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U.S. Department of Health and Human Services

Safety

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Enforcement Report for July 27, 2011

 

 
July 27, 2011                                                                                        11-30
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Let's Be Frank Hot Dog Seasoning; 8.46 lb Mylar bags packed 25 bags per one 35 gallon drum. Recall # F-1540-2011
CODE
Lot #: 1000142677
RECALLING FIRM/MANUFACTURER
ABCO Laboratories Inc., Fairfield, CA, by telephone on April 22, 2011. Firm initiated recall is complete.
REASON
Firm was notified by their supplier that organic coriander seed was being recalled due to potential salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
25 x 8.46 lb bags
DISTRIBUTION
CA
___________________________________
PRODUCT
Dole Italian Blend, 10 oz (283g) plastic bag. Ingredients: Romaine Lettuce, Radicchio. Dole Italian Blend: UPC 714300819, Product codes: 0049A157201A, 0049A157201B, 0049A157202A, 00491A57202B. 0686A157202A, 068A157202B. Also packaged as Dole Melange Italien (Canadian Distribution) and Kroger Fresh Selections Italian Style Blend, UPC 1111901045; Product codes: A157201A and A157201B. Recall #F-1541-2011
CODE
Use By Date of June 19, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dole Fresh Vegetables Inc., Monterey, CA, by telephone on June 21, 2011 and a Press Release was issued on June 22, 2011.
Manufacturer: Dole Fresh Vegetables Inc., Springfield, OH. Ohio initiated recall is ongoing.
REASON
Ohio State Department of Agriculture conducted random sampling and found Listeria monocytogenes in one sample of Dole Italian Blend bagged salad with use by date of Jun 19, 2011.
VOLUME OF PRODUCT IN COMMERCE
2880 cases of Dole Brand, 442 cases of Kroger Fresh Selections
DISTRIBUTION
IL, IN, KY, ME, MI, MS, NJ, NY, OH, PA, TN and WI
___________________________________
PRODUCT
1) Butter Mini Croissants, 12 oz, clear, plastic clamshell container, 12 croissants per container. Sold with the Whole Foods Label. UPC 21609300000. Recall # F-1542-2011;
 
2) Chocolate Mini Croissants, 12 oz, clear, plastic clamshell container, 12 croissants per container. Sold with the Whole Foods Label. UPC 21609400000. Recall # F-1543-2011
CODE
All expiration best-buy dates and lot codes prior to July 6, 2011.
RECALLING FIRM/MANUFACTURER
The Posh Bakery, Inc., Santa Clara, CA, by e-mail on July 6, 2011 and by press release on July 8, 2011. Firm initiated recall is ongoing.
REASON
Complaint received of an allergic reaction to mini croissants that have an egg wash applied but eggs are not declared in the ingredient labeling.
VOLUME OF PRODUCT IN COMMERCE
Approximately 100 packages of croissants a day
DISTRIBUTION
CA
___________________________________
PRODUCT
Lundberg Rice Chips (Croustilles De Riz), Sea Salt. Sel de Mer, 170 gr, 6 oz. UPC 0 73416 03540 9. Recall # F-1544-2011
CODE
Coded 11011, Best Before 2012 FE 13
FIRM/MANUFACTURER
Recalling Firm: Lundberg Family Farms, Richvale, CA, by press release, telephone or e-mail on June 24, 2011.
Manufacturer: Sherer's Food, Inc., Hermiston, OR. Firm initiated recall is ongoing.
REASON
Sea Salt Rice Chips contain soy that is not listed in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
423
DISTRIBUTION
Canada
___________________________________
PRODUCT
1) Risvold's Inc. Seafood Salad 5lbs. net wt. Recall # F-1545-2011;
2) Risvold's Inc. Seafood Pasta 5 lbs. net wt. Recall # F-1546-2011
CODE
1) Best By date: 062711, 070411, 071111;
2) Best By date: 071711
RECALLING FIRM/MANUFACTURER
Risvold's Inc., Gardena, CA, by letter on June 23, 2011, by telephone and letters on June 23, 2011. FDA initiated recall is ongoing.
REASON
The recall was initiated because the seafood salad and seafood pasta salad may contain undeclared milk, sunflower, sesame and soy.
VOLUME OF PRODUCT IN COMMERCE
116 cases
DISTRIBUTION
NV, OR, WA, MT, ID
___________________________________
PRODUCT
1) SOUTHERN HOME Whole Onion Rings 0g Trans Fat per serving NET WT 16 oz (1 lb) 454 g, UPC 6 0788001109 8 INGREDIENTS: ONIONS, BLEACHED WHEAT FLOUR, PARTIALLY HYDROGE-NATED SOYBEAN OIL, WATER, CONTAINS 2% OR LESS OF THE FOLLOWING: MODIFIED FOOD STARCH, SALT, SUGAR, YELLOW CORN FLOUR, YEAST, DRIED WHEY, ONION POWDER, YELLOW 5, YELLOW 6, LEAVENING (SODIUM ACID PYROPHOSPHATE, AND SODIUM BICARBONATE), GARLIC POWDER, SPICE. CONTAINS: MILK, WHEAT, AND SOY. Recall # F-1547-2011;
 
