HIT3744 HIT3881 HIT4020 HIT4234 HIT2699 HIT2834 HIT2975 HIT3095 HIT3233 HIT3362M HIT3481 HIT3627 HIT3752 HIT3883 HIT4027 HIT4235 HIT2701M HIT2835 HIT2977 HIT3097 HIT3234 HIT3364 HIT3483 HIT3628 HIT3753 HIT3887 HIT4030 HIT4237 HIT2702 HIT2836 HIT2980 HIT3100 HIT3236 HIT3365 HIT3484 HIT3629 HIT3754 HIT3888 HIT4034 HIT4240 HIT2703 HIT2840 HIT2981 HIT3102 HIT3237 HIT3366 HIT3486 HIT3630 HIT3755 HIT3891M HIT4038 HIT4242 HIT2704 HIT2842 HIT2982 HIT3106 HIT3239 HIT3367 HIT3489 HIT3631 HIT3757 HIT3896 HIT4043 HIT4245 HIT2705 HIT2843 HIT2984 HIT3109 HIT3240 HIT3369 HIT3492 HIT3633 HIT3758M HIT3897 HIT4045 HIT4251 HIT2706 HIT2852 HIT2985 HIT3110 HIT3241 HIT3370 HIT3494 HIT3635 HIT3759 HIT3899 HIT4047 HIT4252 HIT2710M HIT2854M HIT2987 HIT3112M HIT3242 HIT3373 HIT3495 HIT3638 HIT3764M HIT3901 HIT4051 HIT4253 HIT2711 HIT2856M HIT2988 HIT3116M HIT3244 HIT3376 HIT3498 HIT3640 HIT3766 HIT3902 HIT4053 HIT4254 HIT2715 HIT2860 HIT2991 HIT3117 HIT3245 HIT3379 HIT3499 HIT3641 HIT3767 HIT3904 HIT4057 HIT4255 HIT2716 HIT2863 HIT2992 HIT3118 HIT3250 HIT3384 HIT3501 HIT3642 HIT3769 HIT3906 HIT4062M HIT4257 HIT2717 HIT2865 HIT2993 HIT3119 HIT3251 HIT3386 HIT3503 HIT3644 HIT3771 HIT3908 HIT4065 HIT4262 HIT2720 HIT2867 HIT2995 HIT3121 HIT3254 HIT3388 HIT3505 HIT3646 HIT3775 HIT3910 HIT4071 HIT4263 HIT2722 HIT2868 HIT2997 HIT3125 HIT3257 HIT3391 HIT3509 HIT3648 HIT3778 HIT3911 HIT4074M HIT4264 HIT2724 HIT2875 HIT2999 HIT3126 HIT3259 HIT3393M HIT3513 HIT3652 HIT3780 HIT3913 HIT4075 HIT4270 HIT2726 HIT2878 HIT3000 HIT3127 HIT3260 HIT3394 HIT3514 HIT3653 HIT3782 HIT3918 HIT4078 HIT4271 HIT2728 HIT2879 HIT3004 HIT3128 HIT3261 HIT3395 HIT3515 HIT3658 HIT3784 HIT3920 HIT4080 HIT4272 HIT2731 HIT2880 HIT3006 HIT3130 HIT3262 HIT3396 HIT3516 HIT3659 HIT3786 HIT3923 HIT4082 HIT4273 HIT2732 HIT2883 HIT3008 HIT3131M HIT3264 HIT3397 HIT3517 HIT3660 HIT3787 HIT3925 HIT4087 HIT4276 HIT2737 HIT2884 HIT3010 HIT3134 HIT3265 HIT3400 HIT3519 HIT3661 HIT3788 HIT3927M HIT4090 HIT4277 HIT2738 HIT2887 HIT3012 HIT3135 HIT3267 HIT3401 HIT3521M HIT3664 HIT3790 HIT3928 HIT4105 HIT4282 HIT2739 HIT2888 HIT3013 HIT3136 HIT3268 HIT3402 HIT3524 HIT3667 HIT3792 HIT3931 HIT4107 HIT4283 HIT2740 HIT2889 HIT3016 HIT3139 HIT3270 HIT3403 HIT3526 HIT3668 HIT3795 HIT3934 HIT4108 HIT4285 HIT4286 HIT4313 HIT4348 HIT4391 HIT4436 HIT4455 HIT4287 HIT4317 HIT4349 HIT4392 HIT4437 HIT4289 HIT4323 HIT4350 HIT4394 HIT4438 HIT4293 HIT4324M HIT4356 HIT4395 HIT4439M HIT4299 HIT4326 HIT4357 HIT4396 HIT4449 HIT4303 HIT4328 HIT4358 HIT4397 HIT4450 HIT4306 HIT4331 HIT4360 HIT4400 HIT4451 HIT4309 HIT4332 HIT4381 HIT4402 HIT4452 HIT4310 HIT4334 HIT4385 HIT4404 HIT4453 HIT4311 HIT4335 HIT4390 HIT4434 HIT4454
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated December 16, 2011. Firm initiated recall is ongoing.
REASON
The Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation.
VOLUME OF PRODUCT IN COMMERCE
2,235 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302805. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0718-2012;
 
2) Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302802. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0719-2012;
 
3) Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302803. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0720-2012;
 
4) Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0721-2012;
 
5) Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) --- Catalog No. [REF] 10302806. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0722-2012;
 
6) Angiodynamic DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302807. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0723-2012;
 
7) Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302809. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0724-2012;
 
8) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302817. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0725-2012;
 
9) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302818.  Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0726-2012;
 
10) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302819.  Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0727-2012;
 
11) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302820. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0728-2012;
 
12) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302822. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0729-2012;
 
13) Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302824. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0730-2012;
 
14) Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302902. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0731-2012
 
15) Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302903. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0732-2012
 
16) Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909. Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. Recall # Z-0733-2012
CODE
1) FG Lot Numbers: 541559, C37646, C37650, C41145;
2) FG Lot Numbers: 547484, 558855, 559599, C37589;
3) FG Lot Numbers: 537938, 543989, 544560, 545071, 545947, 545955, 547465, 558856, C40502;
4) FG Lot Numbers: 541558, 542262, 542266, 543822, 543823, 556670, 556672, C40503;
5) FG Lot Numbers: 537940;
6) FG Lot Numbers: 541565, 547476, 547521;
7) FG Lot Numbers: 539982, 544562, 545954, 546554, 557710, 558859;
8) FG Lot Numbers: C37756;
9) FG Lot Numbers: 541561, 554930;
10) FG Lot Numbers: C40506;
11) FG Lot Numbers: 540565;
12) FG Lot Numbers: 540563, 541564;
13) FG Lot Numbers: 539772, 547537, 554234;
14) FG Lot Numbers: 540228, 554934, 556919;
15) FG Lot Numbers: 543988, 545031;
16) FG Lot Numbers: 549778, 551753
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated December 30, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
VOLUME OF PRODUCT IN COMMERCE
4,271 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care. Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L. Recall # Z-0738-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linet Americas Inc., Charlotte, NC, by letter dated December 9, 2011.
Manufacturer: Linet Spol Sr.O, Slany, Czech Republic. Firm initiated recall is ongoing.
REASON
The premature failure of the Remote Handset buttons may result in unintended movement of the bed.
VOLUME OF PRODUCT IN COMMERCE
29,252 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
V Series Monitor. The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. 510 K - K102004 P/N. Recall # Z-1102-2012
CODE
