Safety
Enforcement Report for May 9, 2012
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
PRODUCT
1) Crispy by TWI Foods Almond Cookies, Biscuit Almande, Net wt. 200 g/7 oz, 14 packages/case; Product of Canada; UPC 6 27265 00520 7; UPC 6 27265 00522 1. Recall # F-1174-2012;
2) Crispy by TWI Foods Coconut Cookies, Biscuit Noix de coco, Net wt. 200 g/7 oz, 14 packages/case; Product of Canada; UPC 6 27265 00521 4. Recall # F-1175-2012;
3) Crispy by TWI Foods Pistachio Cookies, Biscuit pistache, Net wt. 200 g/7 oz, 14 packages/case; Product of Canada, UPC 6 27265 00161 2. Recall # F-1176-2012
CODE
1) and 3) All best before dates up to and including 29/MAR/13;
2) All best before dates up to and including 23/MAR/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raja Foods, L.L.C., Skokie, IL, by letters dated April 25, 2012.
Manufacturer: Twi Foods Inc., Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON
Cookies did not declare milk and almonds on the labeling.
VOLUME OF PRODUCT IN COMMERCE
215 cases
DISTRIBUTION
Nationwide, St. Thomas U.S. Virgin Islands, and Panama
PRODUCT
1) Crispy Pistachio Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 200g/0.44lb (7oz) ***Ingredients: Wheat flour, sugar, soybean oil margarine, modified milk***, cornstarch, vegetable based soy protein, pistachio, salt, ammonium carbonate, artificial flavor.***6 27265 00161 2***". Recall # F-1177-2012;
2) Crispy Coconut Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***COCONUT COOKIES***Just Baked!***Biscuit noix de coco***Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, corn starch, dessicated coconut, vegetable based soy protein, corn syrup, artificial flavor, salt, ammonium carbonate.***PRODUCT OF CANADA***6 27265 00521 4***Net Wt./Poids Net 200g/0.44 lb(7.0 oz)***". Recall # F-1178-2012;
3) Crispy Almond Cookie product is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***ALMOND COOKIES***Just Baked!***BISCUIT ALMANDE***Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, cornstarch, almond, vegetable based soy protein, corn syrup, artificial flavor, salt and ammonium carbonate.***Net Wt./Poids Net 200g/0.44 lb(7 oz)***PRODUCT OF CANADA***6 27265 00522 1***". Recall # F-1179-2012;
4) Crispy Almond Cake Rusk product is labeled in part: "***CRISPY***TWI FOODS***ALMOND CAKE RUSK***BISCOTTE CROUSTILLANTE ALMANDE***Ingredients: Wheat Flour, vegetable oil (canola & soybean), margarine, sugar, liquid whole egg, almonds, walnut, funnel seed, baking powder, artificial flavor.***Net Wt./Poids Net 750 g/16.4 oz***Product of Canada/Produit du Canada***6 27265 00217 6***". Recall # F-1180-2012
CODE
All Lots All Codes w/expiration date up to 03/29/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Commerce International Inc., Orlando, FL, by telephone on April 5, 2012.
Manufacturer: Twi Foods Inc., Mississauga Ontario, Canada. FDA initiated recall is ongoing.
REASON
The products may contain undeclared milk and almonds.
VOLUME OF PRODUCT IN COMMERCE
258 cases
DISTRIBUTION
St Thomas VI, FL, GA, NC, SC and TN
PRODUCT
GFS Brand Hostess Mix 48oz stand up pouch assorted hard candy mix which was packaged in GFS Chocolate Sprinkles bag. Package labeling: ***GFS***HOSTESS MIX***NET WT/PESO NETO 48 OZ (3LB) 1.36 kg***BUTTER TOFFEE***INGREDIENTS: SUCROSE, CORN SYRUP, BUTTER OIL, WHEY POWDER, SALT, NATURAL AND ARTIFICIAL FLAVOR, SOY LECITHIN, SODIUM BICARBONATE AND COCOA POWDER.***CONTAINS: MILK, SOY, AND WHEAT.*** Packaged in 64 oz stand up pouch of CHOCOLATE SPRINKLES Package Labeling: ***GFS***CHOCOLATE SPRINKLES***NET WT/PESO NETO 64 OZ (4 LB) 1.81 kg***INGREDIENTS: SUGAR, CORN STARCH, PARITLALY HYDROGENATED VEGATABLE OIL (COTTONSEED, SOYBEAN), COCOA (COCOA PROCESS WITH ALKALI), DEXTRIN, SOYA LECITHIN, CONFECTIONERS GLAZE, NATURAL AND ARTIFICIAL FLAVOR, CARNAUBA WAX.***CONTAINS: SOY.*** UPC code: 093901682598 Case identification (GFS Hostess Candy Mix): GFS and GFS item number: 682590 If case has already been open then: Bag identification (GFS Chocolate Sprinkles bag): GFS item number: 283650. Recall # F-1187-2012
CODE
Lot code 09312; Lot number: 08812
RECALLING FIRM/MANUFACTURER
Recalling Firm: Krispak Inc., Grand Rapids, MI, by telephone and letter dated April 23, 2012.
Manufacturers: Krispak Inc., Grand Rapids, MI;
GFS 50TH ST. Distribution Center, Grand Rapids, MI. Firm initiated recall is ongoing.
REASON
A small number of cases of GFS Hostess Candy Mix were put into GFS Chocolate Sprinkles packages. GFS Hostess Candy Mix contains wheat and milk and may contain egg, none of which are declared on the GFS Chocolate Sprinkles package.
VOLUME OF PRODUCT IN COMMERCE
162 cases
DISTRIBUTION
FL, WI, OH, PA, TN, MI, IN
PRODUCT
Product is a pimento cheese spread packaged in clear plastic containers containing 7oz and with a clear plastic snap-on lid. Product lid is labeled in part: "Mrs. Weaver's Pimento Spread Nutrition Facts***KEEP REFRIGERATED Net Wt 7 oz. (198G)***" THE LID IS LABELED WITH THE UPC: "0 71117 00003 0" which is specific to the pimento spread. ***". The CUP portion of the container is labeled in part: "Mrs. Weaver's Pimento Spread Net Wt 7 oz***INGREDIENTS: American Cheese***casein [milk protein]***". The cup section of the ham salad containers are labeled in part: "Mrs. Weaver's Ham Salad***INGREDIENTS: Chopped Ham***". Recall # F-1188-2012
CODE
USE BY AUG/05/12 20
RECALLING FIRM/MANUFACTURER
Recalling Firm: Resers Fine Foods, Beaverton, OR, by e-mail and telephone on April 23, 2012 and by press release on April 25, 2012.
Manufacturer: Resers Fine Foods Inc., Topeka, KS. Firm initiated recall is ongoing.
REASON
Part of production run of pimento spread which contains the allergen milk was packaged in containers labeled for ham salad which does not declare milk allergen. The containers are a clear plastic with a clear plastic snap-on lid. Some of the product was packaged in the cup section of containers labeled as Ham Salad, however the lids used on all the affected product was the correct lid for Pimento Spread.
VOLUME OF PRODUCT IN COMMERCE
653 cases each containing 12 7 oz units (7836 units)
DISTRIBUTION
AR, AZ, FL, LA, MS, OK, TX, WA
PRODUCT
Crispy TWI Foods Almond Cake Rusk, Net Wt. 750 g UPC 6 27265 00217 6, Product of Canada. Recall # F-1189-2012
CODE
Code 12058 Best Before Feb 27, 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Exotic Products Inc., Milford, MA, by telephone on March 26, 2012.
Manufacturer: Twi Foods Inc., Mississauga, Ontario, Canada. Firm initiated recall is complete.