2) SOUTHERN HOME Diced Onion Rings 0g Trans Fat per serving NET WT 20 oz (1 lb 4 oz) 567g, UPC 6 0788001108 1 INGREDIENTS: DICED ONIONS, BLEACHED WHEAT FLOUR, SOYBEAN OIL, WATER, MODIFIED FOOD STARCH, WHEAT FLOUR, CONTAINS 2% OR LESS OF THE FOLLOWING: SUGAR, METHYL CELLULOSE, DEXTROSE, SODIUM ALGINATE, YELLOW CORN FLOUR, SALT, CALCIUM CHLORIDE, EXTRACTIVES OF PAPRIKA, NATURAL AND ARTIFICIAL FLAVOR, SODIUM TRIPOLYPHOSPHATE, SOY LECITHIN, YEAST, LEAVENING (SODIUM ACID PYRO PHOSPHATE, AND SODIUM BICARBONATE) CONTAINS: WHEAT, AND SOY. Recall # F-1548-2011;
 
3) Surfine Onion Rings Net Wt 16oz (1 lb) 454 g, UPC 0 1116113398 8, INGREDIENTS: DICED ONIONS, BLEACHED WHEAT FLOUR, SOYBEAN OIL, WATER, MODIFIED FOOD STARCH, WHEAT FLOUR, CONTAINS 2% OR LESS OF THE FOLLOWING: SUGAR, METHYL CELLULOSE, DEXTROSE, SODIUM ALGINATE, YELLOW CORN FLOUR, SALT, CALCIUM CHLORIDE, EXTRACTIVES OF PAPRIKA, NATURAL AND ARTIFICIAL FLAVOR, SODIUM TRIPOLYPHATE, SOY LECITHIN, YEAST, LEAVENING (SODIUM ACID PYRO PHOSPHATE, AND SODIUM BICARBONATE). CONTAINS: WHEAT AND SOY. Recall # F-1549-2011;
 
4) Food Club Onion Rings MADE FROM DICED ONIONS NET WT 16 oz (1 lb) 454g UPC 0 3680032216 5 INGREDIENTS: DICED ONIONS, BLEACHED WHEAT FLOUR, SOYBEAN OIL, WATER, MODIFIED FOOD STARCH, WHEAT FLOUR, CONTAINS 2% OR LESS OF THE FOLLOWING: SUGAR, METHYL CELLULOSE, DEXTROSE, SODIUM ALGINATE, YELLOW CORN FLOUR, SALT, CALCIUM CHLORIDE, EXTRACTIVES OF PAPRIKA, NATURAL AND ARTIFICIAL FLAVOR, SODIUM TRIPOLYPHOSPHATE, SOY LECITHIN, YEAST, LEAVENING (SODIUM ACID PYROPHOSPHATE, AND SODIUM BICARBONATE). CONTAINS: WHEAT, AND SOY. Recall # F-1550-2011;
 
5) Better Valu Breaded Onion Rings Net Wt 16 oz (1 lb) 454 g UPC 0 7980199545 7 INGREDIENTS: DICED ONION, BLEACHED WHEAT FLOUR, SOYBEAN OIL, WATER, MODIFIED FOOD STARCH, WHEAT FLOUR, CONTAINS 2% OR LESS OF THE FOLLOWING: SUGAR, METHYL CELLULOSE, DEXTROSE, SODIUM ALGINATE, YELLOW CORN FLOUR, SALT, CALCIUM CHLORIDE, EXTRACTIVES OF PAPRIKA, NATURAL AND ARTIFICIAL FLAVOR, SODIUM TRIPOLYPHOSPHATE, SOY LECITHIN, YEAST, LEAVENING (SODIUM ACID PYROPHOSPHATE, AND SODIUM BICARBONATE) ALLERGEN STATEMENT: CONTAINS WHEAT, AND SOY. Recall # F-1551-201;
 