Serial Numbers 0998-00-1800-101 EGK16006559 0998-00-1800-101 EGK16006562 0998-00-1800-101 EGK16006590 0998-00-1800-101 EGK16006601 0998-00-1800-101 EGK16006628 0998-00-1800-101 EGK16006633 0998-00-1800-101 EGK17006943 0998-00-1800-101 EGK13004267 0998-00-1800-101 EGK13004271 0998-00-1800-101 EGK13004302 0998-00-1800-101 EGK13004303 0998-00-1800-101 EGK13004307 0998-00-1800-101 EGK14005442 0998-00-1800-101 EGK14005446 0998-00-1800-101 EGK14005447 0998-00-1800-101 EGK14005450 0998-00-1800-101 EGK14005454 0998-00-1800-101 EGK14005455 0998-00-1800-101 EGK14005462 0998-00-1800-101 EGK14005480 0998-00-1800-101 EGK14005485 0998-00-1800-101 EGK14005503 0998-00-1800-101 EGK15006285 0998-00-1800-101 EGK15006288 0998-00-1800-101 EGK15006297 0998-00-1800-101 EGK15006299 0998-00-1800-101 EGK15006302 0998-00-1800-201 EGN14005560 0998-00-1800-201 EGN14005889 0998-00-1800-101 EG-08000821 0998-00-1800-101 EG-09001590 0998-00-1800-101 EG-09001600 0998-00-1800-101 EG-09001610 0998-00-1800-101 EG-09001612 0998-00-1800-101 EG-09001617 0998-00-1800-101 EG-09001621 0998-00-1800-101 EG-0B002492 0998-00-1800-101 EGK11002620 0998-00-1800-101 EGK12002944 0998-00-1800-101 EGK12002945 0998-00-1800-101 EGK12002967 0998-00-1800-101 EGK12002990 0998-00-1800-101 EGK12002992 0998-00-1800-101 EGK13003806 0998-00-1800-101 EGK13003825 0998-00-1800-101 EGK13003834 0998-00-1800-101 EGK13003854 0998-00-1800-101 EGK13004293 0998-00-1800-101 EGK14005464 0998-00-1800-101 EGK14005909 0998-00-1800-101 EGK14005917 0998-00-1800-101 EGK14005919 0998-00-1800-201 EGN12002923 0998-00-1800-201 EGN12002927 0998-00-1800-201 EGN13003759 0998-00-1800-201 EGN13003764 0998-00-1800-201 EGN13003768 0998-00-1800-201 EGN13003791 0998-00-1800-201 EGN13003795 0998-00-1800-201 EGN13003797 0998-00-1800-201 EGN14005529 0998-00-1800-101 EGK13004251 0998-00-1800-101 EGK13004259 0998-00-1800-101 EGK13004263 0998-00-1800-101 EGK13004280 0998-00-1800-101 EGK13004285 0998-00-1800-101 EGK14005436 0998-00-1800-101 EGK14005437 0998-00-1800-101 EGK14005484 0998-00-1800-101 EGK14005912 0998-00-1800-101 EGK15006292 0998-00-1800-101 EGK15006295 0998-00-1800-101 EGK15006303 0998-00-1800-101 EGK17007607 0998-00-1800-201 EGN14005522 0998-00-1800-201 EGN11002574 0998-00-1800-201 EGN11002578 0998-00-1800-201 EGN11002584 0998-00-1800-201 EGN11002588 0998-00-1800-201 EGN13004514 0998-00-1800-201 EGN13004518 0998-00-1800-201 EGN13004532 0998-00-1800-201 EGN13004544 0998-00-1800-201 EGN13004560 0998-00-1800-201 EGN14005514 0998-00-1800-201 EGN14005518 0998-00-1800-201 EGN14005530 0998-00-1800-201 EGN14005555 0998-00-1800-201 EGN14005895 0998-00-1800-201 EGN13004537 0998-00-1800-201 EGN13004561 0998-00-1800-201 EGN14005875 0998-00-1800-201 EGN14005877 0998-00-1800-201 EGN14005878 0998-00-1800-201 EGN14005897 0998-00-1800-101 EG-08000768 0998-00-1800-101 EG-08000769 0998-00-1800-101 EG-08000771 0998-00-1800-101 EG-08000774 0998-00-1800-101 EG-08000775 0998-00-1800-101 EG-08000776 0998-00-1800-101 EG-08000779 0998-00-1800-101 EG-08000780 0998-00-1800-101 EG-08000783 0998-00-1800-101 EG-08000785 0998-00-1800-101 EG-08000787 0998-00-1800-101 EG-08000788 0998-00-1800-101 EG-08000789 0998-00-1800-101 EG-08000790 0998-00-1800-101 EG-08000791 0998-00-1800-101 EG-08000792 0998-00-1800-101 EG-08000793 0998-00-1800-101 EG-08000794 0998-00-1800-101 EG-08000795 0998-00-1800-101 EG-08000796 0998-00-1800-101 EG-08000797 0998-00-1800-101 EG-08000801 0998-00-1800-101 EG-08000802 0998-00-1800-101 EG-08000804 0998-00-1800-101 EG-08000805 0998-00-1800-101 EG-08000807 0998-00-1800-101 EG-08000808 0998-00-1800-101 EG-08000809 0998-00-1800-101 EG-08000810 0998-00-1800-101 EG-08000814 0998-00-1800-101 EG-08000815 0998-00-1800-101 EG-08000818 0998-00-1800-101 EG-08000819 0998-00-1800-101 EG-08000820 0998-00-1800-101 EG-08000822 0998-00-1800-101 EG-08000824 0998-00-1800-101 EG-09001572 0998-00-1800-101 EG-09001573 0998-00-1800-101 EG-09001574 0998-00-1800-101 EG-09001575 0998-00-1800-101 EG-09001576 0998-00-1800-101 EG-09001577 0998-00-1800-101 EG-09001578 0998-00-1800-101 EG-09001580 0998-00-1800-101 EG-09001581 0998-00-1800-101 EG-09001582 0998-00-1800-101 EG-09001583 0998-00-1800-101 EG-09001584 0998-00-1800-101 EG-09001585 0998-00-1800-101 EG-09001586 0998-00-1800-101 EG-09001587 0998-00-1800-101 EG-09001588 0998-00-1800-101 EG-09001589 0998-00-1800-101 EG-09001591 0998-00-1800-101 EG-09001592 0998-00-1800-101 EG-09001593 0998-00-1800-101 EG-09001594 