REASON
Almond rusk cake did not declare milk in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
10 cases
DISTRIBUTION
MA
PRODUCT
1) YELLOWFIN TUNA AA NAKAOCHI SCRAPE INDIVIDUALLY VACUUM PACKED INGREDIENTS FROZEN TUNA AND CARBON MONOXIDE (TO PROMOTE COLOR RETENTION) CRYOGENICALLY FROZEN PRODUCT OF INDIA (WILD CAUGHT) NOT FOR RETAIL SALE NET WT. 22 LBS (10 KGS) To be Cooked before consumption. Recall # F-1190-2012;
2)YELLOWFIN TUNA AAA NAKAOCHI SCRAPE INDIVIDUALLY VACUUM PACKED INGREDIENTS FROZEN TUNA AND CARBON MONOXIDE (TO PROMOTE COLOR RETENTION) CRYOGENICALLY FROZEN PRODUCT OF INDIA (WILD CAUGHT) NOT FOR RETAIL SALE NET WT. 22 LBS (10 KGS). To be Cooked before consumption. Recall # F-1191-2012
CODE
All Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Moon Marine (U.S.A) Corp, Cupertino, CA, by letters on April 12, 2012 and April 14, 2012 and by e-mail and/or telephone on April 13, 2011.
Manufacturer: Moon Fishery India PVT LTD, Cochin, India. FDA initiated recall is ongoing.
REASON
Epidemiological evidence in Salmonella Bareilly outbreak points to tuna imported and distributed by MMI Food Corporation.
VOLUME OF PRODUCT IN COMMERCE
2344 cases (22 lbs per case)
DISTRIBUTION
IL, NJ, NY, MA, GA, NC, TX, MD
PRODUCT
1) Crispy Almond Cake Rusk product is labeled in part: "***CRISPY***TWI FOODS***ALMOND CAKE RUSK***BISCOTTE CROUSTILLANTE ALMANDE***Ingredients: Wheat Flour, vegetable oil (canola & soybean), margarine, sugar, liquid whole egg, almonds, walnut, funnel seed, baking powder, artificial flavor.*** Net Wt./Poids Net 750 g/16.4 oz***Product of Canada/Produit du Canada***6 27265 00217 6***". Recall # F-1192-2012;
2) Crispy Almond Cookie product is labeled in part: "***VEGETARIAN***NO EGG*** CRISPY***By TWI Foods***ALMOND COOKIES***Just Baked!***BISCUIT ALMANDE*** Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, cornstarch, almond, vegetable based soy protein, corn syrup, artificial flavor, salt and ammonium carbonate.***Net Wt./Poids Net 200g/0.44 lb(7 oz)***PRODUCT OF CANADA***6 27265 00522 1***". Recall # F-1193-2012;
3) Crispy Coconut Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***COCONUT COOKIES***Just Baked!***Biscuit noix de coco*** Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, corn starch, dessicated coconut, vegetable based soy protein, corn syrup, artificial flavor, salt, ammonium carbonate.***PRODUCT OF CANADA***6 27265 00521 4***Net Wt./Poids Net 200g/0.44 lb(7.0 oz)***". Recall # F-1194-12;
4) Crispy Pistachio Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked! ***Biscuit Pistache***Net Wt. /Poids Net 200g/7 oz*** Ingredients: Wheat flour, soybean oil margarine, sugar, pista, cornstarch, (vegetable based soy lecithin and soy protein), corn syrup, baking powder, artificial flavor, salt, and ammonium carbonate. ***6 27265 00161 2***". Recall # F-1195-2012
CODE
All Lots All Code Dates up to 29/03/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chetak Orlando LLC, Kissimmee, FL, by email on April 4, 2012.
Manufacturer: Twi Foods Inc., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
REASON
The product may contain undeclared milk and/or almonds.
VOLUME OF PRODUCT IN COMMERCE
41 cases
DISTRIBUTION
FL
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT
1) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***SIN ALCOHOL***MR. SPECIAL MALTA*** 7FL. OZ. (207 ml.)***A MALT BEVERAGE BREWED FROM WATER, BARLEY MALT, FRUCTOSE, CORN SYRUP, MELLO MALT, AND HOPS***" Affected Lot Codes: 11/30/13, 12/01/13, 12/08/13, 12/09/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 008254820702. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1013-2012;
2) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***NON ALCOHOLIC***MALTA GOYA Malt Beverage***NET WT. 7 FL. OZ. (207 ml.)***INGREDIENTS: WATER, BARLEY MALT, FRUCTOSE, CORN SYRUP, MELLO MALT, AND HOPS***" Affected Lot Codes: 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 041331040068. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1014-2012;
3) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***SuperMax***MALTA MALT BEVERAGE NON ALCOHOLIC***NET WT. 7 FL. OZ. (207 ml.)***INGREDIENTS: BARLEY MALT, MELLO MALT, CORN SYRUP, FRUCTOSE AND HOPS.***" Affected Lot Codes: 12/09/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 870906000691. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1015-2012;
4) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***malta polar Non-Alcoholic Malt Beverage***7 fl. oz. /207 ml.***POLAR***BREWED AND BOTTLED BY THE FLORIDA BREWERY, INC. AUBURNDALE, FL 33123***INGREDIENTS: WATER, MALTED BARLEY, SUGAR, HOPS, CARBON DIOXIDE.***" Spanish Label: "***Puerto Rico***malta polar***Malta sin Alcohol***7fl. oz./207 ml.***POLAR***. INGREDIENTS: AGUA, CEBADA, MALTAEADA, AZUCAR, LUPULO Y CO2.***" Affected Lot Codes: 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/13, 01/04/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 7591446006785 and 7591446006761. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1016-2012;
5) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***MALTA HATUEY A NON ALCOHOLIC CEREAL BEVERAGE***FRUCTOSE, CORN SYRUP, MELLO MALT, CARAMEL, MALT, AND HOPS***7 FL. OZ. (207 ml.)***" Affected Lot Codes: 12/21/13, 12/22/13, 01/06/13, 01/07/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 080480594909. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1017-2012;
6) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***MALTA REGAL***INGREDIENTS: WATER, BARLEY MALT, FRUCTOSE, CORN SYRUP, MELLO MALT AND HOPS***PUERTO RICO***7 FL. OZ. (207ml).***" Affected Lot Codes: 12/01/13, 12/09/13, 12/27/13, 12/28/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 082502738889; Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1018-2012;
7) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***Publix Malta***MALT BEVERAGE*** 7 FL OZ (207mL)***A NON-ALCOHOLIC MALT CEREAL BEVERAGE***INGREDIENTS: WATER, BARLEY MALT, FRUCTOSE, CORN SYRUP, MELLO MALT AND HOPS***" Affected Lot Codes: 11/28/13, 12/09/13, 12/27/13. Lot Codes are found on the glass bottle above the primary display panel. UPC 041415109360. Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. F-1019-2012;
8) Products are packaged in 7 oz glass bottles with twist-off caps and are labeled in part: "***Great Value***Malta***No alcoholic***Malt beverage***NET 7 FL OZ (207Ml)***INGREDIENTS: WATER, BARLEY MALT, CARAMEL, MALT, MELLO MALT, CORN SYRUP, FRUCTOSE AND HOPS*** " Affected Lot Codes: 1/05/13 and 1/26813. Lot Codes are found on the glass bottle above the primary display panel. UPC 681131762793; Brands include: Goya Brand UPC 041331040068 Lot Codes 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13; Great Value Brand UPC 681131762793 Lot Codes 1/05/13 and 1/06/13; Hatuey Brand UPC 080480594909 Lot Codes 12/21/13, 12/22/13, 01/06/13, 01/07/13; Mr. Special Brand UPC 008254820702 Lot Codes 11/30/13, 12/01/13, 12/08/13, 12/09/13; Polar Brand UPC 7591446006785 and 7591446006761 Lot Codes 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/12, 01/04/13; Publix Brand UPC 041415109360 Lot Codes 11/28/13, 12/09/13, 12/27/13; Regal Brand UPC 082502738889 Lot Codes 12/01/13, 12/09/13, 12/27/13, 12/28/13; and Super Max Brand UPC 870906000691 Lot Code 12/09/13. Recall # F-1020-2012
CODE
1) Lot Codes: 11/30/13, 12/01/13, 12/08/13, 12/09/13;
2) Lot Codes: 12/01/13, 12/08/13, 12/27/13, 12/28/13, 12/29/13, 01/06/13;
3) Lot Codes: 12/09/13;
4) Lot Codes: 11/30/12, 12/22/12, 12/23/12, 12/29/12, 12/30/12, 01/03/13, 01/04/13;
5) Lot Codes: 12/21/13, 12/22/13, 01/06/13, 01/07/13;
6) Lot Codes: 12/01/13, 12/09/13, 12/27/13, 12/28/13;
7) Lot Codes: 11/28/13, 12/09/13, 12/27/13;
8) Lot Codes: 1/05/13 and 1/06/13
RECALLING FIRM/MANUFACTURER
The Florida Brewery, Inc., Auburndale, FL, by e-mail on February 17, 2012, by press release (English and Spanish versions) on February 22, 2012, and by letter on February 24, 2012. Firm initiated recall is ongoing.
