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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 27, 2011

 

April 27, 2011                                                                                        11-17
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Garden of Life***RAW Beyond Vitamins and Minerals***VITAMIN CODE***RAW VITAMIN C***High Potency RAW Formula with 300mg/500% DV of Vitamin C Live Probiotics and Enzymes***RAW, Vegan, Gluten Free, Dairy Free***60 UltraZorba Vegan Capsules***RAW Food Dietary Supplement***Suggested Use: Adults take two capsules daily. May be taken with or without food. Not intended for children. Capsules can be opened. Contents can be taken directly with water or raw juices. Supplement Facts***Serving Size 2 Capsules, Servings per Container 30***Vitamin C* 300mg, Calcium* 17 mg, Phosphorus* 23mg, RAW Probiotic and Enzyme Blend 100mg; UPC Code: 6 58010 11381 6. Recall # F-0956-2011
CODE
Lot Numbers: 0118AK898, 3550GK898, 6117KK898, 6117KK898A, 2444DJ898, 2444DJ898A, 0745BJ898, 0745BJ898A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Garden Of Life Inc., West Palm Beach, FL, by press release on March 2, 2011 and by letter on or about March 2, 2011.
Manufacturer: Nutra Manufacturing, Greenville, SC. Firm initiated recall is ongoing.
REASON
Garden Of Life, LLC is recalling all lots of Vitamin Code Raw Vitamin C distributed between June 2009 and January 2011. Product testing conducted by Garden of Life, LLC detected the presence of soy protein. People who have an allergy or severe sensitivity to soy may experience upset stomach, discomfort, and, in rare cases, serious and life threatening allergic reactions if they consume these products.
VOLUME OF PRODUCT IN COMMERCE
84,817 bottles
DISTRIBUTION
Nationwide, PR, China, Costa Rica, Dominican Republic, France, Germany, Great Britain, Guam, Indonesia, Jamaica, Netherlands, New Zealand, Nigeria, Saudi Arabia, Singapore, Sweden, Taiwan, Trinidad & Tobago
___________________________________
PRODUCT
Samlip Red Bean Bread, Net. Wt. 8.47 oz (240g) Keep Frozen UPC 8801068132175. Product of Korea. Recall # F-0957-2011
CODE
code ES 1120 and exp dates 8/15/2011, 9/30/2011, and 4/15/2011
RECALLING FIRM/MANUFACTURER
Seoul Shik Poom Inc., Englewood, NJ, by letters dated March 15, 2011 and by press release on March 22, 2011. Firm initiated recall is ongoing.
REASON
Red bean bread may contain undeclared egg based on NYSDAM sampling.
VOLUME OF PRODUCT IN COMMERCE
240 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Universal Gain Fast 3100 Vanilla Shake, 2.55 Plastic bottle, UPC 039442012159. Recall # F-0958-2011;
 
2) Universal LAVA Orange Slush, 2.75 lb. Plastic bottle, UPC 039442011503. Recall # F-0959-2011;
 
3) Universal Real Gains Chocolate Ice Cream, 6.85 lb Plastic bucket, UPC 039442011992. Recall # F-0960-2011;
 
4) Universal Super Whey Pro Vanilla, 1 lb, UPC 039442015945. Recall # F-0961-2011;
 
5) a) Universal Torrent Cherry Berry Blast , 3.28 lb plastic bottle, UPC 039442048141; b) Universal Torrent Cherry Berry Blast, 6.1 lb plastic bottle, UPC 039442048158. Recall # F-0962-2011;
 
6) a) Universal Torrent Green Apple Avalanche, 3.28 lb plastic bottle, UPC 039442048165; b) Universal Torrent Sour Citrus Rush, 6.1 lb plastic bottle, UPC 039442048196, Lot #180002 exp. date 2/9/2014. Recall # F-0963-2011;
 
7) Universal Torrent Ultra Mass 4500 Vanilla Shake, 9.3 lb plastic bottle, UPC 039442013507. Recall # F-0964-2011;
 
8) Universal Torrent Ultra Whey Pro Cookies & Cream, 5 lb plastic bottle, UPC 039442016126. Recall # F-0965-2011;
 
9) Universal Uni-Syn Strawberry 76 g packet, UPC 039442051783. Recall # F-0966-2011;
 
