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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 25, 2010

August 25, 2010                                                                                        10-33

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT   
Romaine Lettuce in bulk bins. Recall # F-2653-2010
CODE
Lot numbers 2-6E (Y267), 2-6M (Y266), 2-6W (Y264)1
RECALLING FIRM/MANUFACTURER
Andrew Smith Co., Salinas, CA, via e-mail and telephone on May 7, 2010. FDA Initiated recall is ongoing.
REASON
Product may be contaminated with e.coli O145. Related to Freshway Foods Recall, linked to outbreak.
VOLUME OF PRODUCT IN COMMERCE
1,331 cases
DISTRIBUTION
     OK, MA
___________________________________
PRODUCT   
Ice cream in 3 lb tubs with label reading in part: "DENALI BEAR CLAW Ingredients: milkfat and nonfat milk, corn syrup, sugar, buttermilk, butter, milk, cashews. Allergen Alert: Produced in plant that uses eggs, gluten, peanuts and other nuts. Item Number: 061041. Recall # F-2666-2010
CODE
Lot code: "10124" Breakdown: "10"=year 2010, "124"=Julian date (5/4/2110) No Expiration Date
RECALLING FIRM/MANUFACTURER
Oregon Ice Cream, LLC, Eugene, OR, by letters and press release on July 23, 2010. Firm initiated recall is ongoing.
REASON
Product contains undeclared peanut allergen.
VOLUME OF PRODUCT IN COMMERCE
641 3 gallon containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1) Specialty Farms Organic Alfalfa Sprouts Blend, 4 oz UPC 8192400108. Recall # F-2667-2010;

2) Specialty Farms Specialty Farms Organic Sprout Salad, 4 oz UPC 8192400024. Recall # F-2668-2010;

3) Natures Promise Organic Alfalfa Sprouts (4 oz) UPC: 8826704741 and Natures Promise Organic Alfalfa Sprouts (8 oz) UPC: 8826704102. Recall # F-2669-2010;

4) Natures Promise Organic Zesty Sprouts (4 oz) UPC: 8826703903. Recall # F-2670-2010
CODE
1) Best if sold by: 7/26/2010 and 8/3/2010;
2) Best if sold by: 7/26/2010 and 8/3/2010;
3) Best if sold by Date 8/1/2010;
4) Best if sold by Date 8/1/2010
RECALLING FIRM/MANUFACTURER
Specialty Farms LLC, Bridgeport, CT, by letter and press release on July 23, 2010 and July 29, 2010. Connecticut initiated recall is ongoing.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
2160 Units (180 cases (12 x 4 oz)
DISTRIBUTION
CT, NH, MA, ME, NJ, NY, PA, RI, VT
___________________________________
PRODUCT   
Kirkland Signature brand Milk Chocolate Salted Caramel Macadamia Clusters, Net Wt 2 lb (32 oz) 907g, ITEM 297671, UPC 0 96619 29767 2. PRODUCT OF USA. The product is packed in a wide mouth clear plastic jar with a purple screw top. The product is stacked on pallets containing 400 wide mouth plastic jars per pallet. Recall # F-2671-2010
CODE
Each jar is labeled with a production code as follows: BEST BEFORE MONTH DAY YEAR (Four Number Julian Date Military Time Jar Number) --- Recalled Julian Codes/BEST BEFORE Dates: Julian Code 0196 - BEST BEFORE MAR15 2011; Julian Code 0197 - BEST BEFORE MAR16 2011; Julian Code 0198 - BEST BEFORE MAR17 2011; Julian Code 0199 - BEST BEFORE MAR18 2011; Julian Code 0200 - BEST BEFORE MAR19 2011; Julian Code 0201 - BEST BEFORE MAR20 2011; Julian Code 0202 - BEST BEFORE MAR21 2011    
RECALLING FIRM/MANUFACTURER
DeMet's Candy Co., Stamford, CT, by letter and e-mail on August 4, 2010. Firm initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella based on private laboratory testing.
VOLUME OF PRODUCT IN COMMERCE
35,200 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT   
Alfalfa Sprouts labeled and packaged as follows: Nature's Choice - 4 oz plastic cups; California Exotics brands - 5 oz plastic clamshell containers; Caldwell Fresh Foods - 4 oz plastic cups, 1 lb plastic bags, 2 lb and 5 lb plastic bags in cardboard boxes with sticker affixed with the printed words Caldwell Fresh Foods. Note: Caldwell Fresh Foods alfalfa sprouts not affected by this recall will have a bright, round, green sticker affixed to the lids and labels. Recall # F-2678-2010
CODE
All lot/date codes
RECALLING FIRM/MANUFACTURER
Caldwell & Son, Inc DBA Choice Pak, Maywood, CA, by telephone beginning on May 20, 2010 and press release, e-mail and or fax on May 21, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated because the alfalfa sprouts may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
212,192 units
DISTRIBUTION
CA, NV, AZ
___________________________________
PRODUCT
Claw Island and Inland Ocean brand: Lobster Claw & Knuckle Meat, Frozen 2 lb. Vacuum packed polyethylene bags packed in cardboard master cases. Recall # F-2797-2010
CODE
Lot code: 07410R
RECALLING FIRM/MANUFACTURER
Portland Shellfish dba Claw Island Foods, Portland, OR, by telephone on April 9, 2010 and follow-up letter. Firm initiated recall is complete.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
114 cases
DISTRIBUTION
CA, NY
_________________________________
PRODUCT
Product is a blend of 19.6 lbs individually quick frozen (IQF) cut corn and 0.4 lbs roasted, diced IQF poblano peppers in 20 lb bag inside of carton labeled in part: "20 LBS. NET WT. (9.07 kg)***3901751007***PRODUCT OF USA CORN AND POBLANO BLEND FRAGILE STORE AT 0' F OR BELOW INGREDIENTS: CORN, POBLANO PEPPERS. " Recall # F-2798-2010
CODE
Lot numbers: "3901751007" or "3901741007" appears on outside carton. Code breakdown: 390=the manufacturing location (Pasco, WA) 175=Julian date of manufacture (June 24) 10=production year (2010) 07=the production line SKU number: 10071179017738
RECALLING FIRM/MANUFACTURER
Pasco Processing LLC, Pasco, WA, by telephone on July 19, 2010 and by press release on July 23, 2010.  Firm initiated recall is ongoing.
REASON
Product tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
2,087 cases
DISTRIBUTION
CA, AZ