REASON
Florida Brewery is recalling Malta Beverages in 7 oz glass bottles due to possible health risk. Glass on the exterior of the bottles may break when the twist-off cap is removed from the bottle and can result in cuts to the mouth.
VOLUME OF PRODUCT IN COMMERCE
145,110 cases
DISTRIBUTION
FL, TX, GA, CA, and PR
PRODUCT
Planters Cocktail Peanuts, Net Wt 12 Oz (340 g); shelled, roasted peanuts packaged in a paper-foil laminate canister with metal ends and a resealable plastic lid;12 canisters per case; UPC 0 29000 07212 1. Recall # F-1164-2012
CODE
Best When Used By Date 09-JAN-14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by a press release on April 6, 2012.
Manufacturer: Planters, Division of Kraft Foods, Inc., Suffolk, VA. Firm initiated recall is ongoing.
REASON
The peanuts were exposed to water not intended for use in food during the production process.
VOLUME OF PRODUCT IN COMMERCE
2,937 cases
DISTRIBUTION
Nationwide, PR, and the British Virgin Islands
PRODUCT
Odwalla Protein Monster, Chocolate Protein, soy and Dairy Protein Shake; 90% Organic Ingredients. Pasteurized, Gluten Free. Packaged in 12 oz and 32 oz re-sealable plastic bottles. Also sold in variety pack exclusively in Costco which contains 10 x 12 oz bottles, 4 of which are chocolate flavor. 25g Protein; 19% DV Potassium, 150% DV Vitamin B6, 150% DV Vitamin B12, 75% DV Calcium. Contains Soy and Milk. Brand Name Package Size Optimum Taste Codes UPC Odwalla Chocolate Protein Monster, 12-oz bottles, UPC 14054 13509; Odwalla Chocolate Protein Monster, 32-oz bottles;; UPC 14054 13504; Odwalla Protein Monster variety pack sold exclusively at Costco, Ten 12-oz bottles, 4 of the bottles are Odwalla Chocolate Protein Monster, UPC 0 14054 26659 6. Recall # F-1165-2012
CODE
All Enjoy by Date Codes prior to and including 23, MAY 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Odwalla Inc., Half Moon Bay, CA, by a press release and letters on April 5, 2012.
Manufacturer: Odwalla, Inc., Dinuba, CA. Firm initiated recall is ongoing.
REASON
The firm received four separate reports of allergic reactions from individuals who consumed the product. They reported known allergies to peanuts or peanuts and tree nuts.
VOLUME OF PRODUCT IN COMMERCE
Approximatly 250,000
DISTRIBUTION
Nationwide
PRODUCT
1) Valpo Velvet Gourmet Ice Cream, Peppermint Stick,Half Gallon (1.89L), UPC # 84842-44-140 and 1 Quart size, UPC # 84842-44157; Ingredients, Cream, Nonfat milk, sugar corn sugar, peppermint, gelatin, natural flavor, beet Extract, Lecithin, Red 40, Yellow 5, Blue 1. Recall # F-1167-2012;
2) Valpo Velvet Gourmet Ice Cream, Vanilla Chocolate Chip, Half Gallon (1.89L), UPC # 84842-44150; Ingredients, Cream, Nonfat milk, sugar corn sugar, cocoa, gelatin, vanilla, artificial flavor. Recall # F-1168-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Brown's Dairy, Inc., Valparaiso, IN, by visits beginning March 23, 2012 – March 29, 2012 and by letters April 13-19, 2012. FDA initiated recall is complete.
REASON
The firm uses and declares lecithin in the ingredient statement; however, the label does not list lecithin as "soy" lecithin.
VOLUME OF PRODUCT IN COMMERCE
3274 gallons total
DISTRIBUTION
IN, IL
PRODUCT
1) Boulder Ice Cream Organic Chocolate Pudding Ice Cream 3.6 oz. UPC 653888011028. Recall # F-1183-2012;
2) Boulder Ice Cream Organic Vanilla 1 pint, UPC 653888031002. Recall # F-1184-2012;
3) Boulder Ice Cream Organic Italian Espresso 3.6 oz, UPC 653888011387. Recall # F-1185-2012;
4)Boulder Ice Cream Organic Green Tea 1 pint. Recall # F-1186-2012
CODE
1) Lot #35587, Best By Date 03/15/13;
2) Lot #35585, Best By Date 03/06/13;
3) Lot #35909, Best By Date 03/08/13;
4) Lot #35712, Best By Date 03/12/13
RECALLING FIRM/MANUFACTURER
Fresca Foods, Inc., Louisville, CO, by telephone on April 20, 2012. Firm initiated recall is ongoing.
REASON
Organic raw milk may not be exposed to the full pasteurization controls before it was made into ice cream products.
VOLUME OF PRODUCT IN COMMERCE
708 cases
DISTRIBUTION
CO, CA
PRODUCT
1) Kolachy Bartz Bakery (Assorted) Cookies; INGREDIENTS: *** Pastry Dough: Wheat flour, water, sugar, margarine, butter, eggs, buttermilk, and cream of tartar. Raspberry Filling: Water, raspberries, corn syrup, modified corn starch, high fructose corn syrup, sugar, gellan, citric acid, sodium benzoate and potassium sorbate (preservative), natural and artificial flavor, agar, and artificial red color. Apricot Filling: Water, apricots (with sulphur dioxide), corn syrup, high fructose corn syrup, modified corn starch, sugar, malic acid, sodium benzoate and potassium sorbate (preservative), artificial flavor, salt, artificial yellow color. Walnut filling: walnuts, water, wheat flour, sugar, and salt. UPC: 7 18122 11783 3. Recall # F-1169-2012;
2) German Walnut Cookies Packaged in clear plastic containers containing approximately 10 cookies each. INGREDIENTS: Cookie *** Flour, Cake Flour, Walnuts, Sugar, Butter, Margarine, Eggs, Salt & Baking Soda. Contains Wheat, Nuts, Milk and Eggs. Minimum weight 16 oz. UPC: 7 18122 11793 2. Recall # F-1170-2012
CODE
1) Expiration date: 4/27/12;
2) Expiration date: 4/27/12, 4/29/12
RECALLING FIRM/MANUFACTURER
Bartz Bakery, Dearborn, MI, by visit on April 23, 2012. Firm initiated recall is ongoing.
REASON
1) The product contains undeclared colors - FD&C Yellow No. 6 and FD&C Red No. 40;
2) The product contains undeclared partially hydrogenated soybean oil, a sub-ingredient of margarine.