10) Universal Torrent Sour Citrus Rush, 6.1 lb plastic bottle, UPC 039442048196. Recall # F-0967-2011;
 
11) Universal Torrent Ultra Mass 4500 Chocolate Shake, 9.3 lb plastic bottle, UPC 039442013590. Recall # F-0968-2011
CODE
1) Lot #180104 exp. date 2/10/2014;
2) Lot #180013exp. date 2/10/2014
3) Lot #179922 A, B exp. date 2/01/2014;
4) Lot #179881 exp. date 2/01/2014;
5) a) Lot #180069 exp. date 2/09/2014; b) Lot #180071 exp. date 2/09/2014;
6) a) Lot #179883 exp. date 2/07/2014; b) Lot #180002 exp. date 2/9/2014;
7) Lot #180100B exp. date 2/9/2014;
8) Lot #179951 exp. date 2/7/2014;
9) Lot #179951 A, B, C exp. date Feb 2014;
10) Lot #180002 exp. date 2/9/2014;
11) Lot #180099B exp. date 2/10/2014
RECALLING FIRM/MANUFACTURER
Universal Protein Supplements Corp., New Brunswick, NJ, by press release dated March 18, 2011, and by letters on March 21, 2011. Firm initiated recall is ongoing.
REASON
Protein-based supplements are being recalled due to possible salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
27,834 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Portier Fine Foods Norwegian Smoked Salmon of various size packages including 4 oz., 8 oz., 16 oz. and random weight sides, labeled in part, "PORTIER FINE FOODS -- ALL NATURAL SMOKED SEAFOOD PRODUCTS -- STORE AT 38 F or Below". --- The product is vacuum packaged in clear plastic on a gold cardboard type tray. --- The product has "EXPIRES ON" date of 3/21 but since the product can be stored frozen; it may likely still be in consumers homes. Recall # F-0969-2011
CODE
Code 066 (represents the Julian date that the product was packaged, 3/07/11). The product was also labeled with an "EXPIRES ON" date of 3/21 (represents 3/21/11).
RECALLING FIRM/MANUFACTURER
The Smokehouse, LLC. d.b.a. La Maree Smokehouse, Mamaroneck, NY, by press release on March 30, 2011. FDA initiated recall is ongoing.
REASON
The product was found to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Approximately 200 lbs
DISTRIBUTION
NY, NJ, CT
___________________________________
PRODUCT
1) Assorted Cake 12 oz. and 24 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. One label is for each 12 oz. and 24 oz. sizes of the product. The packages for the 12 oz. products are labeled in part, Le Bon Patissier Assorted Cake Ingredients: Flour, Sugar, Honey, Margarine, Milk and Vanilla, Chocolate. Net wt. 12 oz. (340g).The packages for the 24 oz. products are labeled in part, Le Bon Patissier Assorted Cake Ingredients: Flour, Sugar, Honey, Margarine, Milk and Vanilla, Chocolate, Net wt. 24 oz. (340g); UPC 669038000125. Recall # 0972-2011;
 
2) Walnut Roll 14 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. The packages for the 14 oz. products are labeled in part, Le Bon Patissier Walnut Roll Ingredients: Flour, Sugar, Honey, Margarine, Milk and Vanilla. Net wt 14 oz. (398g); UPC 669038006134. Recall # F-0975-2011;
 
3) French Cookies 12 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. The packages for the 12 oz. products are labeled in part, Le Bon Patissier French Cookies***Ingredients: Sugar, Honey, Egg Powder, Margarine, Walnut, Vanilla. Net wt 12 oz. (341g); UPC 669038419026. Recall # F-0976-2011;
 