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT   
1) Dawn's Deluxe Seafood Salad, Net Wt. 14 oz item #40014. Keep Refrigerated. Contains Milk, Egg Wheat & Soy. UPC: 32345 80014. Recall # F-2663-201;

2) Dawn's Vidalia Onion Dip, Net Wt. 5 lbs. (2.27 kg) item #61180 UPC 32345 61180 and Dawns Five Star Dips Vidalia Onion Dip item #61169 UPC 32345 61169. Keep Refrigerated. Contains Milk & Soy. Recall # F-2664-2010
CODE
1) Expiration dates: 7/7/10C, 7/14/10D;

2) Expiration dates: 6/3/10, 6/11/10, 6/24/10, 6/26/10, 7/1/10, 7/5/10, 7/14/10A, 7/28/10A, 7/28/10C, 8/11/10B, 8/18/10A, 8/25/10A, 9/1/10A
RECALLING FIRM/MANUFACTURER
Dawn's Foods, Inc., Portage, WI, by letter dated June 24, 2010. Firm initiated recall is ongoing. 
REASON
This recall has been imitated due to the miss labeling in the ingredient statement. There is an undeclared allergen (shellfish) in the Delux Seafood Salad and an undeclared allergen(wheat) in the Vidalia Onion Dip.
VOLUME OF PRODUCT IN COMMERCE
70 cases (6/case or 420 containers 11oz & 14 oz) & 127 cases (2/case or 254 containers 5lbs).
DISTRIBUTION
IA, WI

_________________________________
PRODUCT
Giant Eagle Market District Couscous, Coarse Ground Semolina, Product of Israel, Net Wt. 23 oz, UPC 0 30034 00014 1. Packaged 12 / 23oz plastic jugs per case. Recall # F-2665-2010
CODE
SEP10, NOV10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trinidad Benham Corp., Denver, CO, by telephone and email on August 2, 2010. Firm initiated recall is ongoing.
Manufacturer: Indian Harvest Specialtifoods, Colusa, CA. Firm initiated recall is ongoing.
REASON
Ingredient label affixed to Couscous product was for an Arborio Rice product and did not declare wheat.
VOLUME OF PRODUCT IN COMMERCE
240 cases (2880 units)
DISTRIBUTION
IL, OH, PA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
______________________________________
PRODUCT
LORAZEPAM Injection, USP 2 mg/mL. 10 - 1mL vials, Rx only, For IM or IV use, NDC 0409-6778-02. Recall # D-769-2010
CODE
Lot Number: 88643EV01
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen, Chesterbrook, PA, by letter and follow up telephone on July 7, 2010.
Manufacturer: Hospira Inc., Lake Forest, IL. Firm initiated recall is ongoing.
REASON
Temperature Deviation; product had not been stored according to manufacturer's labeled temperature requirements prior to distribution.
VOLUME OF PRODUCT IN COMMERCE
163 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Kit for the Preparation of Technetium Tc99m Pentetate Injection (DTPA), 10 mL vial, a) 5 vial kits (NDC 45567-0010-1), b) 30 vial kits (NDC 45567-0010-2), Rx only. Recall # D-770-2010
CODE
Lot #s: 2414, Exp. Sept 30, 2010; 2416 Exp. June 30, 2011
RECALLING FIRM/MANUFACTURER
Pharmalucence, Inc., Bedford, MA, by email and letters on August 5, 2010. Firm initiated recall is ongoing. 
REASON
Product Lacks Stability: Technetium Tc99m Pentetate Injection does not maintain 90% Radiochemical Purity (RCP) for up to six hours after reconstitution with up to 160 mCi of Technetium Tc99m.
VOLUME OF PRODUCT IN COMMERCE
15,595 vials
DISTRIBUTION
Nationwide, Costa Rica, Bermuda, Israel, Republic of Panama
______________________________________
PRODUCT
ALTACE (ramipril) capsules, 2.5 mg, 100-count bottle, Rx only; NDC 61570-111-01. Recall # D-771-2010
CODE
Lot Number 57425, Exp 10/12
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals Inc., Bristol, TN, by letter dated August 2, 2010. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient Drug): This product is being recalled because stability samples found that it was subpotent at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE
16,382 bottles
DISTRIBUTION
Nationwide
______________________________________
PRODUCT
1) Triple Antibiotic (Polymyxin B Sulfates, Bacitracin Zinc, Neomycin, Pramoxine HCl) Ointment, Maximum Strength, Net Wt 0.5 oz. (14 gm), OTC, 1), NDC 11917-0823-34, UPC 3 11917 09750 3; 2) UPC 0 84579 10078 1. Recall # D-772-2010;