VOLUME OF PRODUCT IN COMMERCE
9 (16 oz) containers
DISTRIBUTION
MI
PRODUCT
1) Fisher Vanilla Bean with other natural flavors Almonds in Net Wt 10 oz. (283g) plastic cans, 6 cans per case; UPC 0 70690 02390 0. JBSS Item Code P02390. Recall # F-1172-2012;
2) Fisher Cocoa Mocha with other natural flavors Almonds in Net Wt 10 oz. (283g) plastic cans, 6 cans per case; Packed in U.S.A.; UPC 0 70690 02389 4. JBSS Item Code P02389. Recall # F-1173-2012
CODE
1) Best By 09/20/13 GH1 and 09/28/13/G1;
2) Best By 09/28/13 GH1
RECALLING FIRM/MANUFACTURER
John B. Sanfilippo & Son Inc., Elgin, IL, by e-mail and faxes on April 11, 2012, and by press release on April 12, 2012. Firm initiated recall is ongoing.
REASON
The almond products contain undeclared soy lecithin ingredients.
VOLUME OF PRODUCT IN COMMERCE
471 cases
DISTRIBUTION
WI
PRODUCT
Glazers donuts in 10.75 oz cardboard box, 6-count. UPC 39779 04033.
Recall # F-1181-2012
CODE
Sell by date on or before 04/07
RECALLING FIRM/MANUFACTURER
Kwik Trip Bakery, La Crosse, WI, by email on April 5, 2012 and by press release on April 6, 2012. Firm initiated recall is complete.
REASON
Product may contain undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
20,682 (6-count packages)
DISTRIBUTION
IA, MN, WI
PRODUCT
Product is barbeque flavored almonds packaged in metallized bags containing 2 oz of product. Labeling reads in part: "Harry & David***PREMIUM Kansas City Style Barbeque ALMONDS NET WT 2 OZ (56g) INGREDIENTS: ALMONDS, PEANUT OIL, SUGAR, SALT, ***SOYBEAN OIL***CONTAINS ALMONDS MAY CONTAIN TRACE AMOUNTS OF ALLERGENS NOT LISTED IN THE INGREDIENTS”. Recall # F-1182-2012
CODE
"Best by 09/28/12" and one of three following codes: "0682M", "0722M", and "0752M"
RECALLING FIRM/MANUFACTURER
Harry and David Operations, Inc., Medford, OR, by email with a follow-up phone call on April 10, 2012 and by press release on April 13, 2012. Firm initiated recall is ongoing.
REASON
Product may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
2016 2oz bags
DISTRIBUTION
CA, CO, DE, MD, NC, NJ, NV, OH, OR, VA
PRODUCT
Rajbhog Foods --- Vegetarian Delight --- Vegetable Biryani - A medley of vegetables sauteed with spices cooked with basmati rice and topped with cashews. Recall # F-1196-2012
CODE
Inner box liner U9299
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rajbhog Foods, Flushing, NY, by press release on April 9, 2012.
Manufacturer: Ethnic Foods, Inc. d/b/a Bombay Kitchen Foods. Port Washington, NY. FDA initiated recall is ongoing.
REASON
Product contains undeclared cashews.
VOLUME OF PRODUCT IN COMMERCE
38 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT
Minute Maid Orange Juice, 450 mL (15.2 oz), UPC 25000 05603. Recall # F-1171-2012
CODE
Codes beginning with APR0212US through JUL3012US
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca-Cola Refreshments USA, Inc., Atlanta, GA, by visit on March 26, 2012.
Manufacturer: Nor Cal Beverage Co Inc., West Sacramento, CA. Firm initiated recall is ongoing.
REASON
Possible pre-mature spoilage due to sporadic cap application.
VOLUME OF PRODUCT IN COMMERCE
163,547 cases (24 bottles /case)
DISTRIBUTION
AZ, CA, CO, HI, ID, KS, MT, NV, NM, OR, UT, WA and WI
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions toCDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
PRODUCT
NONE
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT
Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg, packaged in a) 30-day supply (3 blister cards x 60 tablets) 180 tablets per carton, NDC 0456-3330-60, UPC 3 0456-3330-60 5; b) 10 x 10 blister cards (100 tablets) per carton hospital unit dose, NDC 0456-3330-63, UPC 0 04563 33063 5; and c) 7-day supply (1 blister card x 42 tablets) per Patient Starter Kit, professional sample blister pack, NDC 0456-3330-42; Rx only. Recall # D-1332-2012
CODE
Lot #: a) 1069783, Exp 04/30/12; 1079546, 1082538, Exp 01/31/13; b) 1071614, Exp 04/30/12; 1072823, Exp 10/31/12; 1077653, 1078959, Exp 01/31/13; and c) 1073308, Exp 10/31/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by letters dated March 19, 2012.
Manufacturers: Merck Sante, Semoy, France;
Forest Pharmaceuticals Inc., Cincinnati OH.
Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Failing high results for the acid-stage dissolution test was obtained at the 18-month test interval.
VOLUME OF PRODUCT IN COMMERCE
24,469 blister packs and cartons
DISTRIBUTION
Nationwide and PR
PRODUCT
1) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Cherry Flavor 160 mg per 5 mL pain reliever/fever reducer a) 1 fl oz,. 30 mL UPC 011673574095, b) 2 fl oz, 60ml, UPC 011673574781, c) Twin Pack - 2 fl oz (60ml), UPC 011673574033, d) Twin Pack Promotion - 2 fl oz UPC 011673257424. Recall # D-1335-2012;
2) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Grape Flavor 160 mg per 5 mL pain reliever/fever reducer 2 fl oz. 60 mL UPC 011673602781. Recall # D-1336-2012
CODE
1) Units: 574-3426 09/2013 574-3427 09/2013 574-3428 09/2013 574-3439 09/2013 574-3445 09/2013 574-3446 09/2013 574-3502 10/2013 574-3669 11/2013 574-3670 12/2013 574-3671 12/2013 574-3691 12/2013 574-3692 12/2013 574-3714 12/2013 574-3715 12/2013 574-3732 12/2013 374-3760 01/2014 574-3761 01/2014;
2) Unit: 602-3716 12/2013
RECALLING FIRM/MANUFACTURER
Guardian Drug Co. Inc., Dayton, NJ, by letter on April 16, 2012 and issued a web site notification on April 24, 2012. Firm initiated recall is ongoing.
REASON
Mislabeling: Infant acetaminophen suspension product labeling was missing the statement "Under 2 years ask doctor" and the weight-based dosing of the label provides for doses that are higher than what has been recommended for children 2 years and older.
VOLUME OF PRODUCT IN COMMERCE
260,424 cartons
DISTRIBUTION
MN
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT
Lorazepam Oral Concentrate, USP, 2 mg/mL, Rx Only, 30 mL bottle, NDC 0574-0163-30. Recall # D-1333-2012
CODE
Lot #s: 2010302121, Exp 07/2012; 2010392922, Exp 09/2012; 2010514031, Exp 12/2012; 2011084759, Exp 02/2013; 2011145313, Exp 04/2013; 2011235889, Exp 06/2013
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letter dated April 4, 2012. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: This recall has been initiated due to non-conformance to the specification for a specified impurity (Related Compound C) at the 12-month stability test station
VOLUME OF PRODUCT IN COMMERCE
93,354 Bottles
DISTRIBUTION
Nationwide
PRODUCT
Losartan Potassium Tablets USP, 50 mg, 1000 film coated tablets, NDC 16714-582-03. Recall # D-1334-2012
CODE
Lot #G00921A EXP AUG 2013 Lot #G00922A EXP AUG 2013 Lot #G00923A EXP AUG 2013
RECALLING FIRM/MANUFACTURER
Actavis Pharma Manufacturing Private Limited, Kanchipuram, India, by letters dated January 5, 2012. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance; magnesium stearate excipient used in the product was found to be contaminated with zeolite, calcium hydroxide, dibenzoylmethane and Bisphenol A (BPA).