0998-00-1800-101 EG-09001595 0998-00-1800-101 EG-09001597 0998-00-1800-101 EG-09001598 0998-00-1800-101 EG-09001599 0998-00-1800-101 EG-09001602 0998-00-1800-101 EG-09001603 0998-00-1800-101 EG-09001605 0998-00-1800-101 EG-09001606 0998-00-1800-101 EG-09001607 0998-00-1800-101 EG-09001608 0998-00-1800-101 EG-09001609 0998-00-1800-101 EG-09001611 0998-00-1800-101 EG-09001613 0998-00-1800-101 EG-09001614 0998-00-1800-101 EG-09001615 0998-00-1800-101 EG-09001618 0998-00-1800-101 EG-09001620 0998-00-1800-101 EG-09001622 0998-00-1800-101 EG-09001623 0998-00-1800-101 EG-09001624 0998-00-1800-101 EG-09001626 0998-00-1800-101 EG-09001627 0998-00-1800-101 EG-0B002485 0998-00-1800-101 EG-0B002487 0998-00-1800-101 EG-0B002488 0998-00-1800-101 EG-0B002489 0998-00-1800-101 EG-0B002493 0998-00-1800-101 EG-0B002494 0998-00-1800-101 EG-0B002496 0998-00-1800-101 EG-0B002497 0998-00-1800-101 EG-0B002501 0998-00-1800-101 EGK0C002568 0998-00-1800-101 EGK11002608 0998-00-1800-101 EGK11002610 0998-00-1800-101 EGK11002611 0998-00-1800-101 EGK11002614 0998-00-1800-101 EGK11002616 0998-00-1800-101 EGK11002624 0998-00-1800-101 EGK11002629 0998-00-1800-101 EGK11002631 0998-00-1800-101 EGK11002632 0998-00-1800-101 EGK11002633 0998-00-1800-101 EGK12002941 0998-00-1800-101 EGK12002942 0998-00-1800-101 EGK12002943 0998-00-1800-101 EGK12002946 0998-00-1800-101 EGK12002947 0998-00-1800-101 EGK12002948 0998-00-1800-101 EGK12002949 0998-00-1800-101 EGK12002950 0998-00-1800-101 EGK12002952 0998-00-1800-101 EGK12002953 0998-00-1800-101 EGK12002954 0998-00-1800-101 EGK12002955 0998-00-1800-101 EGK12002956 0998-00-1800-101 EGK12002957 0998-00-1800-101 EGK12002958 0998-00-1800-101 EGK12002959 0998-00-1800-101 EGK12002960 0998-00-1800-101 EGK12002961 0998-00-1800-101 EGK12002962 0998-00-1800-101 EGK12002963 0998-00-1800-101 EGK12002964 0998-00-1800-101 EGK12002965 0998-00-1800-101 EGK12002966 0998-00-1800-101 EGK12002968 0998-00-1800-101 EGK12002969 0998-00-1800-101 EGK12002970 0998-00-1800-101 EGK12002971 0998-00-1800-101 EGK12002972 0998-00-1800-101 EGK12002973 0998-00-1800-101 EGK12002974 0998-00-1800-101 EGK12002975 0998-00-1800-101 EGK12002976 0998-00-1800-101 EGK12002977 0998-00-1800-101 EGK12002978 0998-00-1800-101 EGK12002979 0998-00-1800-101 EGK12002980 0998-00-1800-101 EGK12002981 0998-00-1800-101 EGK12002982 0998-00-1800-101 EGK12002983 0998-00-1800-101 EGK12002984 0998-00-1800-101 EGK12002985 0998-00-1800-101 EGK12002986 0998-00-1800-101 EGK12002987 0998-00-1800-101 EGK12002988 0998-00-1800-101 EGK12002989 0998-00-1800-101 EGK12002991 0998-00-1800-101 EGK12002993 0998-00-1800-101 EGK13003807 0998-00-1800-101 EGK13003808 0998-00-1800-101 EGK13003809 0998-00-1800-101 EGK13003810 0998-00-1800-101 EGK13003811 0998-00-1800-101 EGK13003812 0998-00-1800-101 EGK13003813 0998-00-1800-101 EGK13003814 0998-00-1800-101 EGK13003815 0998-00-1800-101 EGK13003816 0998-00-1800-101 EGK13003817 0998-00-1800-101 EGK13003818 0998-00-1800-101 EGK13003819 0998-00-1800-101 EGK13003820 0998-00-1800-101 EGK13003821 0998-00-1800-101 EGK13003822 0998-00-1800-101 EGK13003823 0998-00-1800-101 EGK13003826 0998-00-1800-101 EGK13003827 0998-00-1800-101 EGK13003828 0998-00-1800-101 EGK13003829 0998-00-1800-101 EGK13003830 0998-00-1800-101 EGK13003831 0998-00-1800-101 EGK13003832 0998-00-1800-101 EGK13003833 0998-00-1800-101 EGK13003835 0998-00-1800-101 EGK13003836 0998-00-1800-101 EGK13003837 0998-00-1800-101 EGK13003838 0998-00-1800-101 EGK13003839 0998-00-1800-101 EGK13003840 0998-00-1800-101 EGK13003841 0998-00-1800-101 EGK13003842 0998-00-1800-101 EGK13003843 0998-00-1800-101 EGK13003844 0998-00-1800-101 EGK13003845 0998-00-1800-101 EGK13003846 0998-00-1800-101 EGK13003847 0998-00-1800-101 EGK13003848 0998-00-1800-101 EGK13003849 0998-00-1800-101 EGK13003851 0998-00-1800-101 EGK13003852 0998-00-1800-101 EGK13003853 0998-00-1800-101 EGK13003855 0998-00-1800-101 EGK13003856 0998-00-1800-101 EGK13003857 0998-00-1800-201 EG-08000729 