6) BEST YET GOURMET ONION RINGS Made from Fresh Onions NET WT 16 oz (1 LB.) 454g UPC 0 4218700192 0 INGREDIENTS: ONIONS, BLEACHED WHEAT FLOUR, SOYBEAN OIL, WATER, CONTAINS 2% OR LESS OF THE FOLLOWING: MODIFIED FOOD STARCH, SALT, SUGAR, YELLOW CORN FLOUR, YEAST, DRIED WHEY, ONION POWDER, YELLOW 5, YELLOW 6, LEAVENING (SODIUM ACID PYROPHOSPHATE, AND SODIUM BICARBONATE), GARLIC POWDER, SPICE. CONTAINS: MILK, WHEAT, AND SOY. Recall # F-1552-2011
CODE
All lot codes sold prior to 05/27/11 are being recalled.
RECALLING FIRM/MANUFACTURER
Transpecos Foods, LP, Pecos, TX, by telephone on May 23, 2011 and issued a press release on May 26, 2011. Firm initiated recall is ongoing.
REASON
Products contain undeclared egg and/or milk.
VOLUME OF PRODUCT IN COMMERCE
24,770 cases
DISTRIBUTION
GA, IL, WI, and TX
___________________________________
PRODUCT
Archer Farms ground Turmeric, packaged in 2.6-oz. glass bottles, Product of India, Indonesia. Recall # F-1558-2011
CODE
Bottle lot numbers 1740901A, 2180902A, 2780906A, 2920903A, 3060903A, and 0071003A, with best by dates from 6/23/2011-1/7/2012.
RECALLING FIRM/MANUFACTURER
Brinkhoff & Monoson Inc., Mount Vernon MO, by telephone on April 8, 2011 and by press release on April 15, 2011. FDA initiated recall is complete.
REASON
The product may contain elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
7,397/2.6-oz. bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Food Club(R) Mexican Style Enchilada Sauce, Red, Net wt 10 oz (284g), UPC: 036800292208. Recall # F-1562-2011
CODE
ECH 451244, Best Before Date: 5/13/2015
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bruce Foods Corp., New Iberia, LA, by Press Release on July 13, 2011 and by letter on July 14, 2011.
Manufacturers: Bruce Foods Corp., New Iberia, LA;
Bruce Foods Corp., El Paso, TX. Firm initiated recall is ongoing.
REASON
Undeclared soy and wheat: One can of product labeled as containing red enchilada sauce, contained green enchilada sauce which contains wheat and soy.
VOLUME OF PRODUCT IN COMMERCE
699 cases of 12
DISTRIBUTION
TX, VA, MN, AL and OH
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Roadside Market Cherry Barbecue Sauce, RECIPE: Red & Black cherries, Tomato Paste, Vinegar, Brown Sugar, Salt, Spices, Garlic, Xanthan Gum, Pure Almond Extract, Net Wt. 16 oz. Recall # F-1553-2011
CODE
Unit: 07008
RECALLING FIRM/MANUFACTURER
Slack's, Inc., Lodi, WI, by telephone on May 25, 2011 and May 28, 2011. FDA initiated recall is ongoing.
REASON
Slack,s Inc. is recalling Roadside Market brand Cherry Barbecue Sauce because the firm failed to adequately document what ingredients (including allergens) were used in the manufacture of the product.
VOLUME OF PRODUCT IN COMMERCE
233 jars
DISTRIBUTION
WI, MN
___________________________________
PRODUCT
1) Maple Grove Farms Sugar Free Italian Balsamic Dressing Net 8. fl. oz. (237 mL) Item number 57201541 UPC 07468308547. Recall # F-1554-2011;
2) Maple Grove Farms Sugar Free Balsamic Dressing Net 8. fl. oz. (237 mL), Item number 57201544, UPC 074683008516. Recall # F-1555-2011
CODE
Best by date on or before February 28, 2013 All products have a 24 month shelf life.
RECALLING FIRM/MANUFACTURER
Recalling Firm B&G Foods, Inc., Parsippany, NJ, by telephone on February 15, 2011 and by letters on March 4, 2011.
Manufacturer: B & G Foods, Inc., Saint Johnsbury, VT. Florida initiated recall is complete.
REASON
Sugar-free salad dressing exceeds the amount of sugar per serving that is permitted for a sugar free claim.
VOLUME OF PRODUCT IN COMMERCE
44,435 cases (12 bottles per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Fresh’n Ready Oven Rising Sheeted Pizza Dough distributed under the following product codes, net weights and UPC #s: (1) Product Code 03604: Rich Products 16" Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 16.67 KG (36 lb 14 oz), UPC # 00 49800 03604 8; (2e Product Code 06642: Rich Products 10" Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie, Net Case Wt 17 KG (37lb 8 OZ), UPC # 0 00 49800 06642 7; (3) Product Code 07366: Rich Products 12" Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 11.2 KG (24 lb 14 oz), UPC # 0 00 49800 07366 1; (4) Product Code 07367: Rich Products 14" Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 12.8 KG (28 lb 6 oz), UPC # 0 00 49800 007367 8; (5) Product Code 07386: Rich Products 7" Fresh 'n Ready OVEN Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 13.4 KG (29 LB 11 oz), UPC # 0 00 49800 07386 9; (6) Product Code 08848: Fresh'n ready 12" x 15" Oven Rising Sheeted Pizza Dough, Net Case Wt 16.5 KG (36 lb 8 oz), UPC # 0 00 49800 08848 1 (dual language labeling - English & French). Product codes 03604, 06642, 07366, 07367, 07386 and 08848. Recall # F-1556-2011
 
2) Wheat Fresh 'n Ready Oven Rising Sheeted Pizza Dough distributed under the following product codes, net weights and UPC #s: (1) Product Code 07945: Rich Products 16" Wheat Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 16.7 kg (36 lb 14 oz), UPC # 0 00 49800 07945 8; (2) Product Code 08012: Rich Products 7" Wheat Fresh 'n Ready Oven Rising Sheeted Pizza Dough (Fort Erie), Net Case Wt 13.4 KG (29 lb 11 oz), UPC # 0 00 49800 08012 6. Product codes 07945 and 08012. Recall # F-1557-2011
CODE
Produced between April 29, 2011 (Julian Code 77001119) and June 10, 2011 (Julian Code 77001161)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo, NY, by letters dated June 22, 2011 followed up with telephone calls.
Manufacturer: Rich Products Of Canada Ltd, Fort Erie, Ontario, Canada. Firm initiated recall is ongoing.
REASON
The products have the potential to be contaminated with metal fragments from the soy flakes raw material.
VOLUME OF PRODUCT IN COMMERCE
USA: 9188 cases, Canada: 904 cases; Costa Rica: 4 cases
DISTRIBUTION
Nationwide, Canada, and Costa Rica
___________________________________
PRODUCT
1) Donia Sweet Donia Lokum traditional sweets Net. Wt.; 450 g/15.8 oz; UPC 5319990181893. Recall # F-1559-2011;
 