4) Nazook 12 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached; UPC 669038000033. The packages for the 32 oz. products are labeled in part, Le Bon Patissier Cranberry Cake***Ingredients: Wheat Flour (All Purpose Flour), Bleached Malted Barley, Niacin, Iron, Thiamine Mononitrate, (Vitamin B1) Riboflavin, Folic Acid), Margarine, (Margarine-Gold-N-Sweet, Unsalted Vegetable Oil), Sour Cream, Sugar, Dry Yeast, Salt, Vanilla***32 oz.  Recall # F-0977-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Le Bon Patisserie-2, Inc. dba Le Bon Patissier, La Crescenta, CA, by letter on March 31, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because Le Bon Patissier was alerted that their Assorted Cake, Napoleon, Day & Night cake, Walnut roll, French Cookies, Honey Cake, Bird Milk and Nazook cakes have been manufactured with undeclared labeling of eggs, milk, walnuts, pistachios, almonds, and wheat. These undeclared products are allergens and can pose a significant health hazard to those with known allergies who consume these products. Walnut Roll products contain undeclared egg, walnut, and wheat that are not listed in the ingredients.
VOLUME OF PRODUCT IN COMMERCE
185 boxes
DISTRIBUTION
CA
___________________________________
PRODUCT   
Gagan Turmeric Powder packaged in a plastic bag, net wt. 200 gram. The retail package has a UPC 775620311064. The product is labeled in part: "GAGAN HALDI POWDER TURMERIC POWDER***Net Wt. 200 g***PRODUCT OF INDIA. The master case has a batch number TE/10-11/BG-03. Recall # F-0980-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recall Firm: Punjab Trading Inc., Auburn, WA, by telephone on February 8, 2011 and visits between February 8 – 15, 2011  
Manufacturer: Karan International Ltd., Chandigarh, India. Firm initiated recall is ongoing.
REASON
The Turmeric powder imported from Canada was contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
169/200 gram packages
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Bake Lotus Seed Moon Cake, 8oz, Labeled as: "MAI'S BAKERY ***Nhung Sen Trang ***". UPC code: 850660001479. F-0981-2011;
 
2) Bake Red Bean Moon Cake, 8oz, Labeled as: "MAI'S BAKERY ***Nhung Dau Do ***"; UPC code: 850660001479.Recall # F-0982-2011;
 
3) Bake Mung Bean Moon Cake, 8oz, Labeled as: "MAI'S BAKERY ***Nhung Dau Xanh ***"; UPC code: 850660001479. Recall # F-0983-2011;
 
4) Hopia Mongo Durian Bean Cake, 6 oz, Labeled as: "MAI'S BAKERY ***Banh Bia Sau Rieng ***"; UPC code: 850660000137. Recall # F-0984-2011;
 
5) Hopia Mongo Taro Cake, 6 oz, Labeled as: "MAI'S BAKERY ***Banh Bia Nhan Mon***" UPC code: 850660000137. Recall # F-0985-2011;
 
6) Hopia Mongo Mung Bean Cake, 6 oz, Labeled as: "MAI'S BAKERY ***Banh Bia Dau Xanh Bi***" UPC code: 850660000137. Recall # F-0986-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Mai's Bakery, Corp., Monterey Park, CA, by press release on March 24, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because Hopia Mongo and Moon Cake products from Mai's Bakery contains undeclared eggs and soybean oil.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA and UT
___________________________________
PRODUCT
Del Monte Cantaloupes. Packaged in 4 plastic beige mesh sleeves each sealed with a plastic orange handle with the Del Monte Logo and indicating "3 count, Product of Guatemala" Shipping Cartons are dark brown cardboard with the "Del Monte" logo in red lettering and "cantaloupes" in yellow lettering on a green background. Costco Header: Side One: ***Eat Healthy, Live Healthy***Del Monte Quality***cantaloupes*** Side Two: 3 count Product of Guatemala. The cantaloupes were sold in a 3 count beige mesh sleeve with a plastic orange handle with the Del Monte Logo. Cantaloupes were offered for sale between March 10th and 21st of 2011. Recall # F-0987-2011
CODE
Lot Codes: 02-15-24-10, 02-15-25-10, 02-15-16-10 and 02-15-28-10.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Del Monte Fresh Produce N.A., Inc., Miami, FL, by press release on March 22, 2011.
Manufacturer: PRODUCTOS AGRICOLAS DE ORIENTE S.A., Estanzuela, Guatemala. Florida State initiated recall is ongoing.
REASON
Cantaloupes have the potential to be contaminated with Salmonella Panama.
VOLUME OF PRODUCT IN COMMERCE
4,992 cartons
DISTRIBUTION
WA, CA, AZ, TX, and UT
___________________________________
PRODUCT
1) Hazelnuts sold as: Sunripe "Large" brand, 1 lb, Sell By Date: 6/30/11, UPC Code: 070533 000167; George Packing brand, 50 lb. Recall # F-0988-2011;
 
