Safety
Enforcement Report for March 2, 2011
March 2, 2011 11-09
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) ValuMarket Beer Cheese Spread, 8 oz plastic container; UPC 0 28260 12501 1. Recall # F-0475-2011;
2) Mooney's Kentucky Bourbon Cheese, 8 oz plastic container; UPC 8 28260 10038 0. Recall # F-0476-2011
CODE
1) Lot 91610 Sell by 11-16-2010, Lot 92810 Sell By 11-28-10, Lot 101810 Sell By 12-18-2010, Lot 102210 Sell By 12-22-10, Lot 111210 Sell By 01/12/11, Lot 112610 Sell By 01/26/11, Lot 121310 Sell By 03/13/11, Lot 011411 Sell By 04/14/11, Lot 011711 Sell By 04/17/2011;
2) Lot 010511 Sell By 04/05/2011, Lot 012111, Sell By 04/19/11
RECALLING FIRM/MANUFACTURER
Shuckmans Fish Company & Smokery, Louisville, KY, by telephone on January 27, 2011 and by letters on January 28, 2011. Firm initiated recall is ongoing.
REASON
Products are being recalled due to undeclared soy.
VOLUME OF PRODUCT IN COMMERCE
132 cs/8 oz tubs + 2/8 oz tubs
DISTRIBUTION
KY
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PRODUCT
1) Products are soft cheeses made from cow milk. The cheeses are in wheels and/or cut pieces. There is no labeling or coding. The wheels of cow and sheep cheeses are wrapped in chestnut leaves and secured with twine. The wheels of goat cheese are wrapped in grape leaves and secured with twine. Recall # F-0477-2011;
2) Products are soft cheeses made from goat milk. The cheeses are in wheels and/or cut pieces. There is no labeling or coding. The wheels of cow and sheep cheeses are wrapped in chestnut leaves and secured with twine. The wheels of goat cheese are wrapped in grape leaves and secured with twine. Recall # F-0478-2011;
3) Products are soft cheeses made from sheep milk. The cheeses are in wheels and/or cut pieces. There is no labeling or coding. The wheels of cow and sheep cheeses are wrapped in chestnut leaves and secured with twine. The wheels of goat cheese are wrapped in grape leaves and secured with twine. Recall # F-0479-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Sally Jackson Cheeses, Oroville, WA, by telephone beginning December 17, 2010, press release on December 18, 2010 and by letters beginning on January 20 and 21, 2010. FDA initiated recall is ongoing.
REASON
Product may be contaminated with E. coli O157:H7.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
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PRODUCT
1) All lots of the following cheeses supplied by Sally Jackson to Whole Foods: Cow's Milk cheese and Cow's Milk Cheese wrapped in chestnut leaves. Sally Jackson Brand cheese was cut and re-packaged using a clear plastic wrap with a Whole Foods Market scale label. Recall # F-0480-2011;
2) All lots of the following cheeses supplied by Sally Jackson to Whole Foods: Goat's Milk cheese and Goat's Milk Cheese wrapped in grape leaves. Sally Jackson Brand cheese was cut and re-packaged using a clear plastic wrap with a Whole Foods Market scale label. Recall # F-0481-2011;
3) Sheep's Milk cheese and Sheep's Milk Cheese wrapped in chestnut leaves. Sally Jackson Brand cheese was cut and re-packaged using a clear plastic wrap with a Whole Foods Market scale label. Recall # F-0482-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Brand 365, LLC, Austin, TX, by press release and by e-mail on December 20, 2010.
Manufacturer: Sally Jackson Cheeses, Oroville, WA. Firm initiated recall is ongoing.
REASON
Product has the potential to contain Escherichia coli O157:H7.
VOLUME OF PRODUCT IN COMMERCE
82 lbs
DISTRIBUTION
CA, NV, WA, and Washington, DC
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PRODUCT
Cilantro, Bunched. Bunch Tied/Band: CILANTRO #4889 PRODUCT OF USA, UPC 0 33383 80104 9. Case Labeling - Side: "Sanwa Greenhouses FINEST QUALITY ." Case Labeling - End: "CILANTRO 30 BUNCH; ITALIAN PARSLEY 30 BUNCH; BOK CHOY 15 LB.; CELERY CABBAGE 15 LB.; KOHLRABI 12 BUNCH; CURLY PARSLEY 30 BUNCH; NAPPA 15 LB. PRODUCT OF U.S.A. FDACS identified Lot as 11 10 10 / 8405. Firm stated Cilantro has 5-7 days shelf life. Recall # F-0483-2011
CODE
Lot: 11 10 10 8705
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sanwa Fresh Produce Co, LLC, Tampa, FL, by telephone on November 24, 2010.
Manufacturer: Pismo Oceano Vegetable Exchange, Oceano, CA. Florida initiated recall is complete.
REASON
Product tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,880 bunches
DISTRIBUTION
FL
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PRODUCT
1) Mariegold Baking White Bread; 24 oz; UPC# 0-25202-78011-6. Recall # F-0485-2011;
2) Vallarta Premium White Bread; 24 oz; UPC# 6-65782-00082-4. Recall # F-0486-2011
CODE
Code Dates: Feb. 2, Feb. 3 and Feb. 5
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unified Grocers, Los Angeles, CA, by letters and visit on January 27, 2011 and by press release on January 28, 2011.
Manufacturer: Bakery Facility-Unified Grocers LA, Los Angeles, CA. Firm initiated recall is ongoing.
REASON
Product may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
2,411 units
DISTRIBUTION
AZ, CA, NV
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
Keebler Fudge Shoppe Jumbo Fudge Sticks Keebler, 8 1.1 oz. cookies, Keebler, UPC 30100 53332. Recall # F-0474-2011
CODE
Better if used before July 27 2011 on carton, AS 07 27 1 A on individual packages
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Company, Battle Creek, MI, by letter and press release on January 27, 2011.
Manufacturer: Bremner Food Group West Facility, Ripon, WI. Firm initiated recall is ongoing.
REASON
The product contains peanut butter but it is packaged in the wrong carton which does not declare peanuts as an ingredient. The label does state may contain peanuts.
VOLUME OF PRODUCT IN COMMERCE
2,812 cases of 16,872 cartons (8 count per carton)
DISTRIBUTION
Nationwide
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PRODUCT
Super Detox Tea for Dieters is sold under the trademark "Detoxapure". The product is packaged in a green cardboard box containing 30 herbal tea bags, Net Wt. 2.64 oz (75g). One serving size (one tea bag) consists of 2.5g of Detoxapure Proprietary blend (Senna Leaf, Licorice Root, Sweet Orange Peel, Stevia Herb, Papaya Leaf, Allhea Flower, Ginseng Root, Honeysuckle, Chamomile, Uva Ursi Leaf, Juniper Berry, Parsley Seed). --- Directions to use: Place one tea bag into cup and add 6-8 ounces of boiling water. Let steep for 3-6 minutes to allow herbs to become fully infused. Remove bag from cup, pressing gently to enhance flavor. After tasting, sweeten as desired. Product number 16770, UPC 7 66443 16770 9. Recall # F-0484-2011
CODE
Lot number 2931004C (Expiration 10/2014)
RECALLING FIRM/MANUFACTURER
Recalling Firm: NBTY, Inc., Bohemia, NY, by telephone and letter beginning February 8, 2011.