0998-00-1800-201 EG-08000733 0998-00-1800-201 EG-08000737 0998-00-1800-201 EG-08000738 0998-00-1800-201 EG-08000746 0998-00-1800-201 EG-08000748 0998-00-1800-201 EG-08000750 0998-00-1800-201 EG-08000753 0998-00-1800-201 EG-08000759 0998-00-1800-201 EG-08000760 0998-00-1800-201 EG-08000764 0998-00-1800-201 EG-08000765 0998-00-1800-201 EG-09001826 0998-00-1800-201 EG-09001828 0998-00-1800-201 EG-09001831 0998-00-1800-201 EG-09001832 0998-00-1800-201 EG-09001834 0998-00-1800-201 EG-09001836 0998-00-1800-201 EG-09001840 0998-00-1800-201 EG-09001844 0998-00-1800-201 EG-09001845 0998-00-1800-201 EG-09001846 0998-00-1800-201 EG-09001847 0998-00-1800-201 EG-09001848 0998-00-1800-201 EG-09001852 0998-00-1800-201 EGN11002570 0998-00-1800-201 EGN11002571 0998-00-1800-201 EGN11002573 0998-00-1800-201 EGN11002576 0998-00-1800-201 EGN11002577 0998-00-1800-201 EGN11002579 0998-00-1800-201 EGN11002581 0998-00-1800-201 EGN11002582 0998-00-1800-201 EGN11002585 0998-00-1800-201 EGN11002586 0998-00-1800-201 EGN11002591 0998-00-1800-201 EGN11002593 0998-00-1800-201 EGN11002595 0998-00-1800-201 EGN11002597 0998-00-1800-201 EGN11002598 0998-00-1800-201 EGN12002884 0998-00-1800-201 EGN12002885 0998-00-1800-201 EGN12002886 0998-00-1800-201 EGN12002887 0998-00-1800-201 EGN12002888 0998-00-1800-201 EGN12002889 0998-00-1800-201 EGN12002890 0998-00-1800-201 EGN12002891 0998-00-1800-201 EGN12002892 0998-00-1800-201 EGN12002893 0998-00-1800-201 EGN12002894 0998-00-1800-201 EGN12002896 0998-00-1800-201 EGN12002899 0998-00-1800-201 EGN12002900 0998-00-1800-201 EGN12002901 0998-00-1800-201 EGN12002902 0998-00-1800-201 EGN12002903 0998-00-1800-201 EGN12002904 0998-00-1800-201 EGN12002906 0998-00-1800-201 EGN12002907 0998-00-1800-201 EGN12002908 0998-00-1800-201 EGN12002909 0998-00-1800-201 EGN12002910 0998-00-1800-201 EGN12002912 0998-00-1800-201 EGN12002914 0998-00-1800-201 EGN12002916 0998-00-1800-201 EGN12002917 0998-00-1800-201 EGN12002918 0998-00-1800-201 EGN12002920 0998-00-1800-201 EGN12002921 0998-00-1800-201 EGN12002922 0998-00-1800-201 EGN12002924 0998-00-1800-201 EGN12002925 0998-00-1800-201 EGN12002926 0998-00-1800-201 EGN12002928 0998-00-1800-201 EGN12002929 0998-00-1800-201 EGN12002930 0998-00-1800-201 EGN12002931 0998-00-1800-201 EGN12002932 0998-00-1800-201 EGN12002933 0998-00-1800-201 EGN12002934 0998-00-1800-201 EGN12002936 0998-00-1800-201 EGN12002938 0998-00-1800-201 EGN12002940 0998-00-1800-201 EGN13003760 0998-00-1800-201 EGN13003761 0998-00-1800-201 EGN13003762 0998-00-1800-201 EGN13003765 0998-00-1800-201 EGN13003767 0998-00-1800-201 EGN13003769 0998-00-1800-201 EGN13003770 0998-00-1800-201 EGN13003771 0998-00-1800-201 EGN13003772 0998-00-1800-201 EGN13003773 0998-00-1800-201 EGN13003774 0998-00-1800-201 EGN13003775 0998-00-1800-201 EGN13003776 0998-00-1800-201 EGN13003778 0998-00-1800-201 EGN13003779 0998-00-1800-201 EGN13003780 0998-00-1800-201 EGN13003781 0998-00-1800-201 EGN13003782 0998-00-1800-201 EGN13003783 0998-00-1800-201 EGN13003784 0998-00-1800-201 EGN13003785 0998-00-1800-201 EGN13003786 0998-00-1800-201 EGN13003788 0998-00-1800-201 EGN13003789 0998-00-1800-201 EGN13003790 0998-00-1800-201 EGN13003792 0998-00-1800-201 EGN13003793 0998-00-1800-201 EGN13003794 0998-00-1800-201 EGN13003796 0998-00-1800-201 EGN13003798 0998-00-1800-201 EGN13003799 0998-00-1800-201 EGN13003800 0998-00-1800-201 EGN13003801 0998-00-1800-201 EGN13003803 0998-00-1800-201 EGN13003805 0998-00-1800-201 EGN13003755 0998-00-1800-201 EGN13004513 0998-00-1800-201 EGN13004516 0998-00-1800-201 EGN13004519 0998-00-1800-201 EGN13004520 0998-00-1800-201 EGN13004525 0998-00-1800-201 EGN13004531 0998-00-1800-201 EGN13004534 0998-00-1800-201 EGN13004549 0998-00-1800-201 EGN13004558 0998-00-1800-201 EGN14005512 0998-00-1800-201 EGN14005516 0998-00-1800-201 EGN14005520 0998-00-1800-201 EGN14005523 0998-00-1800-201 EGN14005528 0998-00-1800-201 EGN14005532 0998-00-1800-201 EGN14005551 0998-00-1800-201 