2) Mixed Nuts containing hazelnuts sold as: Sunripe brand, 1 lb, Sell By Date: 6/30/11, UPC Code:070533 000143; Sunripe brand, 2 lb, Sell By Date: 6/30/11, UPC Code:070533 001003; Sold as Season's Greetings Gift Pack, 4 lb, Sell By Date: 6/30/11, UPC Code: 070533 101024; Sunripe Imperial brand, 50 lb; Sunripe Supreme brand, 50 lb. Recall # F-0989-2011
CODE
1) Sell By Date: 6/30/11 (Only 1 lb bag labeled with Sell By Date);
2) Sell By Date: 6/30/11 (50 lb bags were not labeled with a Sell By Date)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Defranco And Sons, Inc., Los Angeles, CA, by press release on March 4, and March 5, 2011 and by letter via fax beginning on March 5, 2011 and March 16, 2011/  
Manufacturer: George Packing Company, Inc., Newberg, OR. FDA initiated recall is ongoing.
REASON
The recall was initiated because the listed hazelnut and mixed nut products containing hazelnuts may be contaminated with Escherichia coli O157:H7 bacteria (E. coli O157:H7).
VOLUME OF PRODUCT IN COMMERCE
140,059 lbs
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Frozen SCDA (fish) -- Net wt.: 400g (14 oz) -- UPC 0 809042 168163. The product is sold in a vacuum packed plastic bag. Recall # F-0993-2011
CODE
Code 111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hua Shing International Trading Corp., New York, NY, press release and letters on February 16, 2011. New York initiated recall is complete.
Manufacturer:UNKNOWN
REASON
The imported processed fish was found to be not properly eviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
147 cartons (30 x 400 grams bags per carton)
DISTRIBUTION
NY City
___________________________________
PRODUCT   
The product is a processed dried fish imported from China. The recalled Dried Fish comes in an unmarked cardboard box. Each fish is approximately 7-7.5 inches in length. The fish is sold in bulk form or may be repacked into clear unlabeled, uncoded plastic bags. Recall # F-0994-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: WH & Group, LLC., Brooklyn, NY, by press release on February 17, 2011 and by letter dated February 17, 2011.  
Manufacturer: Lingshui Quanxing Foodstuff Manufacturing Co., Ltd., Xincun Town, Lingshui County, Hainan Province, China. New York initiated recall is complete.
REASON
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1 case (approximately 50 fish x 200 grams)
DISTRIBUTION
NY State
___________________________________
PRODUCT   
Angelina Smoked Round Scad (Gulaunggong) Butterfly Cut, 8oz. Packaging description: Product packaged in a clear vacuum-packed, synthetic plastic bag, sealed at the top with a blue and yellow cardboard label with black and red printing that reads on the front, Angelina***SMOKED ROUNDSCAD (GALUNGGONG)***KEEP FROZEN NET WT. 8 OZ. (227 G) Ingredients: Fresh RoundScad and Salt To be cooked before eating The back panel is white with black printing and reads, Nutrition Facts. UPC 0 77396 14311 6 (not limited to this UPC; Packages after Jan 2011 has this UPC code & it is in compliance). Recall # F-0995-2011
CODE
Packages after Jan 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arko Foods Int'l Inc., Los Angeles, CA, by letter on March 30, 2011.
Manufacturer: Arko Foods Phils, Inc., Valenzuela City, Philippines. Firm initiated recall is ongoing.
REASON
The Angelina Smoked Round Scad (Gulaunggong) Butterfly cut is over 5" long and is uneviscerated, and it has the potential to be contaminated with Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
1264 cartons (40pk/ct, 8oz/pk)
DISTRIBUTION
CA, NV, WA, AZ, UT, MD, IL, TX, OR, MO, IA, CO, VI, FL, ID, GA
___________________________________
PRODUCT   
1) Whey-26, Strawberry (all sizes) sold under the following brand names: Vitalabs, Inc. Ultra Whey-26 Strawberry & Cr�me 420 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26031 1; Vitalabs, Inc. Ultra Whey-26 Strawberry & Cr�me 840 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26032 8; Vitalabs, Inc. Ultra Whey-26 Strawberry & Cr�me 2270 Gram Plastic Buckets Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26033 5 and YourHCG.Com Whey Protein Strawberry 420 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013. Recall # F-0997-2011;
 