2) Triple Antibiotic (Polymyxin B Sulfates, Bacitracin Zinc, Neomycin, Pramoxine HCl) Ointment, Maximum Strength, Net 1 oz. (28 gm), OTC, NDC 11917-0823-56, UPC 3 11917 09749 7. Recall # D-773-2010
CODE
1) Lot Number: L909067, Exp: 09/11; L909055, Exp: 09/11;
2) Lot Number: L909066, Exp: 09/11
RECALLING FIRM/MANUFACTURER
Actavis Mid Atlantic LLC, Lincolnton, NC, by letter on/about July 22, 2010. Firm initiated recall is ongoing.
REASON
Degradation failure: 6 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
165,600 tubes
DISTRIBUTION
Nationwide
_________________________________
PRODUCT
Cephalexin for Oral Suspension, USP, 125 mg/5 mL, 100 mL bottle, Rx only, NDC 0093-4175-73. Recall # D-774-2010
CODE
Lot # 30301221A, Exp 3/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 10, 2010. 
Manufacturer: TEVA Pharmaceuticals USA, Inc., Fairfield, NJ. Firm initiated recall is ongoing. 
REASON
Subpotent (single ingredient) Drug: The product was found to be subpotent at the 12 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
12,776 bottles
DISTRIBUTION
Nationwide
______________________________________
PRODUCT
Hylenex recombinant (Hyaluronidase Human) Injection, 150 USP units/mL, Single Dose Vial, Rx Only, 1) NDC 60977-319-03, 2) NDC 60977-319-99. Recall # D-775-2010
CODE
Lot Numbers: 909775, Exp: 08/2010; 909777, Exp: 08/2010; 909779, Exp: 08/2010; 911728, Exp: 04/2011; 912462, Exp: 07/2011; 912916, Exp: 08/2011
RECALLING FIRM/MANUFACTURER
Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN, by press release on May 24, 2010. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance: The affected lots were found to contain small, flake-like glass particles.
VOLUME OF PRODUCT IN COMMERCE
34,032 vials
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
1) Children's ZYRTEC (Cetirizine HCl) Oral Solution, 5 mg, 4 OZ Bottle, Dye-Free Su gar-Free, Grape Syrup, OTC, UPC Code 3 0045-0209-047. Recall # D-776-2010;

2) Children's TYLENOL (Acetaminophen) Oral Suspension, 160 mg, 4 oz Bottle, Dye-Free, Cherry Flavor, OTC, UPC Code 3 0045-0166-043. Recall # D-777-2010;

3) Children's TYLENOL (Acetaminophen) Oral Suspension, 160 mg, 4 oz Bottle, Dye-Free, Grape SPLASH Flavor, OTC, UPC Code 3-0045-0296-047. Recall # D-778-2010;

4) Children's TYLENOL Plus COLD & STUFFY NOSE (Acetaminophen and Phenylephrine HCl), Oral Suspension, 160 mg and 2.5 mg, 4 oz Bottle, Dye-Free, Grape Flavor, OTC, Code 3 0045-0253-040. Recall # D-779-2010;

5) Children's TYLENOL Plus Multi-Symptom COLD (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, 4 oz Bottle, Dye-Free, Cherry Flavor, OTC, UPC Code 3 0045-0255-044. Recall # D-780-2010;

6) Children's TYLENOL Plus FLU (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz Bottle, Bubble Gum Flavor, OTC, UPC Code 3 0045-0386-052. Recall # D-781-2010;

7) Children's TYLENOL Plus COLD (Acetaminophen, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz Bottle, Grape Flavor, OTC, UPC Code 3 0045-0387-059. Recall # D-782-2010;

8) Children's TYLENOL Plus COLD & ALLERGY(Acetaminophen, Diphenhydramine HCl, and Phenylephrine HCl), Oral Suspension, 160 mg, 12.5 mg, and 2.5 mg, Oral Suspension, 4 oz Bottle, Bubble GUM Flavor, OTC, UPC Code 3 0045-0390-059. Recall # D-783-2010

9) Children's TYLENOL Plus Multi-Symptom COLD (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz, Grape Flavor, OTC, UPC Code 3 0045-. Recall # D-784-2010
CODE
1) Lot numbers: ASM308, ASM388, and ASM433;

2) Lot numbers: ALM336, ALM404, AMM312, ASM317, ASM328, and ASM396;

3) Lot numbers: ALM302, ALM351, ALM411, ALM412, AMM346, ASM315, ASM316, and ASM329;

4) Lot number: ALM409;

5) Lot numbers: ALM353, AMM309, AMM344, and ASM392;

6) Lot numbers: AJM405, AJM417, ALM306, ALM315, ALM339, ALM340, AMM313, AMM347, APM401, APM402, and APM403;

7) Lot numbers: ALM335, ASM369, and ASM395;

8) Lot number: AHM453;

9) Lot numbers: ALM303, ALM304, ALM305, ALM354, ALM356, ALM410, ALM419, ALM420, APM406, APM407, ASM307, and ASM340
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letters on March 29, 2010. Firm initiated recall is ongoing.
REASON
Defective Container: some products have thin walled bottles defect.
VOLUME OF PRODUCT IN COMMERCE
4,591,584 bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Prilosec Omeprazole Delayed Release Capsules, USP 20mg, 100UD NDC #68084-128-01, Dose NDC #68084-128-11. Recall # D-785-2010
CODE
Lot #, 083321, Exp. Date, 06/2010; Lot #, 083150, Exp. Date, 12/2010; Lot #, 083150A, Exp. Date, 01/2011; Lot # 083132, Exp. Date, 06/2010; Lot # 093318, Exp. Date 02/2011; Lot # 092327, Exp. Date 01/2011; Lot # 091476, Exp. Date 11/2010; & Lot # 090656, Exp. Date 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letter on July 16, 2010.
Manufacturer: Apotex Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.
REASON
GMP Deviations (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
52,791 units/100/20 mg capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) PEPCID Complete (Famotidine, Calcium Carbonate, Magnesium Hydroxide) Tablet, 10 mg, 800 mg, 165 mg; 50 Tropical Fruit flavor Chewable Tablets, Bottle, OTC; NDC 16837-246-50. Recall # D-787-2010;