2) Donia Sweet Donia Lokum traditional sweets Lokum with walnuts Net. Wt.: 450 g/15.8 oz; UPC 5319990181879. Recall # F-1560-2011
CODE
1) EXP dates - 15.09.12; 01.02.2012;
2) EXP dates - 15.09.2011, 01.11.2011, 01.02.2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: European Natural Food & Trading Company Inc., Paterson, NJ, by telephone on April  26, 2011 and by letters on May 9, 2011.
Manufacturer: Donia DOO, Prilep, Macedonia. New York initiated recall is ongoing.
REASON
Lokum with Walnuts contain a non-permitted color, Ponceau 4R (E124) and undeclared FD&C Yellow No. 6 (E110 was listed instead).
VOLUME OF PRODUCT IN COMMERCE
98 cases (12 boxes each)
DISTRIBUTION
NJ, CT, CO, FL, MO, NY, PA, VA
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report7, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to RecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Nature's Partner Women's Balance, All Natural Paraben Free, 50 mL pump bottle; UPC Code 816726006017. Recall # D-711-2011
CODE
Lot # 050612
RECALLING FIRM/MANUFACTURER
Cosmed Labs Inc., Louisville, KY, by telephone on February 17, 2011. FDA initiated recall is ongoing.
REASON
Misbranded - Labeling bears unapproved therapeutic claims; During an FDA inspection, 2/03/2011 - 03/22/2011, the firm was notified that the product was misbranded due to "structure/function" claims made on the product label, making it an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
183 pump bottles
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Q-Tussin DM (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-0855-58; UPC 3 0603-0855-58 1. Recall # D-714-2011;
 
2) CODITUSS DM liquid (Dextromethorphan HBr, USP, 10 mg per 5 mL; Phenylephrine HCl, 5 mg per 5 mL; Pyrilamine Maleate, 8.33 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0728-54; UPC 3 0603-0728-54 0. Recall # D-715-2011;
 
3) Q-Tapp liquid (Brompheniramine maleate, USP, 1 mg per 5 mL; Dextromethorphan HBr, USP, 5 mg per 5 mL; Pseudoephedrine HCl, USP, 15 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0852-94; UPC 3 0603-0852-94 8. Recall # D-716-2011
 