EGN14005554 0998-00-1800-201 EGN14005558 0998-00-1800-201 EGN14005562 0998-00-1800-201 EGN14005874 0998-00-1800-201 EGN14005882 0998-00-1800-201 EGN14005888 0998-00-1800-201 EGN14005890 0998-00-1800-101 EG-08000767 0998-00-1800-101 EGK14005491 0998-00-1800-101 EGK13004289 0998-00-1800-101 EGK14005434 0998-00-1800-101 EGK14005479 0998-00-1800-201 EG-08000740 0998-00-1800-201 EG-08000766 0998-00-1800-201 EG-09001825 0998-00-1800-201 EG-09001830 0998-00-1800-201 EG-09001838 0998-00-1800-201 EG-09001839 0998-00-1800-201 EG-09001843 0998-00-1800-201 EG-09001849 0998-00-1800-201 EGN13003756 0998-00-1800-201 EGN13003763 0998-00-1800-201 EGN13003802 0998-00-1800-201 EGN13004557 0998-00-1800-201 EGN14005513 0998-00-1800-201 EGN14005525 0998-00-1800-201 EGN14005543 0998-00-1800-201 EGN14005891 0998-00-1800-101 EGK14005490 0998-00-1800-201 EGN14005540 0998-00-1800-101 EGK13004250 0998-00-1800-101 EGK13004252 0998-00-1800-101 EGK13004258 0998-00-1800-101 EGK13004261 0998-00-1800-101 EGK13004262 0998-00-1800-101 EGK13004264 0998-00-1800-101 EGK13004270 0998-00-1800-101 EGK13004272 0998-00-1800-101 EGK13004276 0998-00-1800-101 EGK13004278 0998-00-1800-101 EGK13004282 0998-00-1800-101 EGK13004283 0998-00-1800-101 EGK13004286 0998-00-1800-101 EGK13004287 0998-00-1800-101 EGK13004294 0998-00-1800-101 EGK13004296 0998-00-1800-101 EGK13004298 0998-00-1800-101 EGK13004299 0998-00-1800-101 EGK13004301 0998-00-1800-101 EGK14005453 0998-00-1800-101 EGK14005457 0998-00-1800-101 EGK14005458 0998-00-1800-101 EGK14005459 0998-00-1800-101 EGK14005463 0998-00-1800-101 EGK14005467 0998-00-1800-101 EGK14005472 0998-00-1800-101 EGK14005482 0998-00-1800-101 EGK14005486 0998-00-1800-101 EGK14005488 0998-00-1800-101 EGK14005496 0998-00-1800-101 EGK14005899 0998-00-1800-101 EGK14005903 0998-00-1800-101 EGK14005907 0998-00-1800-101 EGK15006284 0998-00-1800-101 EGK15006286 0998-00-1800-101 EGK15006287 0998-00-1800-101 EGK15006289 0998-00-1800-101 EGK15006291 0998-00-1800-101 EGK15006293 0998-00-1800-101 EGK15006294 0998-00-1800-101 EGK15006300 0998-00-1800-101 EGK15006301 0998-00-1800-201 EG-08000742 0998-00-1800-201 EG-09001827 0998-00-1800-201 EG-09001851 0998-00-1800-201 EG-09001853 0998-00-1800-201 EGN12002905 0998-00-1800-201 EGN13003752 0998-00-1800-201 EGN13003753 0998-00-1800-201 EGN13003757 0998-00-1800-201 EGN13003758 0998-00-1800-201 EGN13003777 0998-00-1800-201 EGN13003787 0998-00-1800-201 EGN13004517 0998-00-1800-201 EGN13004538 0998-00-1800-201 EGN13004554 0998-00-1800-201 EGN13004555 0998-00-1800-201 EGN13004556 0998-00-1800-201 EGN14005508 0998-00-1800-201 EGN14005521 0998-00-1800-201 EGN14005524 0998-00-1800-201 EGN14005548 0998-00-1800-201 EGN14005552 0998-00-1800-201 EGN14005556 0998-00-1800-201 EGN14005559 0998-00-1800-201 EGN14005561 0998-00-1800-201 EGN14005871 0998-00-1800-201 EGN14005872 0998-00-1800-201 EGN14005879 0998-00-1800-201 EGN14005880 0998-00-1800-201 EGN14005881 0998-00-1800-201 EGN14005886 0998-00-1800-201 EGN14005887 0998-00-1800-201 EGN14005894 0998-00-1800-201 EGN14005898 0998-00-1800-101 EGK14005435 0998-00-1800-101 EGK14005451 0998-00-1800-101 EGK14005456 0998-00-1800-101 EGK14005468 0998-00-1800-101 EGK14005470 0998-00-1800-101 EGK14005494 0998-00-1800-101 EGK14005495 0998-00-1800-101 EGK14005500 0998-00-1800-101 EGK14005505 0998-00-1800-101 EGK14005905 0998-00-1800-201 EGN13004515 0998-00-1800-201 EGN14005535 0998-00-1800-201 EGN14005539 0998-00-1800-201 EGN14005883
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, by letters dated October 14, 2011 on October 17, 2011. Firm initiated recall is ongoing.
REASON
A system database corruption may occur that causes the V Series Monitor to reset.
VOLUME OF PRODUCT IN COMMERCE
542 units National; 153 units Internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) AngioDynamics BENEPHIT CV Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol]. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. Recall # Z-1112-2012;
 
2) AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol]. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. Recall # Z-1113-2012;
 
3) AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. Recall # Z-1114-2012
CODE
1) Lot # 550789;
2) Lot # 550790;
3) Lot # 551092
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letters on February 6, 2012.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device. Recall # Z-1125-2012
CODE
Software release 4.0.0
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Nederlands, Best, Netherlands, by letter dated January 20, 2012. Firm initiated recall is ongoing.
REASON                       
There maybe incorrect values in the diffusion/perfusion maps.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medisystems A Nxstage Company Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" Ref. Number: D9-2007MG. Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector. Recall # Z-1126-2012
CODE
Lot Numbers: 110914F7, 110920F2
RECALLING FIRM/MANUFACTURER
Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by letter on December 14, 2011.
Manufacturer: Kawasumi Laboraratories Inc., Nakhornrachasima, Thailand. Firm initiated recall is ongoing
REASON
Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle.
VOLUME OF PRODUCT IN COMMERCE
20,750 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system. Model number 10592457. Recall # Z-1127-2012
CODE
Serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated January 20, 2012. 
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.
REASON                       
There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deletion, this could result in deletion of unarchived data.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
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PRODUCT
1) Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection. Recall # Z-1128-2012;
 
2) DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell. Recall # Z-1129-2012
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zeiss, Carl Inc., Thornwood, NY, by visit and letter in late April 2011.  
Manufacturer: Carl Zeiss MicroImaging GmbH, Goettingen, Niedersachsen, Germany. Firm initiated recall is ongoing.
REASON
The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to prevent unintended exposure to Class 3B laser radiation.
VOLUME OF PRODUCT IN COMMERCE
111 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
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PRODUCT
1) 012011 Westphalia 16% Calf RU Dairy F5359GBS MEDICATED A Complete Grain Mix for Growing Calves***ACTIVE DRUG INGREDIENT Monensin***INGREDIENTS Processed Grain By-Products, Grain Products, Plant Protein Products, Molasses Products, Calcium Carbonate, Roughage Products, Lignin Sulfonate, Salt, Calcium Sulfate, Magnesium Oxide, Ferrous Sulfate, Cobalt Carbonate, Copper Sulfate, Calcium Iodate, Manganous Oxide, Manganese Sulfate, Zinc Oxide, Zinc Sulfate, Mineral Oil, Vitamin A Supplement, Vitamin D3 Supplement, Vitamin E Supplement, Menadione Sodium Bisulfite Complex, Riboflavin Supplement, Niacin, d-Calcium Pantothenate, Thiamine Mononitrate, Vitamin B12, Biotin, Pyrodoxine Hydrochloride, Folic Acid, Sodium Selenite, Vitamin A Acetate. Production Dates: 04/15/2011-09/20/2011 Product Code: F5359GBS20 Manufacturing Codes: PT24511 BLK. Recall # V-048-2012;
 