2) PEPCID AC (Famotidine) Tablets, 10 mg, 90 Count Bottle, OTC, NDC 16837-872-90. Recall # D-788-2010
CODE
1) Lot Number: BEF062, Exp: May 2013;
2) Lot Number: BFF010, Exp: November 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Merck, Ft Washington, PA, by letters on August 3, 2010. 
Manufacturier: Mcneil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Defective Container: small number of bottles have been punctured at the bottom edge during the packaging process.
VOLUME OF PRODUCT IN COMMERCE
Pepcid Complete 15,264 bottles; Pepcid AC 360 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
______________________________________
PRODUCT
Source Plasma. Recall # B-2042-10
CODE
Units: 0140013769, 0140013912, 0140014133, 0140014389, 0140016295, 0140016392, 0140017155, 0140017615, 0140018074, 0140018220
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Los Angeles, CA, by facsimile on July 1, 2009. 
Manufacturer: Biomat USA, Inc., Fort Smith, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing and tattoo within 12
months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Spain
______________________________________
PRODUCT
Source Plasma. Recall # B-2045-10
CODE
Units: 06SWIG1280, 06SWIG0699, 06SWIF8355, 06SWIF7642, 06SWIG2241, 06SWIF9846, 06SWIF9006
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on March 5, 2007.
Manufacturer: BioLife Plasma Services LLC, Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Austria
_______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2046-10
CODE
Units: 302683420 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on February 28, 2008.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2047-10
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2048-10
CODE
1) W04240800963800C, W04240800964500E, W04240800964400G, W04240800965400C, W04240800962800G, W04240800965300E, W04240800962600K, W04240800964300I, W04240800962500M, W04240800963600G, W04240800963100Q, W04240800962400O, W04240800962200S, W04240800963000S, W04240800967700Z, W042408009674004, W042408009668000, W042408009667002, W042408009656008, W04240800966900Z, W04240800965100I, W04240800966000G, W042408009657006, W04240800967100A, W042408009648008, W04240800969700R, W04240800969500V, W042408009692000, W042408009683002, W042408009682004, W042408009690004, W04240800971700E, W04240800972600C, W04240800970900E, W04240800971200O, W04240800972200K, W04240800970800G, W04240800971000S, W04240800970700I, W04240800971900A, W04240800970500M, W04240800971800C, W04240800970100U, W04240800970300Q, W04240800968900R, W04240800969900N, W04240800969800P, W04240800974900Z, W042408009755002, W04240800973100I, W042408009756000, W04240800973000K, W042408009738004, W042408009753006, W042408009747002, W042408009752008, W042408009745006, W04240800974100E, W04240800973400C, W04240800973300E, W042408009748000, W042408009754004, W04240800973500A, W04240800978500R, W04240801040400C, W04240800978400T, W04240801040300E, W042408010417002, W04240800976500Z, W04240800978300V, W04240800979300R, W042408009763002, W04240800977500V, W04240800978200X, W04240801040100I, W042408009762004, W04240800977400X, W04240800977300Z, W04240800978100Z, W042408009772000, W042408009780000, W042408009771002, W042408009770004, W04240800976700V, W042408010426000, W042408010416004, W042408010425002, W042408010415006, W042408010423006, W04240801041300A, W04240800979200T, W042408010418000, W04240801042100A, W042408010434000, W04240801047400L, W04240801047100R, W04240801047000T, W04240801046700J, W04240801044700R, W04240801045800L, W04240801044300Z, W04240801046400P, W04240801043900R, W04240801046100V, W04240801047300N, W04240801045500R, W04240801047200P, W04240801045200X, W04240801045900J, W04240801043600X, W042408010450000, W04240801043500Z, W04240801044900N, W04240801045600P, W04240801052400X, W04240801052300Z, W042408010521002, W04240801052600T, W042408010520004, W04240801051600X, W04240801049500B, W042408010504004, W042408010514000, W04240801051700V, W04240801049300F, W042408010503006, W042408010512004, W04240801049200H, W042408010502008, W04240801048700B, W04240801050000C, W042408010510008, W04240801048600D, W042408010497007, W04240801050800X, W042408010496009, W04240801049000L, W042408010489007, W04240801053100Z, W042408010530000, W04240801052800P, W04240801053700N, W04240801054100V, W04240801055200P, W04240801056300J, W04240801083100B, W04240801054000X, W04240801055100R, W04240801082900*, W04240801083700*, W04240801053400T, W04240801053900J, W04240801055000T, W042408010836001, W04240801053600P, W042408010835003, W04240801053300V, W04240801081300F, W042408010827003, W042408010833007, W042408010596001, W04240801053500R, W042408010818005, W042408010832009, W042408010595003, W04240801081100J, W042408010594005, W04240801081500B, W042408010817007, W04240801082200D, W042408010592009, W04240801080700B, W042408010816009, W04240801080500F, W04240801081400D, W042408010584009, W04240801059100B, W04240801080200L, W04240801057400D, W04240801058300B, W04240801059000D, W04240801056100N, W04240801057300F, W04240801058900*, W04240801059700*, W04240801054900F, W04240801056000P, W04240801057100J, W042408010579003, W042408010587003, W04240801054800H, W04240801055900B, W04240801054400P, W04240801055700F, W04240801056600D, W042408010578005, W04240801055600H, W04240801056400H, W042408010576009, W04240801083800Y, W04240801053800L, W04240801054300R, W04240801055500J, W04240801087300S, W04240801088300O, W04240801088200Q, W04240801086900K, W04240801087200U, W04240801085700S, W04240801086800M, W04240801088100S, W04240801086400U, W04240801087100W, W04240801084500*, W04240801085600U, W04240801087900G, W042408010844001, W04240801085500W, W04240801086200Y, W04240801087800I, W042408010843003, W04240801087000Y, W042408010840009, W04240801085400Y, W04240801086100*, W04240801085300*, W042408010860001, W042408010852001, W04240801085800Q, W04240801084700W, W042408010923003, W042408010931003, W04240801093600U, W04240801089700C, W04240801093400Y, W04240801089500G, W042408010912009, W042408010930005, W04240801089400I, W04240801091100B, W04240801092900S, W04240801091000D, W042408010921007, W04240801092700W, W042408010908001, W04240801091900W, W04240801088600I, W042408010904009, W04240801090300B, W04240801088500K, W04240801092500*, W04240801093300*, W04240801091800Y, W042408010924001, W042408010932001, W042408010940001, W04240801089800A, W04240801099100G, W04240801096700G, W04240801099000I, W04240801097500G, W04240801097300K, W04240801094100*, W04240801095800I, W04240801097100O, W04240801098100K, W04240801095700K, W04240801097000Q, W04240801098000M, W04240801094600Q, W04240801095500O, W04240801096900C, W04240801095400Q, W04240801094400U, W04240801095300S, W04240801097600E, W042408010987008, W04240801095100W, W04240801096100S, W04240801098400E, W04240801094900K, W04240801097200M, W04240801098300G, W04240801094800M, W042408010943W, W04240801094200Y, W04240801142200T, W042408010997004, W04240801144600D, W04240801144300J, W04240801143700F, W04240801143600H, W04240801144100N, W04240801142100V, W04240801143900B, W04240801141900J, W04240801143200P, W04240801140900N, W04240801142700J, W042408011401002, W04240801140800P, W04240801142600L, W042408011492001, W042408011490005, W04240801149300*, W04240801148900S, W04240801146300B, W04240801147900W, W04240801148800U, W04240801145000L, W04240801147700*, W04240801148600Y, W042408011473007, W042408011483003, W042408011481007, W042408011458005, W04240801146900*, W042408011457007, W042408011466005, W04240801145400D, W04240801145200H, W04240801149700S, W04240801150700J, W04240801152000P, W04240801149600U, W04240801150600L, W04240801151100R, W04240801150400P, W04240801150200T, W04240801153000L, W042408011528009, W042408011538005, W04240801151700F, W04240801153400D, W04240801150800H, W04240801152400H, W04240801153300F, W04240801149800Q, W04240801151600H, W04240801156500*, W042408011560009, W04240801157400Y, W042408011548001, W04240801155800Y, W042408011547003, W042408011545007, W04240801154200D, W042408011555003, W04240801154900*, W042408011552009, W04240801155000D, W04240801156700W, W04240801182400U, W042408011804001, W04240801180800U, W04240801158600Q, W04240801184100S