4) Iophen DM-NR (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-1330-58; UPC 3 0603-1330-58 2. Recall # D-717-2011
CODE
1) Lot #: L145C10A, L028C10A; Exp 04/12;
2) Lot #: L089C10A, L089C10B, Exp 04/12;
3) Lot #: L090C10A, Exp 04/12;
4) Lot #: L099D10A, L107C10A, L115C10A, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by recall notifications, dated May 5, 2011.
Manufacturer: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL. Firm initiated recall is ongoing.
REASON
CGMP Deviations: These products have been manufactured with a lot of dextromethorphan which was found to be out of specification for an impurity.
VOLUME OF PRODUCT IN COMMERCE
103,718 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Povidone Iodine, USP Prep Solution, 10% Topical Solution, (equivalent to 1% titratable iodine), Antiseptic, First Aid Antiseptic, For Hospital and Professional Use, For external use only, Made in USA, Packaged under the following labels and sizes: (1) NOVAPLUS, a) 4 Fluid Ounces (118 mL), Cat No. V10-8204, NDC 50730-8204-9, b) 16 Fluid Ounces (473 mL), Cat No. V10-8216, NDC 50730-8216-9, c) 32 Fluid Ounces (946 mL), Cat No. V10-8232 NDC 50730-8232-9, d) 128 Fluid Ounces (3.79 L), Cat No. V10-8228, NDC 50730-8228-9; (2) Triadine, a) 4 Fluid Ounces (118 mL), Cat. No. 10-8204, NDC 50730-8204-3, b) 128 Fluid Ounces (3.785 L) Cat. No. 10-8228 / NDC 50730-8228-8; (3) Triad, Triadine Whirlpool Concentrate, Antispetic/Germicide, 128 Fluid Ounces (3.785 L), Cat No. 10-8428, NDC 50730-8428-6; (4) Triad, Plus, a) 2 Fluid Ounces (59 mL), Cat No. 11-LP02, NDC 50730-8202-2, b) 4 Fluid Ounces (118 mL), Cat No. 11-LP04, NDC 50730-8204-3; (5) PSS Select, 1 Gallon (3.785 L). Recall # D-718-2011
CODE
Lot #s: 0H04; 0H07; 0F19; 0K27; Exp 08/13
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by letter dated June 14 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: H & P initiated a recall of 4 lots of Povidone Iodine Solution as a result of stability results showing low active ingredient, Iodine.
VOLUME OF PRODUCT IN COMMERCE
104,280 bottles
DISTRIBUTION
Nationwide, PR, Lebanon, and Trinidad
___________________________________
PRODUCT
Torsemide tablets, 100 mg, 100-count bottle, Rx only, NDC 31722-532-01. Recall # D-721-2011
CODE
Batch # E100688; Exp 09/12
RECALLING FIRM/MANUFACTURER
Hetero Drugs Limited, Unit-III (Formulations), Hyderabad, IN, by letter dated May 12, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: One lot of torsemide 100 mg tablets 60-count bottle may contain torsemide 10 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
3,900 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
The Triad Povidone Iodine Prep Pads in the following Atwater Carey First Aid Kits are being recalled: Atwater Carey, First Aid Kit Personal, 158A, 3 68093 00158 9; Atwater Carey, First Aid Kit Dayhiker, 159A, 3 68093 00159 6; Atwater Carey, First Aid Kit Backpacker , 160A, 3 68093 00160 2; Atwater Carey, First Aid Kit Light & Dry LDI, 273, 3 68093 00273 9; Atwater Carey, First Aid Kit Light & Dry LD2, 274, 3 68093 00274 6; Atwater Carey, First Aid Kit Light & Dry LD3, 275, 3 68093 00275 3; Atwater Carey, Marine First Aid Kit, 299, 3 68093 00299 9. Recall # D-722-2011
CODE
Lot Number (Product Name) 892131 (Personal First Aid Kit) 881573, 901652 (Dayhiker First Aid Kit) 881574, 888918, 890443, 900545 (Backpacker First Aid Kit) 860968, 881490, 884651, 888922, 893091, 900546, 909915 (Light & Dry LD1 Kit) 881577, 888923, 902636, 904134, 908312 (Light & Dry LD2 Kit) 877590, 881578, 886855, 893093, 902635, 902637, 907450, 908311 (Light & Dry LD3 Kit) 888925 (Marine First Aid Kit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wisconsin Pharmacal Company, LLC, Jackson, WI, by letter dated April 14, 2011 and by press release on April 21, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: Wisconsin Pharmacal Company LLC has initiated the recall due to a recall being conducted for the Triad Povidone Iodine Prep Pads manufactured by H&P Industries, Inc. Concerns were expressed by the Food and Drug Administration regarding the potential contamination of Triad Povidone Iodine Prep Pads. The Triad Povidone Iodine Prep Pads are potentially contaminated with an objectionable organism, Elizabethkingia meningoseptica. The Triad Povidone Iodine Prep Pads have an NDC number of 50730-3201-1 and are the only defective material in the First Aid Kits.
VOLUME OF PRODUCT IN COMMERCE
8,521 kits
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
G & W Bacitracin Ointment First Aid Antibiotic. Recall # D-713-2011
CODE
Lot # 028009009, Expiration Date July 2011; Lot # 028009006, Expiration Date May 2011
RECALLING FIRM/MANUFACTURER
G & W Laboratories Inc., South Plainfield, NJ, by letters on April 21, 2011. Firm initiated recall is ongoing.
REASON
Stability data does not support exp; failed 18-month stability test for microbiological assay.
VOLUME OF PRODUCT IN COMMERCE
65,376 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Bisacodyl delayed-release enteric coated tablets, USP, 5 mg, 100-count bottle, NDC 0603-2483-21, UPC 3 0603-2483-21 1. Recall # D-719-2011;
 
2) Doc Q Lace (docusate sodium) softgels, 100 mg, 100-count bottle, NDC 0603-0145-21, UPC 3 0603-0145-217. Recall # D-720-2011;
CODE
1) Lot #: J071W, Exp 09/13;
 