VOLUME OF PRODUCT IN COMMERCE
302 bottles
DISTRIBUTION
TN
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1027-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-1028-12;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-1029-12;
4) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1030-12
CODE
1) Units: 228386389, 228397461;
2) Units: 228386402, 228395335, 228397291;
3) Units: 224682603, 224682662, 224682672, 228385935, 228385955, 228386008, 228386044, 228386251, 228386282, 228386376, 228386389, 228386393, 228386413, 228386425, 228386429, 228388875, 228388892, 228388898, 228388908, 228389060, 228389087, 228389124, 228389137, 228390434, 228392801, 228393054, 228393069, 228395226, 228395270, 228395275, 228395280, 228395335, 228395415, 228397036, 228397070, 228397074, 228397129, 228397142, 228397160, 228397262, 228397274, 228397348, 228397370, 228397390, 228397406, 228397438, 228397461, 228397473, 228397765, 228397783, 228397796, 224682603, 224682672, 228382636, 228385955, 228386251, 228386282, 228386376, 228386425, 228386429, 228388875, 228388892, 228389087, 228389137, 228389141, 228393069, 228393124, 228395280, 228395415, 228397036, 228397070, 228397160, 228397262, 228397348, 228397473, 228397765, 228397783, 228397796, 228385955, 228386251, 228393069, 228395303, 228397070, 228397160, 228397348, 228397783, 228386273, 228386396, 228388869, 228392960, 228397291, 228386273, 228388869, 228392960, 228397291, 228397336;
4) Units: 4228382636, 228383197, 228385919, 228386020, 228386266, 228386402, 228386417, 228389141, 228390449, 228390562, 228390590, 228392875, 228393061, 228393114, 228393124, 228393143, 228395235, 228395303, 228395395, 228397043, 228397422, 224682662, 228386020, 228386266, 228386402, 228386417, 228390562, 228393114, 228395270, 228395303, 228397043, 228397370, 224682603, 228386266, 228389141, 228390562, 228392873
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone and follow-up facsimile on October 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
NV, AZ
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1033-12
CODE
Unit: 6051124
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on March 9, 2006 and letter on March 15, 2006.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1047-12;
2) Recovered Plasma. Recall # B-1048-12
CODE
1) and 2) Unit: 8720222
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone or facsimile on October 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1089-12
CODE
Unit: 6028688
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on July 19, 2007 and follow-up letter dated July 23, 2007.
Manufacturer: Blood Centers of the Pacific, Ukiah, CA. 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
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1110-12
CODE
Unit: GR84113
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on August 31, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1140-12
CODE
Unit: W117011205185Y
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by facsimile on January 26, 2012.
Manufacturer: Blood Centers of the Pacific - Shasta Blood Center, Redding, CA. 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
Recovered Plasma. Recall # B-1141-12
CODE
Unit: W036510157983
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by electronic notification on February 2, 2012. 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
Source Plasma. Recall # B-1143-12
CODE
Units: 6010889586, 6010889163, 6010888221, 6010887464, 6010886500, 6010885848, 6010885014, 6010884308, 6010882963, 6010877733, 6010876935, 6010876066, 6010875503, 6010873132, 6010902768, 6010902196, 6010901296, 6010900278, 6010899631, 6010898726, 6010897718, 6010896946, 6010896382, 6010893581, 6010891145, 6010890608
RECALLING FIRM/MANUFACTURER
Biotest Pharmaceuticals Corp., San Antonio, TX, by facsimile on January 30, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
NC
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-1144-12
2) Red Blood Cells Leukocytes Reduced. Recall # B-1145-12;
3) Recovered Plasma. Recall # B-1146-12
CODE
1) Unit: W040711630172;
2) Units: W040711174326, W040711630172;
3) Unit: W040711174326
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone and facsimile on February 27, 2012. 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
4 units
DISTRIBUTION
IN
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1149-12
CODE
Unit: 06KS76273
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile on December 30, 2011 and by letter dated January 29, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Source Plasma. Recall # B-1150-12
CODE
Unit: 0080106710
RECALLING FIRM/MANUFACTURER
Biotest Pharmaceuticals Corp., Iowa City, IA, by e-mail on January 26, 2012. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning prior incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1153-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1154-12
CODE
1) Unit: 1638285;
2) Units: 1136203; 1136264; 1136326; 1165880; 1638285
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letters dated June 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Etodolac were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH, KY, FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1156-12;
2) Fresh Frozen Plasma. Recall # B-1157-12
CODE
1) and 2) Unit: 1629270
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated April 7, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, KY
PRODUCT
1) Red Blood Cells. Recall # B-1164-12;
2)Red Blood Cells Leukocytes Reduced. Recall # B-1165-12
CODE
1) Unit: V52976;
2) Unit: V49994
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated July 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1166-12;
2)Whole Blood Leukocytes Reduced. Recall # B-1167-12
CODE
1) Unit: 1620047;
2) Unit: 0890862
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated October 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1168-12;
2)Recovered Plasma. Recall # B-1169-12
CODE
1) and 2) Unit: 084J96590
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
PRODUCT
1) Plasma. Recall # B-1170-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1171-12
CODE
1) and 2) Units: 0857962; 0891897
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on March 16, 2005.
Manufacturer: Blood Center of the Pacific, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Switzerland
PRODUCT
1) Plasma. Recall # B-1173-12
2) Red Blood Cells Leukocytes Reduced. Recall # B-1174-12
CODE
1) and 2) Unit: 8202523
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1175-12
CODE
Unit: 6088609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by letter dated March 11, 2005.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Source Plasma. Recall # B-1185-12
CODE
Units: 04901351000, 04901345451, 04901310355, 04901295036, 04901288338, 04901237522, 04901219279, 04901201415, 04901249400, 04901178690, 04901105634, 04901080764, 04901276361, 04901260001, 04901242233, 04901188396, 04901168310, 04901112738, 04901087341
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Grand Prairie, TX, by electronic notification on January 19, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had an accidental needle stick, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
IL, Switzerland, Germany
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1195-12
CODE
Units; 2947603; 2938508
RECALLING FIRM/MANUFACTURER
Blood products, which were collected from a donor who traveled to a malaria endemic area, were distributed Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1196-12
CODE
Unit: 16KF56983
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone on July 3, 2007. Firm initiated recall is complete.
REASON
Blood product, not prepared in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Liquid Plasma. Recall # B-1297-12
CODE
Unit: W001311008388
RECALLING FIRM/MANUFACTURER
Department of Air Force – BB/HT, Lackland A F B, TX, by facsimile on February 27, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1299-12;
2) Fresh Frozen Plasma. Recall # B-1300-12
CODE
1) and 2) Unit: W1151120719219
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on February 23, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1025-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1026-12
CODE
1) 5565974, 5566450, 5567291, 5567784, 5568029, 5568250, 5568558, 5562947 (Bag 2), 5565974 (Bag 2), 5566450 (Bag 2), 5567291 (Bag 2), 5567784 (Bag 2), 5568156 (Bag 2), 5568250 (Bag 2), 5568563 (Bag 2), 5568799 (Bag 2);
2) Units: 5562949, 5564528, 5565698, 5566031, 5566427, 5567150, 5567267, 5567283, 5567297, 5568160, 5568161, 5568187, 5568215, 5568230, 5568242, 5568252, 5568266, 5568499, 5568565, 5568835, 5569034, 5569054, 5569073, 5569074, 5569076, 5569085
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on October 26, 2006. Firm initiated recall is complete.