2) Unit: W04240800968800T
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone from July 24, 2008 to July 28, 2008. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but may have had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
358 units
DISTRIBUTION
PA, WY, SD, AL, TX, NM, MS, LA, NV, NE, NH, Austria

______________________________________
PRODUCT
Source Plasma. Recall # B-2049-10
CODE
Units: 06SMNB1936, 06SMNB1133
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on July 13, 2007.
Manufacturer: BioLife Plasma Services, L.P., Saint Cloud, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
_____________________________________
PRODUCT
Source Plasma. Recall # B-2051-10
CODE
Units: TQ059645, TQ058983, TQ058656, TQ058176, TQ057511, TQ057246, TQ056795, TQ056323, TQ055906, TQ055554, TQ055081, TQ054702, TQ053789, TQ053460, TQ052690, TQ051964, TQ051292, TQ050886, TQ050350, TQ049904, TQ049468, TQ049048, TQ048625, TQ048200, TQ047967, TQ046876, TQ046313, TQ046113
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by fax on January 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
NC
______________________________________
PRODUCT
Platelets Pheresis 7d Leukocytes Reduced 200mL containing approx 30mL ACD-A. Store at 20-24 degrees C. Volunteer Donor. Recall # B-2055-10
CODE
Units: 9922911 Part 1; 9922911 part 2
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 16, 2008 and follow-up letter on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2067-10
CODE
Unit: W038110013776
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter dated March 5, 2010.
Manufacturer: Florida's Blood Centers, Inc., Lake Mary, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-2068-10
CODE
Unit: W286810018679; W286810018679 (double unit)
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on March 26, 2010. Firm initiated recall is complete.
REASON
Blood products, with post leukoreduction product recovery below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2069-10
CODE
Unit: W038110015617; W038109009849; 9581167
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Lake Park, FL, by letter dated March 5, 2010.
Manufacturer: Florida's Blood Centers, Jupiter, FL. 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
3 units
DISTRIBUTION
FL
______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced.  Recall # B-2070-10
CODE
Units: W090710004694; W090710004694 (split product)
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by fax on April 22, 2010 and May 18, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
CA
_______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2071-10
CODE
Unit: 72N605126
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on May 4, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2072-10
CODE
Unit: 72N73761X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on May 10, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
_______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2073-10
CODE
Unit: 72N493394
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on May 13, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2075-10
CODE
Unit: W115909235314
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on May 12, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2076-10
CODE
Units: 0042419 (Parts A & B), 0042253 (Parts A & B), 0042193 (Parts A & B), 0041093 (Parts A & B), 0040918 (Parts A & B), 0040527 (Parts A & B), 0040382 (Parts A & B), 0035014 (Parts A & B), 0043263 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated February 4, 2008, February 5, 2008, or February 13, 2008, and by facsimile on February 4, 2008. Firm initiated recall is complete.
REASON
Blood products, which may have had an elevated White Blood Cell (WBC) count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
MI, OH, WI, NC, AL
______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2078-10
CODE
Unit: 302681935
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter dated September 11, 2008.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SD