2) Whey -26, Vanilla (all sizes) sold under the following brand names: Donne Hales Whey-26 Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013; Dr. Bills Choice Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; HCG Buy Direct Whey-26 Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; The Healthy Way Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 00002 3; The Healthy Way Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 00001 6; Iron Mag Labs Whey Isolate Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 01101 2; Len Rossis Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Len Rossis Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Natures Pantry Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Natures Pantry Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 29503 0; Northeast Ohio Endocrinology Whey Protein Powder Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Nutrition World Ultra Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 30116 8; Nutrition World Ultra Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 30215 8; Nutrition World Ultra Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 29916 8; Peachtree Natural Foods Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 85631 6; Peachtree Natural Foods Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 85611 8; Sharp Labs G Booster Plus Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Susans Essential Formulas Daily Whey Isolate Protein 26 Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 7 05105 70551 4; This Is Bio Shape Shake Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 48479 3; Trainers Choice Ultra Whey 26 Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Trainers Choice Ultra Whey 26 Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013; Unlimited Nutrition Athletic Protein Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013; Vitalabs, Inc. Ultra Whey-26 French Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26011 3; Vitalabs, Inc. Ultra Whey-26 French Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Vitalabs, Inc. Ultra Whey-26 French Vanilla 2270 Gram Plastic Buckets Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26013 7; Vitalabs, Inc. Ultra Whey-26 French Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26011 3; Vitalabs, Inc. Ultra Whey-26 French Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Vitalabs, Inc. Ultra Whey-26 French Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26013 7; YourHCG.Com Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 and YourHCG.Com Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013. Recall # F-0998-2011;
 
3) Whey - 26, Chocolate (all sizes) sold under the following brand names: Dr. Bills Choice Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; HCG Buy Direct Whey-26 Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; The Healthy Way Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00004 7; The Healthy Way Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00003 0; Innovative Nutra Labs Nutrapure Whey Protein Isolate Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00011 7; Iron Mag Labs Whey Isolate Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 01101 2; Iron Mag Labs Whey Isolate Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 01102 9; Lifestyle Perfect Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; Natures Pantry Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26021 2; Natures Pantry Whey Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26022 9; Northeast Ohio Endocrinology Whey Protein Powder Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; Peachtree Natural Foods Whey Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 85622 4; Peachtree Natural Foods Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 85612 5; SouthFit Supplements Whey To Go Chocolate 2270 Gram Plastic Buckets Lot # 3477 with Exp. Date 01-2013; Team Kattouf Whey Boost Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 50301 2; Trainers Choice Ultra Whey 26 Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013, UPC Code 0 92617 24678 0; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26021 2; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26022 9; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 2270 Gram Plastic Buckets Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26023 6; X3 Nutrition X3 Whey 26 Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 and YourHCG.Com Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477. Recall # F-0999-2011
CODE
1) Lot number: 3364;
2) Lot numbers: 10131 and 3477;
3) Lot number: 3477 with Exp. Date 01-2013
RECALLING FIRM/MANUFACTURER
Vitalabs, Inc., Jonesboro, GA, by letter on/about March 4, 2011 and by press release on March 10, 2011. FDA initiated recall is ongoing.  
REASON
The product was manufactured using whey protein product recalled by Bongards Creameries, due to possible Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
5,484 lbs
DISTRIBUTION
AL, AR, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, UT, WA, Aruba, Canada and Poland
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Day & Night 14 oz. and 32 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. One label is for both sizes of the product and a check box is marked to identify the weight of the product. The packages are labeled in part, Le Bon Patissier Day & Night Ingredients: Flour, Sugar, Honey, Eggs, Margarine, Milk, Vanilla, Net wt., 14 oz. (398g), 30 oz. (851g); UPC 669038000118. Recall # F-0970-2011;
 
2) Napoleon 14 oz. and 30 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. One label is for each 14 oz. and 30 oz. sizes of the product. The packages for the 14 oz. products are labeled in part, Le Bon Patissier Napoleon Ingredients: Flour, Sugar, Eggs, Margarine, Vanilla, Milk. Net Wt. 14 oz. (398g). The packages for the 30 oz. products are labeled in part, Le Bon Patissier Napoleon Ingredients: Flour, Sugar, Eggs, Margarine, Vanilla, Milk, Net wt. 30 oz. (851g); UPC 669038010018. Recall # F-0971-2011;
 