REASON
Blood products, for which receipt temperature was not taken, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
NV
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1038-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-1039-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1040-12;
4) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1041-12;
5)Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1042-12
CODE
1) Units: 6630301, 6630671, 6631172, 6631207, 6631328, 6631342, 6631350, 6631455,8283414, 8301018, 8314637, 8306922, 8307191, 8307206,8708679,8282444, 8282465, 8283027, 8283287, 8301722, 8301728, 8301724, 8301730, 8301880, 8302120, 8302254, 8302614, 8303831, 6628214, 6628357, 8304628, 8306043, 6629676, 6629701, 6629780, 6629790, 6629786, 6629796, 8707536, 6630707, 6630919, 6631299, 6631322, 6631390, 8310473, 8310555, 8310573, 6632481, 6632469, 6632461, 8311023, 8311217, 8311490, 8300050, 8300775, 8300769, 8300767, 8300757, 8300777, 8300784, 8300791, 8032831, 8032836, 8300894, 8300900, 8300972, 8301052, 8301055, 8301354, 8033163, 8033150, 8302617, 8302955, 8302918, 6627628, 8033312, 8303433, 8303425, 6627931, 6627943, 8303838, 8303834, 8303835, 6628058, 6628081, 6628066, 6628057, 6628274, 6628358, 6628371, 6628366, 6628363, 6628374, 6628379, 8304626, 6628643, 6628625, 6628719, 6628725, 6628765, 6628747, 6628756, 6628749, 6628752, 8033780, 6628814, 6629114, 6629111, 8306038, 8306066, 8306015, 6629169, 6629192, 6629185, 6629195, 6629197, 6629188, 8306455, 8306457, 6629404, 6629460, 6629467, 6629470, 6629455, 6629497, 6629538, 6629543, 6629545, 6629553, 8306898, 8306894, 8306904, 8306900, 8306917, 8306912, 8306921, 8306923, 6629881, 8707321, 8707327, 8707324, 8307189, 8307186, 8307203, 8707518, 8707521, 8707526, 6630329, 8707537, 6630396, 6630561, 6630615, 6630702, 6630793, 8307910, 8307920, 8707721, 6630866, 8707735, 6630870, 6630872, 6630868, 6630941, 6630937, 8707858, 8282026, 8282318, 8283241, 8300770, 8300760, 8300782, 8300780, 8300792, 8301334, 8301355, 8301669, 8301672, 8302587, 6629405, 6629703, 8707325, 8707342, 8707352, 6629918, 6629956, 6630643, 6630714, 6631098, 6631370, 6631365, 8310286, 6630892, 6631387,6628076, 6628351, 6628745, 6628741, 8707410, 8282084, 8283274, 6628355, 6628369, 6629117, 8306012, 8306051, 8306046, 6629882, 6629883, 8707334, 8707428, 8707457, 6630235, 6630308, 6630614, 6631089, 6631398, 8309517, 8310053, 8310493, 8310919, 8311500, 6632868, 6632855, 8312766, 8282197, 8282283, 8282285, 8283272, 8283441, 8283649, 8283650, 8300131, 8300128, 8300130, 8300194, 8300215, 8300422, 8300903, 8300979, 8301422, 8301434, 8301447, 8302250, 8302247, 8033161, 8302599, 8302590, 8302584, 8302995, 8302991, 8303421, 6627939, 8303869, 8303890, 6628361, 6629161, 8707281, 6629390, 6629480, 6629679, 6629692, 6629776, 6629810, 6629868, 8707339, 6629919, 6629899, 8707355, 6630093, 8307207, 6630246, 6630255, 6630253, 6630322, 6630377, 6630709, 6630681, 6630704, 6630775, 8308648, 6631171, 6631333, 6631337, 6631324, 6631358, 8708021, 6631482, 6631549, 8309502, 8309535, 8309551, 8309571, 8310291, 8310265, 8310271, 8310277, 8310342, 6632458, 6632479, 6632471, 6632476, 6632561, 8310914, 8310917, 8311060, 8311201, 6632880, 6632872, 6632869, 8312025, 8312023, 6633022, 6633016, 8282076, 8282449, 8282451, 8282475, 8282796, 8282795, 8283134, 8283448, 8283636, 8283659, 8300055, 8300197, 8300217, 8300435, 8032823, 8032825, 8032824, 8301438, 8301443, 8302607, 6628054, 6628290, 6628758, 8306058, 8306071, 8306076, 6629178, 6629170, 6629206, 6629233, 6629248, 6629272, 6629307, 8306437, 6629393, 6629384, 6629398, 6629380, 6629411, 6629465, 6629555, 6629666, 6629694, 6629705, 6629709, 6629797, 8707336, 8707415, 6630067, 6630079, 8707409, 8307202, 6630228, 6630314, 6630557, 6630555, 6630948, 6631216, 6631215, 6631388, 6631381, 6631369, 6631410, 6631408, 6631489, 6631518, 8309428, 8309437, 6632575, 8035159, 8035163, 8035165, 8311021, 8311189, 8311198, 8311504, 8311611, 6632857, 6632852, 6632899, 6632897, 8312012, 8312034, 8708519, 6633009, 6633013, 6633046, 8708582, 6633144, 8708599, 8708585, 8282017, 8282078, 8282095, 8282194, 8282213, 8283311, 8283333, 8283444, 8283463, 8283459, 8283536, 8300207, 8300493, 8032840, 8301720, 8301732, 8302246, 8303245, 8303307, 6627934, 6628001, 8303827, 8303845, 8303843, 6628069, 8304404, 8304423, 8304427, 8304447, 8304467, 6628381, 8304640, 6628761, 6628824, 6628821, 8305933, 8306019, 6629176, 6629173, 6629250, 6629296, 8306473, 6629383, 6629493, 6629526, 6629541, 6629674, 6629678, 6629668, 6629716, 6629711, 6629719, 6629718, 6629767, 6629777, 6629789, 6629808, 6629811, 6629800, 6629809, 6629879, 6629896, 6629937, 6629930, 6629939, 6629944, 6629959, 6629970, 6629953, 6629971, 6629973, 6630085, 6630090, 8707429, 6630105, 6630144, 6630153, 6630230, 6630243, 6630242, 6630252, 6630306, 6630320, 6630359, 6630362, 8707538, 6630386, 6631184, 6631208, 6631212, 6631261, 8707963, 6631321, 6631361, 6631363, 6631425, 8708092, 8708100, 8708099, 8309449, 8309509, 8309536, 8309525, 8310315, 8310294, 8310322, 8310472, 6632451, 6632448, 8311185, 8311609, 8311612, 8311624, 8312020, 6633055, 8708553, 6633367,8312640, 8312629, 8312644,8312516, 8312553, 8282203, 8033782, 8312648;
2) Units: 8284382, 8300433, 8300902, 8303408, 8307884, 8283192, 8283213, 8302596, 8310492, 8303261, 8281906, 8283541, 8301350, 8301441, 8301588, 8303302, 8310569, 8282301, 8283025, 8283264, 8284335, 8300060, 8300450, 8032838, 8301457, 8283145, 8306116, 8307190, 8311631;
3) Units: 6633809, 6633825, 8312524, 8312565, 8312659, 8312670, 8708575, 8708598, 8312550, 8312562, 8312575, 6633692, 6633695, 6633804, 6633819, 6633817, 8312800, 6633321, 6633144, 6633121, 6633146, 6633154, 8312514, 8312680, 6633350, 6633373, 6633467, 6633466, 6633476, 6633496, 6633506, 6633491, 8708738, 6633701, 6633715, 8313517, 8313498, 8313529, 8313536, 6633801, 6633796, 6633788, 6633787, 6633784, 8312588, 8312601, 6633684, 6633709, 6633790, 6633123, 8312590, 8708731, 6633529, 6633689, 8312516, 8312574, 8312585, 8312824, 6633309, 6633306, 8708661, 8708665, 6633362, 6633367, 8708707, 6633503, 6633673, 6633773, 6633776, 6633781, 8708584, 8708583, 8708599, 6633165, 8312556, 8312553, 8312595, 8312592, 8312634, 8312638, 8312780, 6633305, 6633315, 6633323, 6633324, 6633341, 8708724, 6633489, 8708725, 8708732, 6633670, 6633676, 6633686, 6633714, 8313505, 8313515, 8313547, 8313567, 8313542, 6633814, 6633791, 6633812, 6633103, 6633105, 6633102, 8708582, 6633142, 6633148, 8708585, 6633155, 6633156, 8312518, 8312604, 8312649, 8312660, 8312678, 8312663, 8312806, 6633308, 6633304, 6633329, 6633320, 6633507, 8708760, 8708757, 6633678, 6633682, 8313509, 8313500, 8313504, 8313551, 6633778;
4) Unit: 8312656;
5) Units: 8312814, 8312828, 6633824, 8312803, 8312667, 8312667
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on February 29, 2008 and follow-up letter. Firm initiated recall is complete.