Manufacturer: Custom Co-Pak, LLC, Philadelphia, PA. Firm initiated recall is ongoing.
REASON
Testing performed on a sample showed that it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1561 boxes
DISTRIBUTION
Nationwide
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PRODUCT
Bacon Type Pellets, in poly twist tied plastic package inside cardboard box. Various package sizes from 5 - 66 lbs. Recall # F-0487-2011
CODE
Lot #26710-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whitefeather Foods, Wapakoneta, OH, by letters on January 24, 2011.
Manufacturer: Pablo Ignacio Michel Ontiveros Grupo Industrial Michel, Guadalajara, Mexico. FDA initiated recall is ongoing.
REASON
Product not properly labeled. Specific artificial food grade colors (FD&C Yellow No. 6, Yellow #5, Red #40, and Blue #2) were not properly declared on the finished package label.
VOLUME OF PRODUCT IN COMMERCE
1,763 lbs
DISTRIBUTION
GA, IN, KY, MS, NC, OK, SC, TN, VA
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
1) MAXI-PEEL 0.010%/2% Solution (tretinoin hydroquinone) Exfoliant Anti-Acne Depigmenting Agent 1, 60 mL, For external use only. Recall # D-256-2011;
2) MAXI-PEEL 0.025%/2% Solution (tretinoin hydroquinone) Exfoliant Anti-Acne Depigmenting Agent 2, 60 mL, For external use only. Recall # D-257-2011;
3) MAXI-PEEL 0.025%/4% (tretinoin hydroquinone) Exfoliant Anti-Acne Depigmenting Agent 3, 60 mL. For external use only. Recall # D-258-2011
CODE
1) Outer case Lot # 402683; individual bottle Lot # 90904B;
2) Outer case Lot # 400116; individual bottle Lot # 99105A;
3) Outer case Lot # 400118; individual bottle Lot # 90923B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Global Marketing Enterprises, Chicago, IL, by letters on July 16, 2010.
Manufacturer: Splash Pharmaceutical Corp., Valenzuela City, Philippines. Firm initiated recall is ongoing.
REASON
Marketed without an approved NDA/ANDA: Products were found to contain the drug substances, tretinoin and hydroquinone and are being marketed without an approved NDA/ANDA.
VOLUME OF PRODUCT IN COMMERCE
5,850 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Nifediac CC (nifedipine), Extended Release Tablets, USP 30 mg, 10 tablets per blister pack (NDC 0093-5272-19), packaged in a 100 unit dose tablets box (10 x 10s), Rx only, NDC 0093-5272-93. Recall # D-270-2011;
2) Nifediac CC (nifedipine), Extended-release Tablets, USP 60 mg, 10 tablets per blister pack (NDC 0093-1022-19), packaged in a 100 unit dose tablets box (10 x 10s), Rx only, NDC 0093-1022-93. Recall # D-271-2011;
3) Nifediac CC (nifedipine), Extended-release Tablets, USP 90 mg, 10 tablets per blister pack (NDC 0093-1023-19), packaged in a 100 unit dose tablets box (10 x 10s), Rx only, NDC 0093-1023-93. Recall # D-272-2011
CODE
1) Lot numbers: 0901T20A, Exp 12/2010; 0905T11A, Exp 4/2011, 0909T06A, Exp 6/2011; 0912T16A, Exp 11/2011;
2) Lot numbers: 0905T12A, Exp 2/2011; 0908T06A, Exp 6/2011;
3) Lot number: 0907T08A, Exp 4/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on November 30, 2010.
Manufacturer: Biovail International Corp., Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements; lot recalled out of abundance of caution per firm.
VOLUME OF PRODUCT IN COMMERCE
7,317
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Alternagel Liquid (Aluminum hydroxide), 600mg, 12 fl oz bottles, Johnson & Johnson, UPC 716837860129. Recall # D-259-2011;
2) Mylanta Maximum Strength Liquid, (Aluminum hydroxide 400mg, Magnesium hydroxide 400mg and Simethicone 40mg), 12 fl oz bottles, Antacid, Anti Gas, Cherry Flavor, UPC 716837622123. Recall # D-260-2011;
3) Mylanta Maximum Strength Liquid, (Aluminum hydroxide 400mg, Magnesium hydroxide 400mg and Simethicone 40mg), 12 fl oz bottles, Antacid, Anti Gas, Mint Flavor, UPC 716837624127. Recall # D-261-2011;
4) Mylanta Maximum Strength Liquid (Aluminum hydroxide 400mg, Magnesium hydroxide 400mg and Simethicone 40mg), 5 fl oz bottles (bilingual label), 12 fl oz bottles, 12 fl oz trays and 24 fl oz bottles, Antacid, Anti Gas, Original Flavor, 5 oz - UPC 716837610557; 12 oz - UPC 716837652120; 12 oz tray - UPC 716837652151; and 24 oz - UPC 716837652243. Recall # D-262-2011;
5) Mylanta Regular Strength Liquid (Aluminum hydroxide 200mg, Magnesium hydroxide 200mg and Simethicone 20mg), Mint flavor, 12 fl oz bottles, UPC 716837629122. Recall # D-263-2011;
6) Mylanta Regular Strength, (Aluminum hydroxide 200mg, Magnesium hydroxide 200mg and Simethicone 20mg), Original flavor, 12 fl oz bottles, UPC 71683761020. Recall # D-264-2011;
7) Mylanta Supreme Tasting with Calcium Liquid, (Calcium carbonate 400mg and Magnesium hydroxide 135mg), 12 fl oz and 24 fl oz bottles, Cherry flavor, 12 oz - UPC 716837825128; 24 oz - UPC 716837825241. Recall # D-265-2011;
8) Mylanta Ultimate Strength Liquid, (Aluminum hydroxide 500mg and Magnesium hydroxide 500mg), 12 fl oz bottles, Cherry flavor, UPC 716837644125. Recall # D-266-2011;
9) Mylanta Ultimate Strength Liquid, (Aluminum hydroxide 500mg and Magnesium hydroxide 500mg), 12 fl oz bottles, Mint flavor, UPC 716837643128. Recall # D-267-2011
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Merck, Ft Washington, PA, by letters on November 29, 2010
Manufacturer: Johnson&Johnson Merck Consumer, Lancaster, PA. firm initiated recall is ongoing
REASON
Misbranded; alcohol content not displayed on front panel.