3) Bird Milk 14 oz. and 24 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. One label is for each 14 oz. and 24 oz. sizes of the product. The packages for the 14 oz. products are labeled in part, Le Bon Patissier Bird Milk Ingredients: Flour, Sugar, Honey, Eggs, Margarine, Milk, Vanilla and Chocolate, Net wt. 14 oz. (398g). The packages for the 24 oz. products are labeled in part, Le Bon Patissier Bird Milk Ingredients: Flour, Sugar, Honey, Eggs, Margarine, Milk, Vanilla and Chocolate, Net wt. 24 oz. Recall # F-0973-2011;
 
4) Honey Cake 24 oz. Product comes packaged in clear plastic snap containers with red, white and blue labels attached. The packages for the 24 oz. products are labeled in part, Le Bon Patissier Honey Cake:  Ingredients: Flour, Sugar, Honey, Eggs, Margarine, Milk and Vanilla. Net wt. 24 oz; UPC 669038000323. Recall # F-0974-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Le Bon Patisserie-2, Inc. dba Le Bon Patissier, La Crescenta, CA, by letter on March 31, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because Le Bon Patissier was alerted that their Assorted Cake, Napoleon, Day & Night cake, Walnut roll, French Cookies, Honey Cake, Bird Milk and Nazook cakes have been manufactured with undeclared labeling of eggs, milk, walnuts, pistachios, almonds, and wheat. These undeclared products are allergens and can pose a significant health hazard to those with known allergies who consume these products. Walnut Roll products contain undeclared egg, walnut, and wheat that are not listed in the ingredients.
VOLUME OF PRODUCT IN COMMERCE
24 boxes
DISTRIBUTION
CA
___________________________________
PRODUCT   
Lemon Pound Cake, Net wt. 32 ozs (737G), UPC Code 6 8602220003 3. Recall # F-0990-2011
CODE
Lot numbers: 00111 thru 07411
RECALLING FIRM/MANUFACTURER
Crenshaw Enterprises dba Butcher & Baker, Memphis, TN, by telephone on March 18, 2001 and by letter dated March 22, 2011. FDA initiated recall is ongoing.
REASON
Undeclared Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
152 cases
DISTRIBUTION
MS
___________________________________
PRODUCT   
1) Gulabjamun, Soft Dumplings Flavoured with Cardamom in Sugar Syrup, 35.30 oz (1kg), UPC 9299170139. Recall # F-0991-2011;
 
2) Rasgulla, Soft Dumplings in Rose Flavored Sugar Syrup, 35.30 oz (1kg), Spicy World; UPC 9299170138. Recall # F-0992-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spicy World USA, Houston, TX, by letter beginning December 10, 2011.  
Manufacturer: Good-Day Foods Ltd., Thane, India. FDA initiated recall is ongoing.
REASON
Product contains undeclared wheat flour..
VOLUME OF PRODUCT IN COMMERCE
310 cases
DISTRIBUTION
TX, NM
___________________________________
PRODUCT   
Anny's Love is Our Main Ingredient Orange Cookie***Kosher Pas Yisroel***Ingredients; Unbleached and Unbromated Flour, Vegetable Margarine (Liquid and Partially Hydrogenated Soybean Oil, Soy Lecithin, Vegetable Mono & Diglycerides, Sodium Benzoate, Natural & Artificial Flavor, Bet Carotene (Color), Vitamin A Palmitate Added, Eggs, citric Acid, Xantham Gum, Vanilla Extract, Sea Salt, Baking Powder, Orange Flavor, Fruit Jam.***Net wt: 10 oz. UPC 1 98466 00132 3***Manufactured in a facility that uses nuts.*** Product is packaged in clear non-flexible plastic containers with black, red, white, and orange printed lettering. Recall # F-0996-2011
CODE
Sell by Date: 031411 to 040411
RECALLING FIRM/MANUFACTURER
Heara Inc., Miami, FL, by visit on March 9, 2011. FDA initiated recall is ongoing.
REASON
The product labeling on the Orange Cookie did not list wheat as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Southeast FL
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT   
1) RE DualVit Plus, Ferrous Fumarate/Polysaccharide Iron Vitamin-Mineral Complex Capsules, 90 Capsules, NDC 68032-242-90, Rx Only. Recall # F-0978-2011;
 