_______________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2079-10;
2) Red Blood Cells. Recall # B-2080-10;
3) Platelets. Recall # B-2081-10;
4) Fresh Frozen Plasma. Recall # B-2082-10
CODE
1) Units: 0977700, 0942907, 0920187;
2) Units: 1048562, 1016780, 0881764, 0866023, 0844936, 0830058, 0810960, 0760076, 0743819;
3) Unit: 1016780;
4) Units: 0881764, 0866023, 0830058, 0810960
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 17, 2008 or by electronic notification on January 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units  
DISTRIBUTION
MN, FL, NY, Switzerland
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2084-10
CODE
Unit: 5042782
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on January 29, 2008 and by letter dated January 29, 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
WI
_______________________________________
PRODUCT
Plasma Frozen. Recall # B-2085-10
CODE
Units: W04250802375800Y, W042508023770005, W04250802377700S, W042508023780001, W04250802378600Q, W04250802379900G, W04250802580500K, W04250802580700G, W042508026064009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on August 20, 2008.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
ND, SD
_______________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2087-10
CODE
Units: 24FR00067 (Bags 1 & 2), 24FR00097 (Bags 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by telephone on May 30, 2006 and by letter dated June 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using an apheresis machine that was not validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2089-10
CODE
Unit: 24FW30228
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter and electronic notification on April 22, 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
KY, CA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2090-10
CODE
Unit: 24FK09805
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter dated March 22, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was overweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
_______________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-2092-10
CODE
Unit: W001607703507
RECALLING FIRM/MANUFACTURER
Department of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH, by letter dated May 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-2093-10
CODE
Unit: 16GK16813
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on April 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner which may have compromised the sterility of the closed system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-2098-10
CODE
Unit: 16KS09772
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on November 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________________
PRODUCT
Platelets Pheresis 7d Leukocytes Reduced 200ml containing approx. 30 ml ACD-A. Store at 20 to 24 degrees C. Volunteer Donor. Recall # B-2100-10
CODE
Units: 9922558 Part A; 9922558 Part B
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 16, 2008 and by letter on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2101-10
CODE
Unit: 6112873
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on April 11, 2008. 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
TX
_______________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2102-10;
2) Cryoprecipitated AHF. Recall # B-2103-10
CODE
1) and 2) Unit: 24KE69129
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter on August 29, 2007. 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
OH