VOLUME OF PRODUCT IN COMMERCE
10,312,806 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Alclometasone Dipropionate Ointment USP, 0.05%, 15g (NDC 68462-299-17) 45g, (NDC 68462-299-47), and 60 g (NDC 68462-299-65) tubes, Rx only. Recall # D-268-2011
CODE
Lot numbers with exp dates 15 gm- 05902013 (10/2011), 05902016 (10/2011), 05902021 (10/2011), 05902274 (11/2011) 05902275 (11/2011), 05100597 (2/2012), 05100633 (3/2012), 05100634 (3/2012), 05100903 (5/2012)), 05100904 (5/2012) 45 gm- 05901619 (8/2011), 05902030 (10/2011), 05902031 (10/2011), 05102082 (10/2011), 05102265 (11/2011), 05102266 (11/2011), 05100564 (3/2012) 60 gm 05901617 (8/2011), 05902215 (11/2011), 05902216 (11/2011), 05902255 (11/2011), 05902263 (11/2011), 051002264 (11/2011), 05100562 (3/2012), 05100564 (3/2012), 05100569 (3/2012), 05100578 (3/2012), 05100579 (3/2012)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Generics Inc., USA, Mahwah, NJ, by letters on December 6, 2010.
Manufacturer: Glenmark Generics Ltd., Himachal Pradesh, India. Firm initiated recall is ongoing.
REASON
Exceeded Impurity Specification; 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
16,968 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Acetaminophen, tablets, 325 mg, 100 count bottle, distributed by: 19720, NDC 10135-123-01. Recall # D-269-2011
CODE
Lot #s: 3163, Exp 09/12; 3164, Exp 09/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Marlex Pharmaceuticals, Inc. New Castle, DE, by e-mails, letters and telephone beginning January 27, 2011.
Manufacturer: Cispharma Inc., Cranbury, NJ. Firm initiated recall is ongoing.
REASON
Discoloration: Product may exhibit areas of discoloration (black spots).
VOLUME OF PRODUCT IN COMMERCE
50,295 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0117-11
CODE
Unit: 3411653
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on November 10, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-0296-11
CODE
Units: 0141288768; 0141288456; 0141286796; 0141286209; 0141285873; 0141285367; 0141285076; 0141284524; 0141284239; 0141283603; 0141283296
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Tulsa, OK, by facsimile on August 2, 2006.
Manufacturer: CSL Plasma, Inc., Tulsa, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was allowed to donate without having a current physical, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0408-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0409-11
CODE
1) Unit: W120610082110;
2) Unit: W120610184827
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by fax on November 30, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0684-11
CODE
Unit: 192633057
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on March 9, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly stored in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0783-11
CODE
Unit: 1618154
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0809-11
CODE
Unit: 7889313 Part 1
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on April 23, 2008. Firm initiated recall is complete.
REASON
Blood product, with positive bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0810-11
CODE
Unit: 7292800
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on March 17, 2008. Firm initiated recall is complete.
REASON
Blood product, subjected to routine aerobic/anaerobic bacterial screening procedures did not meet specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0812-11;
2) Recovered Plasma. Recall # B-0813-11
CODE
1) and 2) Unit: 0679506
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on May 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0814-11
CODE
Units: 5377826 Part 1; 5377826 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on January 7, 2008.
Manufacturer: Marin Center, San Rafael, CA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0815-11
CODE
Units: 5332698 Part 1; 5332698 Part 2
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on January 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0840-11
CODE
Units 381070540, 381070350, 381069984, 381069808, 381068965, 381068783, 381068313, 381068151, 381067718, 381067473, 381067140, 381066944, 381066586, 381066289, 381065935, 381064526, 381065364, 381064386, 381064220, 381063426, 381063033, 381062874, 381062488, 381061767, 381061614, 381061260, 381060375, 381060162, 381059688, 381059534, 381059093, 381058859, 381058451, 381058224, 381057903, 381057624, 381057317, 381057103, 381056525, 381055667, 381054442, 381054328, 381053845, 381053686, 381053078, 381052342, 381051924, 381051688, 381048523 and 381048512
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Research Triangle Park, NC, by facsimile on May 14, 2010.
Manufacturer: Talecris Plasma Resources, Peoria, IL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred due to a history of Dura Mater Graft, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0847-11
CODE
Units: 2561742; 2558507; 2555892; 2552399
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, TN, FL, MA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0848-11;
2) Red Blood Cells Leukocytes Reduced Washed. Recall # B-0849-11;
3) Recovered Plasma. Recall # B-0850-11
CODE
1) Units: 3618494; 2528285;
2) Unit: 3679207;
3) Units: 3679207; 3618494; 2528285
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated September 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0852-11
CODE
Units: 07FNCI7050, 08FNCD4478, 08FNCD2654, 08FNCC1491, 08FNCC0316, 08FNCB9726, 08FNCB8167, 08FNCB6366, 08FNCB4223, 08FNCB3095, 08FNCA6099, 08FNCA3904, 08FNCA0632, 07FNCJ2710, 07FNCJ0668, 07FNCI9532, 07FNCI7743, 07FNCJ1704, 07FNCD1134, 07FNCD1794, 07FNCD5580, 07FNCD7009, 07FNCE8709, 07FNCF1790, 07FNCF3666, 07FNCF4640, 07FNCF7691, 07FNCG1530, 07FNCG5367, 07FNCH4628, 07FNCH5671, 07FNCH6671, 07FNCH7900, 07FNCH8862, 07FNCI2975, 07FNCI3724, 07FNCI5347, 07FNCI6012, 07FNCH0714, 07FNCD4729, 07FNCD8409, 07FNCE6473, 07FNCE9588, 07FNCF5345, 07FNCF6515, 07FNCH2481, 07FNCI0896, 07FNCI1610
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fayetteville, NC, by facsimile on September 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not had a current physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0853-11
CODE
Units: 2416881 and 3662491
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0854-11;
2) Recovered Plasma. Recall # B-0855-11
CODE
1) and 2) Unit: P47416
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter and telephone on June 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0856-11
CODE
Unit: 2677777
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on July 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0857-11
CODE
Unit: V39119
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on June 3, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-0858-11
CODE
Unit: S80835 ([Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on January 31, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a door whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0920-11
CODE
Unit: 05GNCE2952, 05GNCE3839, 05GNCE5035, 05GNCE6765, 05GNCE8321, 05GNCE8839, 05GNCF0065, 05GNCF3732, 05GNCF4674, 05GNCF5328, 05GNCF7022, 05GNCF7520, 05GNCF8471, 05GNCF9022, 06GNCA4129, 06GNCA4842, 06GNCA5448, 06GNCB0314, 06GNCB0740, 06GNCB1441, 06GNCB2626, 06GNCB5107, 06GNCB5742, 06GNCB6717, 06GNCB8139, 06GNCC1203, 06GNCC1615, 06GNCC3548, 06GNCD1908, 06GNCD2024, 06GNCD3097, 06GNCD3954, 06GNCD4564, 06GNCD6518, 06GNCD6979, 06GNCD9082, 06GNCE0435, 06GNCE0920, 06GNCE1749, 06GNCE2216, 06GNCE3123, 06GNCE4714, 06GNCE5101, 06GNCE6055, 06GNCE6483, 06GNCE7507, 06GNCE7849, 06GNCE8826, 06GNCE9644, 06GNCF0074, 06GNCF1322, 06GNCF2254, 06GNCF2718, 06GNCF4053, 06GNCF4588, 06GNCF6036, 06GNCF7618, 06GNCF8229, 06GNCF8883, 06GNCF9285, 06GNCG0139, 06GNCG0704, 06GNCG1395, 06GNCG5453, 06GNCG5915, 07GNCA1898, 07GNCA2391, 07GNCA3237, 07GNCA4332, 07GNCA7928, 07GNCA9826
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Greensboro, NC, by facsimile on August 8, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
CA, MD
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0937-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0938-11
CODE
1) and 2) Units: 5367771; 5351557; 5381560
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on February 19, 2008.