2) 100311 Westphalia Dairy 18 Calf RU F6956GBS MEDICATED A Complete Grain Mix for Growing Calves***ACTIVE DRUG INGREDIENT Monensin***INGREDIENTS Processed Grain By-Products, Plant Protein Products, Grain Products, Calcium Sulfate, Molasses Products, Lignin Sulfonate, Salt, Roughage Products, Magnesium Oxide, Ferrous Sulfate, Calcium Carbonate, Cobalt Carbonate, Copper Sulfate, Calcium Iodate, Manganous Oxide, Manganese Sulfate, Zinc Oxide, Zinc Sulfate, Mineral Oil, Sodium Selenite, d-alpha Tocopheryl Acetate, Vitamin A Supplement, Vitamin D3 Supplement, Vitamin E Supplement. Product Code: F6956GBS, Manufacturing Codes: PT27911 BLK. Recall # V-049-2012
CODE
No Lot Code
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADM Alliance Nutrition, Inc., Quincy, IL, by telephone and visit on October 5, 2011.
Manufacturer: ADM Alliance Nutrition, Inc., Portland, MI. Firm initiated recall is ongoing.
REASON
Higher than normal sulfur levels were found in custom made feed.
VOLUME OF PRODUCT IN COMMERCE
59 tons( F5359GBS); 4 tons ( F6956GBS)
DISTRIBUTION
MI
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
Charlee Bear Dog Treats With Cheese and Egg, Net WT 16 oz (453g). Recall # V-050-2012
CODE
Best Before Sep. 30 13, Lot # 11HA0909
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wixon, Inc., St Francis, WI, by letter dated December 23, 2011.
Manufacturer: Apak Inc., Mundelein, IL. Firm initiated recall is ongoing.
REASON
Product came into contact with a solution used in the packaging cleaning process when the product was packaged by a third party contractor, Apak Inc. An initial toxicology assessment of the affected product revealed no health hazard.
VOLUME OF PRODUCT IN COMMERCE
1400 cases
DISTRIBUTION
Nationwide and Canada
 
END OF ENFORCEMENT REPORT FOR MARCH 7, 2012.
 
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