2) REocyte Plus, Iron-Vitamin-Mineral Complex Capsules, 100 Capsules, Rx only, NDC # 68032-239-10. Recall # F-0979-2011
CODE
1) and 2) Lot number: OJ3259, Exp. 10/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: River's Edge Pharmaceuticals, LLC, Suwanee, GA, by email on/about December 16, 2010.
Manufacturer: PureTek Corporation, San Fernando, CA. Firm initiated recall is ongoing.
REASON
The bottle labeled as REocyte Plus may contain a different capsule, RE DualVit Plus, which lacks magnesium. The multipart label may contain information for both capsules on the same bottle.
VOLUME OF PRODUCT IN COMMERCE
2,364 units
DISTRIBUTION
AL, AR, AZ, FL, GA, KY, LA, MO, MD, NC, NJ, OH, OK, PA, SC, TN, TX and VA
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT   
Diovan� (valsartan) 160 mg, 7000 Tablets, NOVARTIS label, Rx only; NDC 0078-0359-17. Recall # D-438-2011
CODE
Lot F0976, Exp. DEC 2013
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY, by letters dated March 16, 2011. Firm initiated recall is ongoing.
REASON
Adulterated: presence of foreign tablets; a bottle of Diovan 160mg tablets was found to contain some tablets identified as Diovan� HCT 320/12.5mg
VOLUME OF PRODUCT IN COMMERCE
278 bottles of 7000 bottles
DISTRIBUTION
NJ, NV
___________________________________
PRODUCT
Chlorzoxazone Tablets USP 500 mg, Rx only, 100 Tablets. Recall # D-440-2011
CODE
Lot number 314134 exp 12/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, byletter via FedEx on November 16, 2010.
Manufacturer: Barr Laboratories, Inc. (div. Of Teva), Forest, VA. Firm initiated recall is ongoing.  
REASON
Adulterated Presence of Foreign Tablets: Isoniazid residue found in bottle of Chlorzoxazone tablets.
VOLUME OF PRODUCT IN COMMERCE
9,435 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Levothyroxine Sodium Tablets USP, 150 mcg (0.15 mg), 100 Tablets (10 x 10), NDC 51079-445-20, (Packaged in blister packs, 10 tablets/card, 10 cards/package). Recall # D-441-2011
CODE
Lot OA432, Expiration Date: 04/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL, by letter dated February 23, 2011.
Manufacture: Mylan Pharmaceuticals Inc., Morgantown, WV. Firm initiated recall is complete.
REASON
Subpotent (Single Ingredient) Drug: Pharmaceutical did not meet assay specification.
VOLUME OF PRODUCT IN COMMERCE
2,004 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Humira (adalimumab) Pen, 40 mg/0.8mL, 2 single-use prefilled pens, for subcutaneous use only, Rx only, NDC 0074-4339-02 carton, UPC 3 00744 33902. Recall # D-443-2011
CODE
Lot 92078LJ40, Exp JUL 2012 and Lot 93085LX40, Exp AUG 2012
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letters dated March 18, 2011. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; some of the Humira Pen Cartons may contain damaged pens which are unusable and may potentially expose a user to broken pieces of glass.
VOLUME OF PRODUCT IN COMMERCE
80,128 cartons
DISTRIBUTION
Nationwide, including PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT   
Mirtazapine Tablets, USP 45 mg, 30 Tablet Bottles; Rx only. NDC 13107-032-30. Recall # D-442-2011
CODE
Lot Number: 032090003A Exp. date 04/2011 032090011A, 032090009A, Exp. date: 10/2011; Lot Number: 032100006A, Exp. date: 12/2011; Lot Number: 032100012A, Exp. date: 2/2012; Lot Number: 032100019B, Exp. date: 04/12; Lot Number: 032100021A, 032100021B, 032100022A, 032100022B, Exp. date: 06/2012; Lot Number: 032100025A, Exp. date: 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurobindo Pharmaceutical USA, Inc., Dayton, NJ, by letters via email dated February 24, 2011 
Manufacturer: Aurolife Pharma LLC, Dayton, NJ. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Recall initiated due to the product not meeting a specification for a known degradation product during routine stability tasting.
VOLUME OF PRODUCT IN COMMERCE
66,915 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg per capsule, 60 Capsules (10 Blister strips of 6) with 1 Aerolizer Inhaler per carton, Rx only, NDC 0085-1401-01, UPC 3 0085-1401-01 9. Recall # D-444-2011
CODE
Lot F0008, Exp 04/12
RECALLING FIRM/MANUFACTURER
Recalling Firm:Novartis Pharmaceuticals Corp. Suffern, NY, by letter on March 10, 2011.
Manufacturer: Novartis Pharma Stein AG, Stei, Switzerland ;
Novartis Pharmaceuticals Corp., Suffern, NY.
Firm Initiated recall is ongoing.
REASON
Out Of Specification Particle Size Distribution Test: During recent testing of Foradil Aerolizer Lot F0008 an out of specification (OOS) result was reported for the Particle Size Distribution Test.
VOLUME OF PRODUCT IN COMMERCE
62,323 cartons
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0017-11
CODE
Unit: W086510003037
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by electronic mail on January 9, 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
IN
___________________________________
PRODUCT
Source Plasma. Recall # B-0781-11
CODE
Unit:07LWIG5594
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on January 17, 2008. 
Manufacturer: BioLife Plasma Services, L.P., Onalaska, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-0925-11
CODE
Unit: W04251001161508
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by telephone on March 18, 2011. Firm initiated recall is complete.
REASON
Blood product, incorrectly determined to be negative for the Jka antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
___________________________________
PRODUCT   
Source Plasma. Recall # B-0926-11
CODE
Unit: 4590109438
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Jacksonville, FL, by e-mail on February 9, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical examination was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1191-11
CODE
Units: W091010316680, W091010316705
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on February 12, 2011 and by facsimile on March 16, 2011.
Manufacturer: Oklahoma Blood Institute, Hot Springs, AR. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1192-11
CODE
Unit: 35FX54584
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by electronic notification on February 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1193-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1194-11
CODE
1) Units: W120610231911, W120610282769, W120610272238;
2) Units:W120610382566, W120610382139
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on February 14, 2011 and March 4, 2011. 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
5 units
DISTRIBUTION
MI
___________________________________
PRODUCT   
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1195-11;
2) Fresh Frozen Plasma. Recall # B-1196-11;
3) Red Blood Cells. Recall # B-1197-11;
4) Red Blood Cells Leukocytes Reduced. Recall # B-1198-11;
5) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1199-11 
CODE
1) Units: 7239847 (Parts 1, 2, & 3), 7220471 (Parts 1 & 2), 7083214 (Parts 1 & 2), 7081915 (Parts 1, 2, & 3), 7050408 (Parts 1 & 2), 6434245 (Parts 1, 2, & 3), 6390005 (Parts 1, 2, & 3)
 