2) Lot #: 103030, 103031, 103033, Exp 02/13; 103032, 104010, 104011, 104012, 104013, 104014, 105015, Exp 03/13; 105011, 105013, Exp 04/13  
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters dated July 11, 2011.
Manufacturers: Time-Cap Laboratories, Inc., Farmingdale, NY;
Swiss Caps USA, Inc., Miami, FL. Firm initiated recall is ongoing. Firm initiated recall is ongoing.
REASON
Labeling: Tablets/Capsule Imprinted W/Wrong I.D.: Incorrect product code printed on products.
VOLUME OF PRODUCT IN COMMERCE
71,400 bottles
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1381-11
CODE
Units: R23959, J06578
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on July 24, 2009. 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
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1545-11
CODE
Unit: # G19011
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on October 27, 2008 and by letter dated February 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1612-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1613-11
CODE
1) and 2) Unit: W128708013998
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and facsimile on December 31, 2008 or January 2, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1616-11;
2) Fresh Frozen Plasma. Recall # B-1617-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1618-11;
4) Recovered Plasma. Recall # B-1619-11
CODE
1) Unit: 1269827;
2) Unit: 8225976;
3) Units: 8208190; 8506204; 8225976; 8247892; 8008477; 8700662;
4) Units: 1269827; 8208190; 8506204; 8247892; 8008477; 8700662
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on December 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from previously deferred donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
CA, NJ and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1621-11
CODE
Unit: W128708016088
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on December 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-1629-11
CODE
Unit: W0352110312665
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated May 25, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not tested for pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1693-11
CODE
Unit: W038510385512
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 7 and February 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1697-11
CODE
Units: 017FR94348; 017LG20632
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 19, 2011. Firm initiated recall is complete.
REASON
Blood products, phenotyped positive for the Jk(a)antigen but labeled as Jk(a) antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1729-11
CODE
Units: W128710061831(part 1); W128710061831(part 2)
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated April 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________ ___________________________________
PRODUCT
Source Plasma. Recall # B-1735-11
CODE
Unit: 11MTNA5065
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 ________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1738-11
CODE
Units: 22FR31863; 22FR32077; 22GZ52069; 22LC82010; 22LC82019
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and letter on April 22, 2011. Firm initiated recall is complete.
REASON
Blood products, positive for the E-antigen but labeled as E-antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1739-11
CODE
Units: 22FS46558 Part 1; 22FS46558 Part 2
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on April 12, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1746-11
CODE
Units: 017GV92560, 017GV92738
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 23, 2011 and by letters dated April 1, 2011 and April 25, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma. Recall # B-1748-11
CODE
Units: I75119280; I75118994; I75118564; I75118312; I75117828; I75117163; I75116852; I75116422; I75116167; 391005022; 391003441; 391002655; 391002120; 391001831; 391001295; 391001051; 391000502; I75120250; I75110668; I75110249; I75109946; I75108482; I75108176; I75107695; I75107407; I75106729; I75106172; I75103172; I75103608; I75103905; I75104802; I75105119; I75109076; I75109393; I75105845; I75100317; I75100614; I75100950; I75101451; I75101732; I75102150; I75102431; I75102850; I75092752; I75093016; I75098206; I75098471; I75098881; I75099316; I75089934; I75090674; I75091017; I75091262; I75091600; I75091825; I75092150; I75092391; I75087714; I75088249; I75088474; I75088767; I75088987; I75089329; I75089589; I75085850; I75086073; I75086333; I75086502; I75086909; I75081458; I75082015; I75082569; I75082969; I75085319; I75085574; I75075395; I75076447; I75077055; I75078586; I75079108; I75079691; I75080274; I75080850; I75067608; I75068176; I75071039; I75071733; I75072210; I75072733; I75073725; I75074266; I75061344; I75063924; I75064520; I75065090; I75065572; I75066064; I75066583; I75067068; I75057187; I75057693; I75058235; I75058716; I75059215; I75059719; I75060247; I75060768; I75052150; I75052720; I75053249; I75053738; I75054095; I75054620; I75055621; I75056635; I75049283; I75044242; I75045309; I75047471; I75047978; I75048487; I75049982; I75050522; I75048701; I75043121; I75042528; I75041954; I75041394; I75040837; I75036345; I75036308; I75086731; I75087403; I75087192; I75087928
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., North Las Vegas, NV, by telephone and facsimile on June 9, 2007. 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
135 units
DISTRIBUTION
CA, KY, NC, NV and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1749-11
CODE
Unit: W045011024680
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by fax on June 11, 2011. 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
MO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1750-11
CODE
Units: 7206271; 7206271
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 12, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the QC requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1751-11
CODE
Unit: W142810357308
RECALLING FIRM/MANUFACTURER
Tri-counties Blood Bank, San Luis Obispo, CA, by letter dated June 13, 2011. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1754-11
CODE
Unit: 70200728640
RECALLING FIRM/MANUFACTURER
Csl Plasma, Inc., Aurora, CO, electronically on May 4, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received an accidental needlestick within 3 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1766-11;
2) Cryoprecipitated AHF. Recall # B-1767-11
CODE
1) and 2) W035210002179Q
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX, NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1774-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1775-11;
3) Cryoprecipitated AHF. Recall # B-1776-11
CODE
1) Unit: W053310603542;
2) Units: W053309607211; W053309605013; W053309603116; W053308605365; W053310608876; W053310606359;
3) Unit: W053310606359
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton WI, by telephone and follow-up letter on May 4, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Switzerland, MA, NY, MO, MS, WI