REASON
Blood products, for which documentation of temperature was unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE
827 units
DISTRIBUTION
CA, TX
PRODUCT
Double BPU 500 ML with CPD/Adsol, PL 146, RS-2000, Fenwal Express System, Product Code 4R3307E. Recall # B-1069-12
CODE
Lot # FM10F02019
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Lake Zurich, IL, by letter dated February 29, 2012.
Manufacturer: Fenwal International Inc., Maricao, PR. Firm initiated recall is ongoing.
REASON
Blood-Pack Unit Whole Blood Filter, Fenwal Express System in which the label for the satellite bag incorrectly identifies the product as whole blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9,500 units
DISTRIBUTION
VA, NB, NC, MN
PRODUCT
Double BPU 500 mL with CPD/Adsol Flex Excel Red Cell Filter, product Code 4R1582. Recall # B-1070-12
CODE
Lot Numbers: FM11E17034, FM11G11017, FM11G18012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Lake Zurich, IL, via telephone on February 29, 2012 followed by a letter.
Manufacturer: Fenwal International Inc., Maricao, PR. Firm initiated recall is ongoing.
REASON
Blood Pack Unit with Flex-Excel Red Cell Filter, in which the label for the red cell Storage bag incorrectly identifies the product as non-leukoreduced red cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50, 160 units
DISTRIBUTION
UT, KY, MO, NC, TX, NB, MI, OK, IL, MN, CA
PRODUCT
ADSOL Red Cell Preservation Solution System Brand Name: 4R3459 NDC# 0942-6445-03 NDA# 81-1104. Recall # B-1071-12
CODE
Lot FM11J03027
RECALLING FIRM/MANUFACTURER
Fenwal Inc., Lake Zurich, IL, by telephone and letter dated Feburary 29, 2012.
Manufacturer: Fenwal International, Inc., Marica, PR Firm initiated recall is ongoing.
REASON
Blood-Pack Units, in which the attached satellite bag was the PL-146 bag instead of the expected PL2209 plastic bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8,250 units
DISTRIBUTION
GA, IL, MN
PRODUCT
Product Code 4R1583 is a blood pack unit with an integral filter and is intended for leukocyte reduction of AS-1 Blood Cells. Recall # B-1072-12
CODE
Lot Number FM10J08050
RECALLING FIRM/MANUFACTURER
Fenwal International Inc., Maricao, PR, by telephone and letter dated February 29, 2012. Firm initiated recall is ongoing.
REASON
Blood-Pack Unit with Flex-Excel Red Cell Filter, in which the label for the whole blood collection container incorrectly identifies the contents as red cells leukoreduced.
VOLUME OF PRODUCT IN COMMERCE
6,680 units
DISTRIBUTION
FL, TX, OK
PRODUCT
Product is single dose vials of hepatitis B vaccine. Labeling reads in part: "***ENGERIX-B 20 mcg/mL NDC 58160-821-01***EACH mL CONTAINS 20 mcg OF HEPATITIS B SURFACE ANTIGEN ADSORBED ON 0.5 mg ALUMINUM AS ALUMINUM HYDROXIDE***STORE AT 36 - 46 F. SEE USP. DO NOT FREEZE***DIST. BY: GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, NC 27709 PRODUCT ID: CLEAR GLASS VIAL WHITE/BLACK/ORANGE/TEAL LABEL***NDC 58160-821-01***DISCARD IF FROZEN. Recall # B-1088-12
CODE
NDC 5816082101 (single dose vial); NDC 5816082111 (box of 10 vials).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Normed, Seattle, WA, by letters beginning June 16, 2011.
Manufacturer: Glaxo Smithkline – Rixensart, Rixensart, Belgium. FDA initiated recall is ongoing.
REASON
Engerix-B, lacking assurance of proper storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
240 vials
DISTRIBUTION
OR, UT, MO, AZ, LA, WA, CA
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1142-12
CODE
Unit: W091012117319 (2 units)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on February 1, 2012. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1147-12;
2)Recovered Plasma. Recall # B-1148-12
CODE
1) and 2) Unit: W040711139303
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone and facsimile on February 27, 2012. 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
2 units
DISTRIBUTION
IN
PRODUCT
1) Fresh Frozen Plasma (Apheresis). Recall # B-1151-12;
2) Cryoprecipitated AHF. Recall # B-1152-12
CODE
1) Units: W045111975112 ((2 units), W045111975327 (2 units), W045111974349 (3 units), W045111974489 (2 units);
2) Units: W045111317853, W045111262192, W045111241047, W045111241051, W045111241055, W045111241058, W045111241061, W045111245261, W045111240891, W045111241056, W045111241062, W045111241063, W045111241046, W045111241048, W045111241052, W045111241053, W045111241057, W045111241059
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by telephone on January 11, 2012 and by letter dated January 17, 2012. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within the required timeframe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
MO, AR
PRODUCT
Recovered Plasma. Recall # B-1155-12
CODE
Unit: 1094264
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letters dated June, 9, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Etodolac was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, KY, FL
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1172-12
CODE
Unit: FM37714
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile dated May 27, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using expired blood collection sets, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1187-12;
2) Whole Blood Leukocytes Reduced. Recall # B-1188-12
CODE
1) Units: 6087800; 6087802;
2) Units: 6087798; 6087803
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on February 28, 2005.
Manufacturer: Blood Centers of the Pacific, Ukiah, CA. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed. VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1197-12;
2) Recovered Plasma. Recall # B-1198-12
CODE
1) and 2) Unit: 084Q89633
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone and letter dated November 30, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving information concerning a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1199-12;
2)Plasma Frozen. Recall # B-1200-12
CODE
1) and 2) Unit: 084Z72809
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined subsequent to receiving post donation illness information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
PRODUCT
FastPlan Treatment Planning System, Model HZ3, Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software. Recall # Z-1217-2012
CODE
Code numbers: HZ30001 HZ30556 HZ32037 HZ33064 HZ30044 HZ30588 HZ32045 HZ36303 HZ30110 HZ30624 HZ32050 HZ37011 HZ30019 HZ30557 HZ32039 HZ35070 HZ30054 HZ30594 HZ32046 HZ37002 HZ30111 HZ30630 HZ32051 HZ37015 HZ30021 HZ30571 HZ32040 HZ36101 HZ30061 HZ30604 HZ32047 HZ37003 HZ30112 HZ30640 HZ32052 HZ37027 HZ30032 HZ30572 HZ32042 HZ36102 HZ30077 HZ30612 HZ32048 HZ37007 HZ30131 HZ30646 HZ32053 HZ37101 HZ30033 HZ30573 HZ32044 HZ36302 HZ30108 HZ30617 HZ32049 HZ37010 HZ30144 HZ30649 HZ32054 HZ38006 HZ30154 HZ30656 HZ32055 HZ38062 HZ30258 HZ30743 HZ32071 HZ30403 HZ32013 HZ33020 HZ30510 HZ32028 HZ33047 HZ30167 HZ30670 HZ32056 HZ39001 HZ30265 HZ30762 HZ32072 HZ30404 HZ32014 HZ33021 HZ30511 HZ32029 HZ33049 HZ30171 HZ30675 HZ32058 HZ39002 HZ30273 HZ32001 HZ32073 HZ30407 HZ32017 HZ33022 HZ30513 HZ32032 HZ33050 HZ30178 HZ30681 HZ32059 HZ39004 HZ30280 HZ32002 HZ32074 HZ30426 HZ32018 HZ33026 HZ30520 HZ32033 HZ33053 HZ30181 HZ30684 HZ32060 HZ39007 HZ30283 HZ32003 HZ32075 HZ30460 HZ32019 HZ33030 HZ30531 HZ32034 HZ33055 HZ30182 HZ30703 HZ32061 HZ39010 HZ30293 HZ32005 HZ32076 HZ30461 HZ32020 HZ33031 HZ30537 HZ32035 HZ33059 HZ30190 HZ30712 HZ32062 HZ39011 HZ30294 HZ32006 HZ32077 HZ30462 HZ32021 HZ33035 HZ30540 HZ32036 HZ33062 HZ30207 HZ30727 HZ32063 HZ39012 HZ30312 HZ32007 HZ32084 HZ30485 HZ32022 HZ33039 HZ30208 HZ30730 HZ32064 HZ39014 HZ30330 HZ32008 HZ32086 HZ30495 HZ32024 HZ33041 HZ30224 HZ30731 HZ32065 HZ39015 HZ30349 HZ32009 HZ32108 HZ30500 HZ32025 HZ33042 HZ30230 HZ30737 HZ32067 HZ39016 HZ30368 HZ32010 HZ32125 HZ30508 HZ32026 HZ33044 HZ30251 HZ30740 HZ32069 HZ39997 HZ30398 HZ32012 HZ32126 HZ30509 HZ32027 HZ33046
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on January 30, 2012. Firm initiated recall is ongoing.