Manufacturer: Peninsula Center, Millbrae, CA. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA, Austria
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Irradiated. Recall # B-0770-11;
2) Fresh Frozen Plasma. Recall # B-0771-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0772-11
CODE
1) Unit: 2877908;
2) Unit: 2877907; Unit: 2977908;
3) Unit: 2877907
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on August 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0801-11
CODE
Units: 7350242, 9348201, 9355942
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 5, 2008 and by letter dated February 22, 2008. Firm initiated recall is complete.
REASON
Blood products, for which red cell antigen testing was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0806-11
CODE
Unit: W047008273442
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone and fax on October 14, 2008.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood product, collected in an unacceptable blood collection set, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0807-11
CODE
Unit: 7741345 (BAG 1); 7741345 (BAG 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on February 27, 2008.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, which was possibly contaminated with dipthteroids, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) AS-3 Red Blood Cells Leukocytes Reduced. Recall # B-0838-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0839-11
CODE
1) Unit: 003KF35225 (split);
2) Units: 003S40360, 003S40361, 003S43066, 003KQ41355, 003KQ41368, 003KQ41375, 03KQ41387, 003KF35266, 003KF35222, 003KQ41357, 003KF35261, 003KF35272, 003KF35246, 003KF35248, 003KY43638, 003KY43640, 003KY43643, 003G46370, 003KF35214, 003KQ41089, 003S43051, 003S43054, 003S43062, 003KQ41380, 003KQ41384, 003KQ41354, 003KQ41364, 003KQ41366, 003S43058, 003S43065, 003S42985, 003KQ41363, 003S42977, 003KQ41377, 003KF35226, 003KY43637, 003S42978, 003S42980, 003S42981, 003S42989, 003KQ41361, 003KQ41362, 003KQ41376, 003S42972, 003S43046, 003KY43648, 003KY43651, 003S42970, 003S42971, 003S42988, 003KQ41353, 003KQ41356, 003KQ41372, 003KF35253, 003KF35257, 003KF35263, 003KF35276, 003KF35277, 003KF35284, 003KF35215, 003KF35240, 003KF35241, 003KF35250, 003G46375, 003G46381, 003G46393, 003KQ41091, 003KQ41081, 003KQ41080, 003G46377, 003G46380, 003G46385, 003G46392, 003G46367, 003KF35274, 003KF35278, 003KF35282, 003KF35286, 003KF35235, 003KF35191, 003KF35194, 003KF35202, 003KF35207, 003KF35210, 003KQ41352, 003KF35217, 003KF35234, 003G46383, 003G46367, 003G46394, 003S43047, 003S43048, 003S43049, 003KY43645, 003G46371, 003G46388, 003KF35290, 003KF35239, 003KF35243, 003KF35245, 003G46384, 003KF35242, 003KQ41378, 003KQ41383, 003KQ41386, 003KF35223, 003KF35237, 003KY43649, 003KQ41076, 003S43043, 003S42986, 003KQ41374, 003KQ41381, 003KF35270, 003KF35252, 003KF35201, 003KF35212, 003S43042, 003G46390, 003S43064, 003KQ41379, 003S43045, 003KF35265, 003KF35216, 003KF35249, 003KY43642, 003S42984, 003G46369, 003KF35260, 003KF35279, 003KF35287, 003KF35229, 003G46363, 003G46365, 003G46366, 003G46373, 003KF35264, 003KF35268, 003KF35319, 003KQ41371, 003KF35283, 003G46395, 003S43067, 003KY43644, 003S43052, 003S43055, 003S43057, 003S43059, 003KQ41382, 003KF35255, 003KF35267, 003KF35238, 003KF35251, 003KQ41087, 003G46376, 003G46379, 003KF35227, 003KF35280, 003KF35285, 003S42974, 003KF35273, 003KY43650, 003KF35218, 003KF35221, 003KF35224, 003KY43646, 003KY43647, 003KY43652, 003S42973, 003S42975, 003KF35275, 003KF35281, 003KF35258, 003S43053, 003KQ41358, 003KQ41359, 003KQ41370, 003KF35269, 003KQ41369, 003S543044, 003KY43653, 003S43979, 003G46382, 003KF35254, 003KF35232, 003KF35271
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA, by facsimile and letter on December 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales with unacceptable quality control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
188 units
DISTRIBUTION
CA, GA, SC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0841-11;
2) Fresh Frozen Plasma. Recall # B-0842-11;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-0843-11;
4) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0844-11;
5) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0845-11
CODE
1) Units: 49LL37679, 49KQ22549, 49KE09784, 049LL37678, 049LL37673, 049FL17430, 049W58670, 049GV42109, 049GV42110, 049GV42112, 049GV42115, 049K 76383, 049K76378, 049W58678, 049W68677, 049LL37677, 049FF65099, 049KE09781, 049FL17445, 049KS08448, 049FL17444, 049KS08449, 049KS08434, 049KS08431, 049KQ22550, 049KS08427, 049KE09777, 049KS08430, 049KS08451, 049LG94124, 049FL17435, 049M55105, 049M55106, 049M55108, 049M55103, 049M55099, 049FL17449, 049KS08428, 049FL17451, 049FL17441, 049W58675, 049FL17438, 049W58672, 049GV42113, 049FL17433, 049LL37675, 049FL17448, 049LL37681, 049FL17446, 049KE09771, 049KE09775, 049FL17437, 049FL17432, 049FL17440, 049FE20226, 049FL17429, 049FE20231, 049M55100, 049KS08450, 049KE09780, 049FL17450, 049LG94121, 049FL17439, 049FL17422, 049KE09785, 049KE09788, 049KQ22552, 049LL37667, 049LL37671, 049LG94122, 049KS08445, 049LL37674, 049FF65093, 049LR34538 (2), 049LG94108, 049LL37672, 049W58680, 049W58679, 049M55102, 049FF65098, 049K76377, 049KE09789, 049M55107, 049LG94112, 049K76380, 049K76381, 049LG94109, 049W58676;
2) Units: 049FF65095, 049FF65094, 049LG94123, 049KS08446, 049KQ22555, 049LG94117, 049FL17426, 049FF65097, 049FE20229, 049KS08435, 049LG94121, 049KS08449;
3) Units: 049FP26211, 049FP26212, 049KP10437, 049KP10438 (2), 049KP10440, 049KP10440 (2), 049FP26207, 049FP26207 (2), 049KP10436 (2), 049KP10438, 049FP26213, 049FP26206, 049FP26209, 049KP10436, 049FP26209 (2), 049FP26210;
4) Unit: 049FE20230;
5) Unit: 049FP26208
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Dallas, TX, by fax on November 21, 2007.