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1777-11;
2) Cryoprecipitated AHF. Recall # B-1778-11;
3) Cryoprecipitated AHF, Pooled. Recall # B-1779-11
CODE
1) Unit: W036510044604;
2) Units: W036510044604; W036510153556;
3) Unit: W036510153556
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport LA, by facsimile on May 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland and LA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1780-11;
2) Cryoprecipitated AHF, Pooled. Recall # B-1782-11
CODE
1) Unit: 16KJ72174;
2) Unit: 16N43286
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, NJ, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated Washed. Recall # B-1783-11
CODE
Unit: W066510602196
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by telephone on May 24, 2011 and facsimile on June 7, 2011. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to antigen phenotype, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1784-11
CODE
Unit: W041011033640* (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Albuquerque, New Mexico, by telephone on March 29, 2011.
Manufacturer: Blood Systems, Inc dba United Blood Services, Scottsdale, AZ. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as negative for the Kell antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
New Mexico
____________________________________
PRODUCT
Source Plasma Recall # B-1786-11
CODE
Unit: 5030111748
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Atlantic Beach, FL, by facsimile on May 11, 2011. Firm initiated recall is complete.
REASON
Blood product, for which the sample for viral marker testing may have been diluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets. Recall # B-1787-11
CODE
Unit: W087211004273
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone and facsimile on April 25, 2011. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that may have been contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1788-11
CODE
Unit: F24440
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by electronic notification on May 20, 2011. 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
Switzerland
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1789-11
CODE
Unit # 53GG50054
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 5, 2011. Firm initiated recall is complete.
REASON
Blood product, for which the quality control testing was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1790-11
CODE
Unit: W158011600314
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by e-mail on May 20, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT
___________________________________
PRODUCT
1) Cryoprecipitated AHF, Pooled. Recall # B-1791-11;
2) Recovered Plasma. Recall # B-1792-11;
3) Red Blood Cells.  Recall # B-1793-11;
4) Fresh Frozen Plasma. Recall # B-1794-11
CODE
1) Unit: W035410057932;
2) Unit: W035410068461;
3) Units: W035410068461, W035410033438;
4) Unit: W035410033438
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on May 12, 2011 and by facsimile on May 13 and 17, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Austria, OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1797-11
CODE
Unit: 7203222
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on May 12, 2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1799-11;
2) Platelets. Recall # B-1800-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1802-11
CODE
1) Units: W0352092626557; 9569604; W035209132071U;
2) Units: 9569604; W035209132071U;
3) Units: 9569604; W035209132071U; W0352092626557
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
TN, TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________
PRODUCT
Recovered Plasma. Recall # B-1620-11
CODE
Unit: W128708016088
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on December 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1709-11
CODE
Units: W128709060865, W128709010584
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated March 6, 2009. Firm initiated recall is complete.
REASON
Blood product, was labeled with incorrect anticoagulant and product volumes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1712-11;
2) Red Blood Cells. Recall # B-1713-11
CODE
1) Unit: P78322;
2) Units: T30644, P44737
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile dated March 16, 2009 and letter dated June 26, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking Doxycycline, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1733-11;
2) Fresh Frozen Plasma. Recall # B-1734-11
CODE
1) and 2) Unit: 2076869
RECALLING FIRM/MANUFACTURER
Hemacare Corp., Van Nuys, CA, by telephone on March 23, 2011 and by letter on March 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested HIV positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1747-11
CODE
Unit: LT109376
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp. Las Vegas, NV, by facsimile on September 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1768-11
CODE
Unit: W035210002179Q
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX, NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1781-11
CODE
Unit: 16KJ72174
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, NJ, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1785-11
CODE
Unit: W038111046791 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by letter dated May 19, 2011.
Manufacturer: Florida's Blood Centers - Lake Worth, Palm Springs, FL. Firm initiataed recall is complete.
REASON
Blood products, which were stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1798-11
CODE
Unit: W089211024609
RECALLING FIRM/MANUFACTURER
Sanford Medical Center (Blood Bank), Sioux Falls, SD, by facsimile on June 7, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Source Leukocytes. Recall # B-1801-11
CODE
Unit: W035209132071U
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit  
DISTRIBUTION
TN, TX
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Condyle Kit with Hexalobular, REF 114700 Discovery Elbow System, Humeral Condyle Set - Hexalobular, CO-CR-MO YI-GAL-4V Alloy, If Used For Revision Surgery, Instruments 414926 & 414923 May be Required Lot 183300, 1 Set, Expiry Date: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications. Recall # Z-2660-2011
CODE
Lot # 183300
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated May 25, 2011. Firm initiated recall is ongoing.
REASON
The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.
VOLUME OF PRODUCT IN COMMERCE
10 kits
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings. Recall # Z-2662-2011
CODE
MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs
RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter on March10, 2011. Firm initiated recall is ongoing.
REASON
There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.
VOLUME OF PRODUCT IN COMMERCE
840 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Sequoia final driver closure top retention, non-sterile, REF 3384-2. The device is used to apply final torque to closure tops of the implant. The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal. Recall # Z-2705-2011