REASON
An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result.
VOLUME OF PRODUCT IN COMMERCE
201 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator, a cannula, and a cannula obturator, which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management. Model # EGR 157, Part No.31-0040 and Model #EGR 138, Part No. 31-0138. Recall # Z-1226-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by letter on January 6, 2012.
Manufacturer: Integra LifeSciences Corp., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
The firm received several complaints from customers reporting that the blade of the EGR system may not retract back into the device following surgery. The firm attributes this problem to user error or improper surgical technique on the part of the physician.
VOLUME OF PRODUCT IN COMMERCE
850 units
DISTRIBUTION
Nationwide
PRODUCT
1) Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Recall # Z-1248-2012;
2) Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Recall # Z-1249-2012;
3) Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Recall # Z-1250-2012
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by
Manufacturers: Medtronic Europe Sarl, Tolochenaz, Switzerland;
Medtronic Puerto Rico Operations Co., Juncos, PR;
Arizona Device Manufacturer, Tempe, AZ. Firm initiated recall is ongoing.
REASON
A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage
VOLUME OF PRODUCT IN COMMERCE
68,804 devices
DISTRIBUTION
Nationwide and Internationally
PRODUCT
GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. Recall # Z-1399-2012
CODE
All associated serial numbers.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter December 23, 2911. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
Nationwide
PRODUCT
Clinical Chemistry Total Bilirubin, 6L45-20 & 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. Recall # Z-1425-2012
CODE
List Number (6L45-20) 64047HW00, 64048HW00, 65084HW00,65088HW00, 69001HW00, 69002HW00, 72016HW00,73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, List Number (6L45-40) 69025HW00, 73015HW00, 76038HW00, and 77015HW00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Inc., South Pasadena, CA, by letters bginning July 9, 2009. Firm initiated recall is complete.
REASON
A neonatal sample that was analyzed, produced results with values that were incorrectly less than the expected limit.
VOLUME OF PRODUCT IN COMMERCE
11,282 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728. Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system. Recall # Z-1439-2012
CODE
Lot 989520; Lot 850910 ; Lot 091250 Lot 429270
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter on March 15 2012. Firm initiated recall is ongoing.
REASON
Item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
NJ, TX, VA, MI IL, KT, PR and the Netherlands
PRODUCT
1) CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***ISO 9001-2008 Certified***Outstanding Value and Quality in Our Standard Care Cliner***Lower price does not mean lower quality when you buy a Winco Care Clinger. Our standard Care Cliner comes with all the superior features you might find on higher-priced clinical chairs.***KEY FEATURES***Standard head-rest cover***Padded armrests***Dual fold down side-tables***Removable side panels***Trendelenburg Positioning ***". Sticker with serial number is labeled in part: " *** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recall # Z-1457-2012;
2) CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features, plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift, making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning ***". Sticker with serial number is labeled in part: "*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recall # Z-1458-2012;
3) ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part: "***ELITE CARE CLINER 6900/6910***Winco***ISO 9001-2008 Certified***Design, comfort, durability, and value that exceed your expectations. ***Attention to detail and concern for comfort and quality, standards that Winco recliners are known for, places the Elite Care Cliner among the best-selling chairs on the market today. LiquiCell, an ultra-thin liquid filled interface that aids in reducing skin pressure, is standard for the Elite Care Cliner.***HEAT MASSAGE (Optional)***KEY FEATURES***Dual fold down tables***LiquiCell for added comfort***5â¬ï¿½ nylon total-lock casters***Built-in headrest***Headrest cover***". Sticker with serial number is labeled in part: "*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recall # Z-1459-2012;
4) ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms, allowing patients with limited mobility a modified entry. Also, LiquiCell has been added into the seat for extra comfort. This ultra-thin, liquid-filled interface aids in improved blood flow, and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***". Sticker with serial number is labeled in part: "*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recall # Z-1460-2012;
5) NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest*** The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it. Recall # Z-1461-2012
CODE
Chairs distributed between 04/01/2009 and 08/31/2009.
RECALLING FIRM/MANUFACTURER
Winco Mfg., LLC, Ocala, FL, by letter dated February 1, 2012. Firm initiated recall is ongoing.
REASON
There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this occur the wheel would come off and the chair would drop down 1.755". The caster horn would rest on the floor. If a caster comes off a chair it will tilt in the direction of the broken caster.
VOLUME OF PRODUCT IN COMMERCE
5132 casters (1592 chairs)
DISTRIBUTION
Nationwide, Canada and Singapore
PRODUCT
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system. Recall # Z-1462-2012
CODE
Lot #: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated March 27, 2012.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The monitor Ceiling suspension may fail, which may cause the monitor to drop.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump. Recall # Z-1463-2012
CODE
List Number 13027, all units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated March 28, 2012.
Manufacturers: Hospira Inc., Morgan Hill, CA;
Hospira Holdings de, Costa Rica Ltd., eal Cariari, Zona Franca Global
La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
VOLUME OF PRODUCT IN COMMERCE
47,127 cords - U.S. and 39,968 cords - ROW
DISTRIBUTION
Nationwide and Internationally
PRODUCT
UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed. Recall #Z-1475-2012
CODE
P10001 through P11500
RECALLING FIRM/MANUFACTURER
Stanley Security Solutions, Inc., Lincoln, NB, by letter dated December 8, 2011. Firm initiated recall is ongoing.
REASON
Monitor gives false alarms.
VOLUME OF PRODUCT IN COMMERCE
592 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite. Recall # Z-1477-2012
CODE
Lot: AL 041
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ogenix Corp., Beachwood, OH, by letter dated March 16, 2012.
Manufacturer: Sparton Medical Systems, Strongsville, OH. Firm initiated recall is ongoing.
REASON
Recall due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and Turkey
PRODUCT
1) Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead. Recall # Z-1482-2012;
2) Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead. Recall # Z-1483-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA,
REASON
Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
VOLUME OF PRODUCT IN COMMERCE
101,000 units total (59,000 units in US)
DISTRIBUTION
Nationwide and Internationally
END OF ENFORCEMENT REPORT FOR MAY 9, 2012