Manufacturer: American National Red Cross SW Region – HT, Tulsa, OK. Firm initiated recall is complete.
REASON
Blood products, inappropriately tested for West Nile Virus (WNV) using expired reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
Whole Blood Irradiated. Recall # B-0915-11
CODE
Units: 0664922, GK05699, GM01010
RECALLING FIRM/MANUFACTURER
University of Arkansas for Medical Sciences, Little Rock, AR, by telephone on May 14, 2007. Firm initiated recall is complete.
REASON
Blood products, which were improperly irradiated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Source Plasma. Recall # B-0928-11
CODE
Units: 378074325, 378058110, 378059744, 378067322, 378057067, 378058931, 378056927, 378070715, 378057021, 378059306, 378069845, 378067595, 378066083, 378055432, 378058774, 378066718, 378056025, 378057140, 378059534, 378070258, 378061870, 378071836, 378072044, 378072791, 378058515, 378058752, 378059929, 378054016, 378057071, 378058330, 378070347, 378071830, 378072136, 378072787, 378073627, 378065905, 378067085, 378060012, 378073662, 378068447, 378068958, 378084902, 378086762, 378068613, 378065148, 378060857, 378065452, 378066232, 378063660, 378089664, 378086563, 378068953, 378055457, 378061676, 378063079, 378060024, 378056728, 378062531, 378063120, 378060061, 378067721, 378059144, 378058994, 378060455, 378063058, 378086454, 378056773, 378065063, 378065410, 378074394, 378065092, 378072810, 378071401, 378058147, 378059133, 378064003, 378073175, 378059252, 378069585, 378053509, 378069180, 378066637, 378064416, 378059058, 378072202, 378061093, 378069274, 378063692, 378055429, 378059991, 378060438, 378056373, 378056813, 378058481, 378063829, 378070270, 378063708, 378059984, 378061838, 378074295, 378070828, 378056726, 378067262, 378069254, 378064148, 378059862, 378057985, 378058533, 378067106, 378058495, 378065622, 378054049, 378056547, 378064298, 378070555, 378066828, 378072042, 378060313, 378059295, 378060846, 378064006, 378065124, 378065574, 378059109, 378059110, 378059018, 378069156, 378066241, 378067111, 378057122, 378060864, 378065386, 378061125, 378066239, 378063110, 378063631, 378064574, 378066775, 378058667, 378060604, 378061757, 378067714, 378059262, 378058662, 378063073, 378063807, 378055040, 378058732, 378059999, 378058647, 378061085, 378061884, 378062021, 378063780, 378065429, 378072090, 378067076, 378070445, 378058593, 378061073, 378061751, 378072052, 378058321, 378056379, 378070174, 378067109, 378066631, 378055959, 378067091, 378060020, 378068676, 378062646, 378064723, 378059113, 378060303, 378064251, 378073703, 378052461, 378058081, 378059871, 378063630, 378065885, 378052386, 378063052, 378069161, 378069412, 378066146, 378063686, 378060840, 378062225, 378063852, 378058420, 378062070, 378063857, 378065656, 378067158, 378056377, 378067903, 378072134, 378065434, 378058524, 378078728, 378079120, 378084582, 378082171, 378082682, 378071920, 378074893, 378057063, 378064744, 378066088, 378066640, 378067547, 378056372, 378065850, 378062256, 378070551, 378070883, 378057106, 378070243, 378059918, 378062523, 378063722, 378066201, 378062265, 378063098, 378066830, 378067136, 378067748, 378065636, 378060866, 378061855, 378059240, 378059254, 378061874, 378063182, 378072218, 378059080, 378064285, 378070151, 378056834, 378069225, 378069055, 378065462, 378066850, 378089315, 378090236, 378059283, 378058074, 378064034, 378063668, 378061356, 378064036, 378082064, 378066629, 378070977, 378062252, 378062580, 378063199, 378058338, 378058717, 378063064, 378065822, 378066722, 378070941, 378065036, 378067536, 378056509, 378056542, 378070327, 378070676, 378061968, 378056523, 378056980, 378073696, 378064371, 378064418, 378065127, 378061126, 378061953, 378063066, 378055445, 378059995, 378063587, 378064729, 378062264, 378067530, 378056839, 378058760, 378089988, 378090349, 378082156, 378060619, 378081764, 378070183, 378072888, 378063055, 378074378, 378069269, 378069315, 378069030, 378069071, 378064476, 378073918, 378055447, 378062982, 378059135
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by letter on May 6, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
307 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0929-11
CODE
Units: 3620011647, 3620011838, 3620012064, 3620012206, 3620012527, 3620012869, 3620013584, 3620009340, 3620009433, 3620009005, 3620009668, 3620010594, 3620011117, 3620011198, 3620012014, 3620014092, 3620017001, 3620009782, 3620013618, 3620016280, 3620017437, 3620020154, 3620008849, 3620010103, 3620012070, 3620013279, 3620008249, 3620009871, 3620022413, 3620018799, 3620019326, 3620008270, 3620009667, 3620009763, 3620017071, 3620016083, 3620019403, 3620011176, 3620011528, 3620010770, 3620011668, 3620014181, 3620008048, 3620009334, 3620010755, 3620011320, 3620011546, 3620011665, 3620011901, 3620020728, 3620009947, 3620016660, 3620011093, 3620012461, 3620012867, 3620013038, 3620020553, 3620012089, 3620011258, 3620011300, 3620011946, 3620012902, 3620013066, 3620012092, 3620020612, 3620011621, 3620016030, 3620018780, 3620009459, 3620008809, 3620012795, 3620011332, 3620011538, 3620012561, 3620010778, 3620011201, 3620010840, 3620010596, 3620011006, 3620017460, 3620009007, 3620011328, 3620009887, 3620008357, 3620018560, 3620019294, 3620012888, 3620014293, 3620015312, 3620011762, 3620010774, 3620011265, 3620011348, 3620012581, 3620015456, 3620010264, 3620018050, 3620019394, 3620020113, 3620020367, 3620020621, 3620021404, 3620010834, 3620010278, 3620016056, 3620008882, 3620013662, 3620011469, 3620017946, 3620019577, 3620011119, 3620019063, 3620012195, 3620012428, 3620013049, 3620011613, 3620011834, 3620012419, 3620012580, 3620013298, 3620014304, 3620019329, 3620020130, 3620019428, 3620009043, 3620009454, 3620009752, 3620008383, 3620020667, 3620008064, 3620020412, 3620011351, 3620019331, 3620020403, 3620020111, 3620009136, 3620019374, 3620017027, 3620017410, 3620017611, 3620011534, 3620009780, 3620010256, 3620012587, 3620010173, 3620010271, 3620010626, 3620020544, 3620008856, 3620011683, 3620009952, 3620019075, 3620019340, 3620019536, 3620020726, 3620009661, 3620012793, 3620015561, 3620020730, 3620012602, 3620009773, 3620008092, 3620020105, 3620020095, 3620014532, 3620017440, 3620008886, 3620008961, 3620019332, 3620019641, 3620020125, 3620017230, 