CODE
Units: 60LJ, 60LK, 60LL, 61HZ, 61RS, 64DC, 64DC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated April 4, 2011.
Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.
VOLUME OF PRODUCT IN COMMERCE
505 units
DISTRIBUTION
Nationwide, Czech Republic, Denmark, France, Singapore, Spain, Switzerland, and United Kingdom
___________________________________
PRODUCT
SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports). Recall # Z-2714-2011
CODE
Versions 1.1.6.x and 1.1.7.x.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter dated June 9, 2010. Firm initiated recall is ongoing.
REASON
Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System, part number 07-008, catalog number REF 8002. Recall # Z-2742-2011
CODE
Lot numbers HMO196 and HMO197, expiration date July 2011
RECALLING FIRM/MANUFACTURER
Haemoscope Division of Haemonetics Corp., Niles, IL, by letter dated March 2, 2011. Firm initiated recall is ongoing.
REASON
Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
VOLUME OF PRODUCT IN COMMERCE
568 kits
DISTRIBUTION
Nationwide, Canada, Czech Republic and the Philippines
___________________________________
PRODUCT
Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, Sterile. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter. Recall # Z-2746-2011
CODE
Lot #s: 10306012, 10323012, 10340022, 11007012 and 11047012
RECALLING FIRM/MANUFACTURER
Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated May 27, 2011. Firm initiated recall is ongoing.
REASON
The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.
VOLUME OF PRODUCT IN COMMERCE
87 Boxes/435 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560. Recall # Z-2747-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by letter dated May 19, 2011.
Manufacturer: Covidien LP, Mansfield, MA. Firm initiated recall is ongoing.
REASON
A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis.
VOLUME OF PRODUCT IN COMMERCE
13,942 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. It has a System Part Number: 989605392501, 989605396032, 989605395201. Tool Connection Unit Part Number: 453561426002, 453561443201 The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another. Recall # Z-2769-2011
CODE
System Code Serial Numbers are: 03B8QR, B00DQ2, B00HZR, B00J3F, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, and B00PPP. The Tool Connection Units with the following serial numbers are: B00J0G, B00J0H, B00J0M, B00J0N, B00J0Q, B00J0R, B00J0X, B00J0Y, B00J10, and B00J20
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, byletter dated May 27, 2011.
Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.
REASON
PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide, Australia, India, Netherlands, and South Korea  
_________________________________
PRODUCT
Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands, H14, H19, H27, H29, Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-2778-2011
CODE
Serial Numbers: H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 13, 2011. Firm initiated recall is ongoing.
REASON
Some drive stand bolts may fail to meet mechanical specifications.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide, Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom
___________________________________
PRODUCT
Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-2782-2011
CODE
Serial numbers: DYUJA023, DYUJA024, DYUJA025, DYUJA026, DYUJA027, DYUJA028, DYUJA029, DYUJA030, DYUJA031, DYUJA032, DYUJA034, DYUJA036, DYUJA037, DYUJA038, DYUJA039, DYUJA040, DYUKA001, DYUKA002, DYUKA003, DYUKA004, DYUKA005, DYUKA006, DYUKA007, DYUKA008, DYUKA009, DYUKA010, DYUKA011, DYUKA012, DYUKA013, DYUKA014, DYUKA015, DYUKA015, DYUKA017, DYUKA018, DYUKA019, DYUKA020, DYVAA001, DYVAA002, DYVAA003, DYVAA004, DYVAA005, DYVAA006, DYVAA007, DYVAA012, DYVAA013, DYVAA014, DYVAA015, DYVAA016, DYVAA017, DYVAA018, DYVAA019, DYVAA020, DYVAA021, DYVAA022, DYVAA023, DYVAA024, DYVAA025, DYVAA026, DYVAA027, DYVAA028, DYVAA029, DYVAA030, DYVAA031, DYVAA032, DYVAA033, DYVAA036, DYVAA037, DYVAA038, DYVAA039, DYVAA040, DYVBA002, DYVBA003, DYVBA004, DYVBA005, DYVBA006, DYVBA007, DYVBA008, DYVBA009, DYVBA010, DYVBA011, DYVBA012, DYVBA013, DYVBA014, DYVBA015, DYVBA018, DYVBA019, DYVBA020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 2011.
Manufacturer: Dymax Corp., Warrendale, PA. Firm initiated recall is ongoing.
REASON
Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection. a) Catalog number: A1300VA, b) Catalog number: A1300. Recall # Z-2831-2011
CODE
a) Lot number: 02E1002552; b) Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302
RECALLING FIRM/MANUFACTURER
Teleflex Medical, Durham, NC, by letter dated June 27, 2011. Firm initiated recall is ongoing.
REASON
The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
6,880 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: "Marus Dental". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures. Recall # Z-2834-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Dental Equipment LLC, Newberg, OR, by letter on June 24, 2011. Firm initiated recall is ongoing.
REASON
Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.
VOLUME OF PRODUCT IN COMMERCE
13,258 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
OneTouch Delica Lancing Device; Testing of Blood Glucose Levels. Model Number 022-137-01. Recall # Z-2835-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifescan Inc., Milpitas, CA, by letter dated May 27, 2011.
Manufacturer: Facet Technologies LLC, Kennesaw, GA. Firm initiated recall is ongoing.
REASON
Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
VOLUME OF PRODUCT IN COMMERCE
1,032,515
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit. Product code: CLXUSA. Recall # Z-2839-2011
CODE
Lot: Y302
RECALLING FIRM/MANUFACTURER
Therakos Inc., Raritan, NJ, by letter dated December 2, 2010. Firm initiated recall is ongoing.
REASON
Cellex Procedural kits may have minor tears in their Tyvek covers.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Bongards' creameries Perham Whey Proteins, Pc-Protein, Net Weight:  19.95806 KG / 44 lbs. Product Guarantee: Crude Protein.....55.0% Min. Crude Fat.....10% Min. Crude Fiber.....0.0% Max., Carbohydrate.....35.0% Max. whey Protein Concentrate (a milk derivative). Recall # V-371-2011
CODE
Lot numbers: 110110, 110210, 110510, 111110, 111210, 111510, 111710, 111810, 112110, 112210, 112610, 112710, 120110, 120210, 120710, 120810, 121510, 122310, 122410, 010311, 010411, 010911, 011011, 011511, 011611
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bongards' Creameries, Norwood Young America, MN, by letterdated May 1, 2011.
Manufacturer: Bongards' Creameries, Perham, MN. Firm initiated recall is ongoing.
REASON
Bongards' Creameries is recalling a limited quantity of Pc-Protein powder because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
567,468 lbs
DISTRIBUTION
MN, MT
 
END OF ENFORCEMENT REPORT FOR JULY 27, 2011
 
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