_______________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2104-10
CODE
Units: 1584299; 1584299; 1584396; 1584396; 1584353; 1584312; 1584312
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on March 6, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN, WI
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2105-10
CODE
Unit: 032GC56630
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on February 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
_______________________________________
PRODUCT
Red Blood Cells Leukocyte Reduced. Recall # B-2106-10
CODE
Unit: 5788043
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on June 13, 2008 and by fax on June 17, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested repeat reactive for the hepatitis C virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2107-10
CODE
Units: 6164406; 6150765
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on August 20, 2008 and follow up letters dated September 22, 2008 and October 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, Austria
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2109-10
CODE
Unit: 6163314
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on August 8, 2008. 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
TX
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2110-10
CODE
Unit: 53FW53948
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on November 16, 2007 and a follow-up letter on November 26, 2007. Firm initiated recall is complete.
REASON
Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
_______________________________________
PRODUCT
Source Plasma. Recall # B-2115-10
CODE
Units: 4020270413, 4020268673, 4020265259
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Akron, OH, through online communication on February 12, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Germany
_______________________________________
PRODUCT
Source Plasma. Recall # B-2116-10
CODE
Units: 0530547822, 0530523901, 0530519386, 0530511263, 0530510665, 0530510405, 0530508796, 0530508116, 0530507392, 0530505814, 0530493449, 0530478021, 0530473907, 0530463164, 0530461545, 0530454615, 0530454092, 0530453621
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Lexington, KY, through online communication and facsimile transmissions dated February 10, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
IL, Germany and Switzerland
_______________________________________
PRODUCT
Source Plasma. Recall # B-2117-10
CODE
Units: 12521494, 12517800, 12514823, 12508242, 12506163, 12502325, 12487158, 12483563, 12479474
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., San Antonio, TX, by facsimile transmission dated February 10, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
_______________________________________
PRODUCT
Source Plasma. Recall # B-2118-10
CODE
Units: 0141306501, 0141306128, 0141305474, 0141305165, 0141304354, 0141299445, 0141296610, 0141296334, 0141295618, 0141294743, 0141294344, 0141287032, 0141286698, 0141285800, 0141285669, 0141159165, 0141158033, 0141157093, 0141156760, 0141156080, 0141155209, 0141151547, 0141150786, 0141148736, 0141148461, 0141167237, 0141166753, 67 FTHPFD, 67 FTHNZL, 67 FTHXRY, 67 FTHMKW, 67 FTHMCV, 67 FTHLQP, 67 FTHLJP, 67 FTHKVW, 67 FTHKQB, 67 FTHJYR, 67 FTHJMY, 67 FTHJGR, 67 FTHHLJ, 67 FTHHDQ, 67 FTHYNC, 67 FTHXYF, 67 FTHWMV, 67 FTHNGB, 67 FTHMZC, 67 FTHMPY, 67 FTGGDM, 67 FTGFZX, 67 FTGFVH, 67 FTGFKT, 67 FTFYQL, 67 FTFYMS, 67 FTFYHF, 67 FTFYDT, 67 FTFSVK, 67 FTFSSM, 67 FTFSMJ, 67 FTFSLC, 67 FTFSDS, 67 FTFSBC, 67 FTFRXB, 67 FTFRVC, 67 FTFRMW, 67 FTFRKD, 67 FTFRCY, 67 FTFQZN, 67 FTFLGT, 67 FTFLDY, 67 FTFCTD, 67 FTDWZH, 67 FTDWVY, 67 FTDWDD, 67 FTDVZB, 67 FTDVTH, 67 FTDVQL, 67 FTDVKY, 67 FTDVGX, 67 FTDVBB, 67 FTDTWW, 67 FTDRKN, 67 FTDRGW, 67 FTDRCT, 67 FTDQYS, 67 FTDQTZ, 67 FTDQRL, 67 FTDPTG, 67 FTDPLK, 67 FTDPJM, 67 FTDJLZ, 67 FTDJKK, 67 FTDHYF, 67 FTDHWD, 67 FTDHQQ, 67 FTDHMW, 67 FTDHHV, 67 FTDHFY, 67 FTDGXV, 67 FTDGVS, 0141110678, 0141186804, 0141186368
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Tulsa, OK, through online communication or facsimile transmissions dated February 11, March 4, April 7 and 13, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
102 units
DISTRIBUTION
NC, IL, Switzerland, Germany
_______________________________________
PRODUCT
Source Plasma. Recall # B-2119-10
CODE
Units: 7010243541, 7010242401, 7010240904, 7010238028, 7010237546, 7010236767, 7010236522, 7010235880, 7010235583, 7010231900, 7010231371, 7010223760, 7010223522, 7010222703
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Lawton, OK, by facsimile transmission dated February 12, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-2066-10
CODE
Unit: W04200901793500
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette, LA, via the SPI system on April 21, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2074-10
CODE
Units: 72N305062; 72N320993
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Mobile, AL, by fax on May 10, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2077-10
CODE
Unit: W053308800699
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on May 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was below the acceptable limit for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-2083-10
CODE
Units: 1045862, 1016780, 0977700, 0942907, 0920187, 0895985, 0844936, 0760076, 0743819
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 17, 2008 or by electronic notification on January 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MN, FL, NY, Switzerland
_______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2086-10
CODE
Unit: 24FY13055
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by telephone on February 18, 2008 and by letter dated February 18, 2008. Firm initiated recall is complete.
REASON
Blood product which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-2088-10
CODE
Unit: 24FW30228
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter and electronic notification on April 22, 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
KY, CA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2091-10
CODE
Units: 53GJ72007; 53GJ71986; 53GJ71996; 53GJ71993; 53GJ72010; 53GJ71997; 53GJ71990; 53GJ71984; 53GJ71981
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD,      by telephone or electronic mail on October 16, 2007 and a follow-up letter dated October 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using scales for which the daily quality control testing was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MD, DC.
_______________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2094-10;
2) Red Blood Cells. Recall # B-2095-10;
3) Recovered Plasma. Recall B-2096-10;
4) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2097-10
CODE
1) Unit: 1661965;
2) Unit: 1665875;
3) Units: 1663821, 1664831;
4) Unit: 1669819 Part 1
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on October 23, 2008. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MN, NJ
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. B-2099-10
CODE
Units: 032FT17791; 032FT17792; 032FT17793; 032FT17794; 032FT17795; 032FT17796; 032FT17797; 032FT17798; 032FT17799; 032FT17800; 032FT17802; 032FT17803; 032FT17804; 032FT17805; 032FT17806; 032FT17807; 032FT17809; 032KR55399; 032KR55400; 032KR55401; 032KR55402; 032KR55403; 032KR55404; 032KR55405; 032KR55406; 032KR55407; 032KR55408; 032KR55409; 032KR55410; 032KR55412; 032KR55413; 032KR55414; 032KR55416; 032KR55419; 032KR55420; 032KR55422; 032KR55423; 032KR55424; 032KR55425; 032KR55426; 032KR55427; 032KR55428; 032KR55429; 032KR55430; 032KR55432; 032KR55433; 032KR55435; 032KR55437; 032KR55438; 032KR55439; 032KR55440; 032KR55443; 032KR55444; 032KZ03491; 032KZ03494; 032KZ03495; 032KZ03502; 032KZ03503; 032KZ03504; 032KZ03505; 032KZ03506; 032KZ03507; 032KZ03509; 032KZ03510; 032KZ03565; 032KZ03566; 032KZ03567; 032KZ03568; 032KZ03569; 032KZ03570; 032KZ03575; 032KZ03576; 032KZ03577; 032KZ03583; 032KZ03584; 032KZ03585; 032KZ03590; 032KZ03591; 032KZ03593; 032KZ03595; 032KZ03596; 032KZ03597
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on September 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using equipment for which quality control was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
MA, IL, PA, WI, ME
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-2108-10
CODE
Units: 6164406; 6150765
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on August 20, 2008 and follow up letters dated September 22, 2008 and October 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, Austria

______________________________________
PRODUCT
Micro SSP Allele Specific HLA Class I DNA Typing Tray-B*35. Recall # B-2165-10
CODE
Lot 002, batch 025
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA, by letter dated May 3, 2010. Firm initiated recall is ongoing.
REASON
Micro SSP Allele Specific HLA Class I DNA Typing Tray-B*35, which may potentially cause false negative reactions for rare B*35 alleles, was distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MI, IL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
______________________________________
PRODUCT
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-2100-2010
CODE
Lot: LU8QJ000
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated June 30, 2010.
Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing.
REASON
Monitor fell from the mounting bracket used to support the monitor
VOLUME OF PRODUCT IN COMMERCE
805 units
DISTRIBUTION
Nationwide and Canada
______________________________________
PRODUCT
1) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2101-2010;

2) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2102-2010;

3) Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2103-2010;

4) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2104-2010;

5) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2105-2010

6) Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2106-2010
CODE
1) Lot Number K131823;
2) Lot Number K131824;
3) Lot Number K131832;
4) Lot Number K130761 (3 year expiry), P116003 (1 year expiry);
5) Lot Number K131835;
6) Lot Number K131837
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by e-mail on June 28, 2010. 
Manufacturer: Merit Medical Ireland Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
VOLUME OF PRODUCT IN COMMERCE
964 units
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes. Recall # Z-2110-2010
CODE
Test kit lot numbers: H9KHR002, Exp 07/2010 and BOKHR001, Exp 1/2011; RAF 10-016
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letters dated June 24, 2010. Firm initiated recall is ongoing.
REASON
An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.
VOLUME OF PRODUCT IN COMMERCE
Lot B0KHR001: 13 in US, 3 out of US, Lot H9KHR002: 25 in US
DISTRIBUTION
CA, NC, TX, FL, MD, OK, NY, NJ and Italy
_____________________________________
PRODUCT
Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; Made in Dominican Republic; REF CCH2220 For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone. Recall # Z-2111-2010
CODE
Lot D09121745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 2200 Inc., Waukegan, IL, by telephone and letter on June 15, 2010.
Manufacturer: Cardinal Health, Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON
The introducer needle is only 10 cm in length instead of the required 15 cm.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
CA, FL, GA, IL, KY, MA, NJ, NY, PA
______________________________________
PRODUCT
International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test curettes’ on the Hemochron Microcoagulation Systems. Recall # Z-2200-2010
CODE
Lot number: M9DNL055, exp. 9/2010
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letters on June 25, 2010. Firm initiated recall is ongoing.
REASON
The package insert for the direct Check Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR curettes’.
VOLUME OF PRODUCT IN COMMERCE
122 boxes in US, 1 box out of US. Each box contains 15 vials
DISTRIBUTION
Nationwide and Belgium
______________________________________
PRODUCT
1) Philips Intellivue Patient Monitor Model MP60 (M8005A). Recall # Z-2201-2010;

2) Philips Intellivue Patient Monitor Model MP70 (M8007A). Recall # Z-2202-2010
CODE
1) Serial Numbers: DE22701289 - DE843 16576;
2) Serial Numbers: DE22702728 - DE84399581
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, 
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.
REASON
Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
VOLUME OF PRODUCT IN COMMERCE
93, 548 units
DISTRIBUTION
Nationwide and Internationally
______________________________________
PRODUCT
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component. Recall # Z-2204-2010
CODE
Lot: M402080
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by telephone on April 13, 14 and 15, and by letter dated April 20, 2010. Firm initiated recall is ongoing.
REASON
A knee implant labeled as left was opened and the package actually contained a right knee implant.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IN and Japan
_______________________________________
PRODUCT
Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilator support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support. Recall # Z-2205-2010
CODE
Units: Y09D1922 Y09H0564 Y09H0565 Y09K0491 Y09K0492 Y09S1283 Y09S1284 Y10A1230
RECALLING FIRM/MANUFACTURER
Recalling Firm: CareFusion 203, Inc., Minneapolis, MN, by letter dated July 2, 1010. 
Manufacturer: Productos Urologos de Mexico S.A. de C.V., Mexicali, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both audible and visual alarm indicators to alert the Health Care Professional to provide alternative ventilation as required.
VOLUME OF PRODUCT IN COMMERCE
200 boxes (5 ea)
DISTRIBUTION
Nationwide
_____________________________________
PRODUCT
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically. Z-2209-2010
CODE
Lot Serial No IJX061043P IJX061063P IJX067150P IJX067158P IJX067162P IJX013664P IJX013831P IJX014701P IJX014899P IJX015305P IJX015406P IJX015768P IJX062594P IJX062607P IJX062654P IJX062655P IJX062656P IJX062661P IJX062669P IJX062670P IJX062672P IJX062673P IJX062674P IJX062683P IJX062698P IJX062701P IJX062706P IJX062716P IJX062727P IJX062734P IJX062736P IJX062738P IJX062739P IJX062741P IJX062747P IJX062763P IJX062764P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letters dated 6/10/2010. 
Manufacturer: Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall is ongoing.
REASON
Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Australia and Canada

______________________________________
PRODUCT
1) Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. Recall # Z-2214-2010;

2) Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. Recall # Z-2215-2010;

3) Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. Recall # Z-2216-2010;

4) Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile. Recall # Z-2217-2010;
CODE
1) Lots: 60492194, 60531068, 60530835, 60724676, 60680532, 60770940, 60796676, 60904592, 61195210, 61076505, 61424513 and 61424514;

2) Lots: 60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530;

3) Lots: 60492196, 60531086, 60703467, 60667441, 60728123, 60767106, 60787931, 60808260, 60904605, 61024439, 61143012, 61217116 and 61355988;

4) Lots: 60492197, 60704071, 60667465, 60728122, 60770944, 60796679, 60862513, 61081548, 61143008, and 61324533
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated 4/6/2010.  
Manufacturer: Zimmer Trabecular Metal Technology, Inc., Parsippany, NJ. Firm initiated recall is ongoing. 
REASON
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
VOLUME OF PRODUCT IN COMMERCE
1,972 units
DISTRIBUTION
Nationwide, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland

END OF ENFORCEMENT REPORT FOR AUGUST 25, 2010

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