3620019527, 3620020738, 3620010999, 3620011244, 3620011663, 3620011944, 3620019066, 3620010276, 3620008286, 3620012599, 3620012236, 3620009345, 3620009677, 3620013294, 3620009457, 3620008300, 3620011922, 3620012397, 3620014119, 3620017195, 3620018054, 3620018249, 3620019377, 3620020616, 3620020357, 3620020624, 3620010836, 3620017424, 3620017646, 3620020137, 3620009870, 3620011846, 3620014095, 3620016385, 3620016832, 3620014190, 3620016697, 3620017455, 3620012164, 3620012605, 3620010107, 3620010274, 3620010758, 3620013845, 3620015460, 3620014099, 3620016050, 3620019574, 3620008389, 3620014186, 3620017948, 3620018112, 3620008275, 3620009776, 3620009874, 3520020636, 3620009165, 3620010120, 3620014188, 3620011649, 3620012381, 3620013243, 3620014318, 3620018115, 3620020785, 3620015709, 3620012074, 3620011489, 3620012210, 3620008380, 3620011639, 3620014861, 3620017887, 3620017403, 3620021413, 3620011642, 3620009142, 3620016894, 3620016988, 3620008988, 3620008385, 3620012203, 3620017212, 3620011863, 3620012439, 3620012593, 3620021309, 3620012420, 3620010764, 3620011736, 3620016995, 3620009764, 3620015671, 3620017224, 3620017619, 3620015999, 3620018819, 3620019560, 3620009446, 3620009562, 3620011822, 3620011561, 3620009009, 3620010110, 3620017450, 3620020122, 3620020414, 3620014777, 3620018815, 3620020652, 3620009654, 3620020093, 3620020609, 3620021400, 3620014679, 3620017074, 3620018069, 3620010129, 3620012218
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Huntsville, AL, by letter on November 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
291 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0930-11
CODE
Units: 229048590; 229048590; 229048590; 229048598; 229048598; 229048598
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on April 10, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0931-11
CODE
Units: 181200455; 181200455; 181200455; 181200456
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by letter on August 3, 2007. Firm initiated recall is complete.
REASON
Blood products, which were shipped at potentially unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NV
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs. Recall # Z-1260-2011
CODE
All Lots. Batch Numbers: CJM838,CJZ014, CJZ065, CJZ228, CJZ456, CJZ542, CJZ625, CJ6116, CJ6293, CJ6402, CJ6572, CJ6852, CJK043, CJK216, CJK330, CJK536, CJK659, CKM791, CKZ068, CKZ437, CKZ652, and CK6002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, letters dated, December 28, 2010, and December 29, 2010.
Manufacturer: Ethicon, Inc., Chihuah, Mexico. Firm initiated recall is ongoing.
REASON
The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
VOLUME OF PRODUCT IN COMMERCE
4,110 eaches
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker. Recall # Z-1371-2011;
2) Medstorm Adult Radiolucent Zoll Medical (Part # 16381. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient’s skin. When a patient requires defibrillation, cardio version or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker. Recall # Z-1372-2011
CODE
1) Lot Y-032709;
2) Lot # Y032709-1
RECALLING FIRM/MANUFACTURER
Heart Sync, Inc., Ann Arbor, MI, by letter dated December 23, 2010.
Manufacturer: Katecho Inc., Des Moines, IA. FDA initiated recall is ongoing
REASON
The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.
VOLUME OF PRODUCT IN COMMERCE
600 products (300 each)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
InfusO.R. Infusion Pump, an Rx syringe infusion pump; product codes 2L3100, 2L3100R, 2L3100U, 2L3100N, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Recall # Z-1378-2011
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated January 11, 2011.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures .53 inches �.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter.
VOLUME OF PRODUCT IN COMMERCE
39,725 units
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck. Recall # Z-1390-2011
CODE
All model number 1010 Universal Sleeved Slings. It cannot be determined whether each Sling is identified by an individual serial number.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Generic Medical Devices, Gig Harbor, WA, by letter dated February 14, 2011.
Manufacturer: J-PAC, LLC, Somersworth, NH. Firm initiated recall is ongoing.
REASON
Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs..
VOLUME OF PRODUCT IN COMMERCE
1711 were implanted and 389 remain at the firm
DISTRIBUTION
Nationwide and Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.
___________________________________
PRODUCT
Haemonetics CardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US. Recall # Z-1391-2011
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Haemonetics Corp., Braintree, MA, by letter on January 25, 2011. Firm initiated recall is ongoing.
REASON
Update Instructions for Use for the CardioPAT Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.
VOLUME OF PRODUCT IN COMMERCE
309 units
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden
___________________________________
PRODUCT
Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. Recall # Z-1393-2011
CODE
Lot Number: 2020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter beginning June 23, 2010.
Manufacturer: Amcor Flexibles Healthcare Inc., Mundelein, IL. Firm initiated recall is ongoing.
REASON
The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.
VOLUME OF PRODUCT IN COMMERCE
470 units
DISTRIBUTION
Nationwide, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico
___________________________________
PRODUCT
Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. Device Part Number (Model Number): 703309. Recall # Z-1394-2011
CODE
Serial Numbers: 93202512, 93202514, 93202526, 93202527
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Cardiovascular US Sales, LLC, Wayne, NJ, letter on October 4, 2010.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is complete.
REASON
A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY City
___________________________________
PRODUCT
Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift. Recall # Z-1396-2011
CODE
Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hill-Rom, Inc., Batesville, IN, by letter dated February 9, 2011.
Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.
REASON
Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada
___________________________________
PRODUCT
1) Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1402-2011;
2) Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1403-2011;
3) Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1404-2011;
4) Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1405-2011;
5) Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1406-2011;
6) Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 6000-651-300. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1407-2011;
7) Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1408-2011;
8) Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1409-2011;
9) Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1410-2011;
10) Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1411-2011;
11) Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1412-2011;
12) Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1413-2011;
13) Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1414-2011;
14) Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1415-2011;
15) Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1416-2011;
16) Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1417-2011;
17) Stryker Navigation System - Spine Map(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1418-2011;
18) Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1419-2011;
19) Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recalling # Z-1420-2011
CODE
1) Versions 1.0 and 1.1; all batches: GC400F3001; GC700F3001; GCN00F3002; GCU00F3002; GCV00F3002; H1800F3002; H1P00F3002; H1Q00F3002; H1V00F3002; H2600F3002; H2M00F3002; H2P00F3003; H3800F3003; H3D00F3003; H3G00F3003; H3T00F3003; H3U00F3003; H4C00F3003; H4Q00F3003; H5300F3003; H5800F3003; H6500F3003; H6600F3003; H6B00F3003; H6N00F3003; H7400F3003; H7R00F3003; H7X00F3003; H8700F3003; H9U00F3003; H9V00F3003; HA500F3003; HAH00F3003; HBF00F3003; HBL00F3003; HBN00F3003; HBU00F3003; HBW00F3003; HC300F3003; and HC600F3003;
2) Versions 1.0 and 1.1; all batches: H2200F3002; H3D00F3003; H7900F3003; H7P00F3003; H9U00F3003; and HC400F3003;
3) Versions 1.0 and 1.1; all batches: HCE00F3002; HCL00F3002; J2J00F3002; J2L00F3002; J3500F3002; J3K00F3002; J3T00F3002; J4100F3002; J4900F3002; J5500F3002; J5600F3002; J6500F3002; J6C00F3002; J7A00F3002; J8100F3002; J8C00F3002; J8S00F3002; J9300F3002; J9900F3002; JA600F3002; JBJ00F3002; JBT00F3002; JC100F3002; JCK00F3002; JCV00F3002; JCW00F3002; K1700F3002; K3400F3002; K3G00F3003; K3K00F3003; K3X00F3003; K4H00F3003; K5800F3003; K5L00F3003; K6A00F3003; K6F00F3003; K6W00F3003; K7200F3003; K7600F3003; K7900F3003; K8700F3003; K8A00F3003; K8T00F3003; K9200F3003; K9E00F3003; K9P00F3003; K9W00F3003; KA100F3003; KAE00F3003; KAP00F3003; KAT00F3003; KB500F3003; KBT00F3003; KC400F3003; KCG00F3003; KCX00F3003; L1B00F3003; L1E00F3003; L1K00F3003; L2800F3003; L3100F3003; L3B00F3003; L3G00F3003; L3S00F3003; L4700F3003; L5A00F3003; L5J00F3003; L6N00F3003; L6U00F3003; L7500F3003; L7K00F3003; L8P00F3003; L9P00F3003; LA500F3003; LAB00F3003; and LAD00F3003;
4) Versions 1.0 and 1.1; all batches: HCU00F3002; J1800F3002; J1B00F3002; J1H00F3002; J1R00F3002; J2400F3002; J2K00F3002; J2U00F3002; J4E00F3002; and K4100F3003;
5) Versions 1.0 and 1.1; all batches: HCE00F3002; J1A00F3002; and J2K00F3002;
6) Versions 1.0 and 1.1; all batches: J3H00F3002; J4H00F3002; and L5M00F3003;
7) Versions 1.0 and 1.1; all batches: J3500F3002; J4900F3002; JAQ00F3002; K2A00F3002; K7W00F3003; K8T00F3003; KB500F3003; KBT00F3003; L1E00F3003; L1S00F3003; L4700F3003; L6U00F3001; and L7V00F3003;
8) Versions 1.0 and 1.1; batch J3H00F3002;
9) Version 1.0; all batches: K1P00F3002; K1T00F3002; K2B00F3002; K4600F3004; K4G00F3004; K4L00F3004; K5700F3004; K5800F3004; K6A00F3004; K7300F3004; K7H00F3004; K8700F3004; K8T00F3004; K9800F3004; K9P00F3004; K9R00F3004; KA700F3004; KAE00F3004; KB500F3004; KC400F3004; KCH00F3004; KCU00F3004; L1B00F3004; L3300F3004; L5H00F3004; L5J00F3004; L6E00F3004; L6U00F3004; L6V00F3004; L7500F3004; L8900F3004; and L8C00F3004;
10) Version 1.0; all batches: K1M00F3002; K1P00F3002; K1T00F3002; K2L00F3002; K2S00F3003; K3C00F3003; K3Q00F3003; K4U00F3004; K5700F3004; K5L00F3004; K7H00F3004; K8K00F3004; L5J00F3004; and L6E00F3004;
11) Version 1.0; all batches: K1700F3001; K1800F3001; K1P00F3002; K3C00F3003; K4G00F3004; K9B00F3004; and L5L00F3004;
12) Version 1.0; all batches: K8T00F3004 and KB500F3004;
13) Version 1.0; all batches: K4600F3004; K4L00F3004; K6400F3004; K6K00F3004; K7D00F3004; K8700F3004; KB400F3004; KC400F3004; L1400F3004; L2500F3004; L3800F3004; L5300F3004; and L5J00F3004;
14) Version 1.0; all batches: K1P00F3002; K2300F3002; and L2900F3004;
15) Version 1.0; all batches: K8700F3004; KB300F3004; KC400F3004; L2500F3004; L4700F3004; and L4S00F3004;
16) All batches: K3X00F3016; K4700F3016; K5500F3016; K7X00F3016; K8S00F3016; K9100F3016; KBC00F3016; and L1V00F3016;
17) All batches: JCK00F3015; JCX00F3015; K1F00F3015; K2Q00F3016; K2R00F3016; K3A00F3016; K3H00F3016; K3K00F3016; K7F00F3016; K8S00F3016; K9100F3016; KA900F3016; KBC00F3016; L1C00F3016; L6H00F3016; and L7900F3016;
18) All batches: GCB00F3031; H1J00F3031; H2600F3031; H2N00F3031; H4B00F3031; and HBD00F3031;
19) All batches: HCA00F3010; J1E00F3010; J2100F3010; J3700F3010; J3L00F3010; J5D00F3010; J7X00F3010; K3A00F3010; K3L00F3010; K5500F3010; K7X00F3010; K8S00F3010; K9100F3010; KBD00F3010; L6H00F3010; L7900F3010; and L9A00F3010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letters on December 3, 2010.
Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing,
REASON
When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.
VOLUME OF PRODUCT IN COMMERCE
1,155 units
DISTRIBUTION
Nationwide, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
1) VEDCO CMPK Solution, each 500 mL of sterile aqueous solution contains 10.8 g calcium (as calcium borogluconate, equivalent to calcium gluconate 23.2%), 8.0 g potassium (as potassium chloride), 2.5 g phosphorus (as sodium hypophosphite . H2O), 1.6 g magnesium (as magnesium borogluconate), and 75.0 g dextrose . H2O, packaged in 500-ml. vials, RX, NDC 50989-639-16. Recall # V-106-2011;
2) RXV Products Hypertonic Saline Solution 7.2%, each 100 mL of sterile aqueous solution contains 7.2 g sodium chloride, packaged in 1000-ml. vials, RX. Recall # V-107-2011;
3) Vet Tek Electrolyte Solution with Dextrose, each 500 ml of sterile aqueous solution contains 12.50 g dextrose. H2O, 12.50 g sorbitol, 3.95 g sodium lactate, 2.40 g sodium chloride, 0.37 g potassium chloride, 0.21 g magnesium chloride. 6H2O, and 0.19 g calcium chloride. 2H2O, packaged in 1,000-ml. vials, RX, NDC 60270-862-20. Recall # V-108-2011
CODE
1) Lot 100128A1, Exp. Jan 2012;
2) Lot 090522A1, Exp. May 2011;
3) Lot 100420B1, Exp. Apr 2012
RECALLING FIRM/MANUFACTURER
Nova-Tech Inc., Grand Island, NB, by telephone on August 6, 2010 and follow-up e-mail and letters dated August 9, 2010. FDA initiated recall is ongoing.
REASON
The product was manufactured outside the validated sterilization process.
VOLUME OF PRODUCT IN COMMERCE
20532 / 500mL vials CMPK, 6818 / 100mL vials Saline, and 5256 / 1000mL vials Electrolyte
DISTRIBUTION
MO, TX
___________________________________
PRODUCT
ALBON (sulfadimethoxine) --- Not for Human Use --- 500mg --- 500 tablets --- NADA #15-102, UPC # 8721901785 ALBON (sulfadimethoxine) --- Not for Human Use --- 500mg ---100 tablets --- NADA #15-102. Recalling Firm: V-109-2011
CODE
Units: PF03022A and PF03022B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on January 4, 2011.
Manufacturer: Emcure Pharmaceuticals Limited, Pune, Maharashtra, India. Firm initiated recall is ongoing.
REASON
Mold was observed on some of the tablets.
VOLUME OF PRODUCT IN COMMERCE
Lot PF03022A: 808 bottles, Lot PF03022B: 147 bottles
DISTRIBUTION
Nationwide, PR, and Guam
___________________________________
PRODUCT
1) Priority Care Piperazine Paste Canine Anthelmintic; Piperazine (from Adipate) 2.70 g (20.8%); Net Contents: 13 grams (0.46 oz) pre-filled syringe; an OTC oral prime rib/beef flavored piperazine adipate paste wormer for puppies and adult dogs; for animal use only, Keep Out of Reach of Children; 1) Reorder No. OM125PC, NDC 58829-340-13, UPC 0 62308 34013 5; The dog wormer was packaged under the following private labels: a) Worm Protector Piperazine Paste-Canine Anthelmintic; 12 syringes per case, 2) Reorder No. OM125TW, NDC 64750-340-13, UPC 3 56561 00203 6; b) WormEze Paste Canine Anthelmintic; 24 syringes per case, 3) Reorder No. OM125DU, NDC 16579-923-85, UPC 7 45801 10540 9; c) Happy Jack Puppy Paste Canine Anthelmintic Paste (Piperazine Adipate); 4) Reorder No. OM125HJ, UPC 0 23851 01726 3; d) Hartz Ultra Guard Rid Worm Paste for Dogs and Puppies; 48 syringes per case, 5) Reorder No. OM125HM, NDC 032700-722, UPC 0 32700 01133 8; e) Worm Free Canine Anthelmintic; 6) Reorder No. OM125RXFC, NDC 64556-340-13, UPC 7 54629 50716 6. Recall # V-110-2011;
2) Priority Care Piperazine Paste Feline Anthelmintic; Piperazine (from Adipate) 800 mg (20%); Net Contents: 4 grams (0.14 oz) pre-filled syringe; an OTC oral grilled tuna flavored piperazine adipate paste wormer for kittens and adult cats; for animal use only, Keep Out of Reach of Children; 1) Reorder No. OM120PC, NDC 58829-341-04, UPC 3 62308 34104 0; The cat wormer was packaged under the following private labels: a) Worm Protector Piperazine Paste-Feline Anthelmintic; 2) Reorder No. OM120TW, NDC 64750-341-04, UPC 3 56561 00204 3; b) WormEze Paste Feline Anthelmintic; 3) Reorder No. OM120DU, NDC 16579-924-88, UPC 7 45801 10541 6; c) Happy Jack Kitty Kat Paste Feline Anthelmintic Paste; 4) Reorder No. OM120HJ, UPC 0 23851 01055 4; d) Hartz Ultra Guard Rid Worm Paste for Cats and Kittens; 5) Reorder No. OM120HM, NDC 032700-721, UPC 0 32700 01134 5; e) Worm Free Feline Anthelmintic; 6) Reorder No. OM120RXFC, NDC 64556-341-04, UPC 7 54629 50717 3. Recall # V-111-2011
CODE
1) 1) Lot number A1C; 2) Lot number A1C; 3) Lot numbers J1A, A2B, F1B, J1B and A1C; 4) Lot numbers J1A, A2B and A1C; 5) Lot numbers FT27481C, FT01491C and FT11101C; 6) Lot numbers J1A, A2B, F1B, J1B, A1C and F1C;
2) 1) Lot numbers K2A and B3C; 2) Lot numbers B3C and I1C; 3) Lot numbers K2A, A2B, F1B, K1B, B3C and I1C; 4) Lot number K1B; Reorder No. OM120HM, 5) Lot numbers FT26681F, FT31581F, FT32681F, FT30481F, FT33681F, FT33881F, FT34381F, FT34681F, FT01291F, FT08991F, FT12591F, FT18291F, FT21591F, FT25791F, FT31791F, FT33491F, FT03601F, FT04801F, FT06101F, FT07601F, FT08201F, FT15801F, FT16901F and FT25801F; 6) Lot numbers K2A, A2B, F1B, K1B, B3C and I1C
RECALLING FIRM/MANUFACTURER
First Priority, Inc., Elgin, IL, letters on November 24, 2010. Firm initiated recall is ongoing.
REASON
Both the canine and feline piperazine products failed post market stability testing due to high viscosity results, and in the case of the canine product, also out of specification high assay results.
VOLUME OF PRODUCT IN COMMERCE
146,605 syringes - dog and 961,075 syringes - cat
DISTRIBUTION
AL, IL, MO, NJ, NC, OH, PR, TX
END OF ENFORCEMENT REPORT FOR MARCH 2, 2011
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