2) Units: 1292837, 5463472, 6202066;
3) Units: 5347398, 5463472;
4) Unit: 6202066;
5) Unit:1292837
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone and facsimile on August 28, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the human immunodeficiency virus (HIV), but were collected from a donor who was previously deferred for testing reactive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units   
DISTRIBUTION
NJ, NY, Switzerland
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1205-11
CODE
Unit: W071810006928
RECALLING FIRM/MANUFACTURER
So CA Permanente Med Group Blood Donor Center, Downey, CA, by fax and letter on March 9, 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1207-11
CODE
Unit: 17GN47168
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax and e-mail on September 23, 2007. 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
MN, IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1211-11
CODE
Units:17FQ12013; 17FQ12027; 17FQ12027; 17FQ12020; 17FQ12020; 17FQ12020; 17FQ12013
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by letter dated November 15, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced which did not meet the QC requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma. Recall # B-1212-11
CODE
Unit:08LWIB5812
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax, on June 3, 2008.   
Manufacturer: BioLife Plasma Services, L.P., Onalaska, WI. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT   
1) Cryoprecipitated AHF. Recall # B-1220-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1221-11 
CODE
1) and 2) Unit: 12FP12772
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter and fax on February 23, 2011 and follow up letter on March 7, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, PR, NC
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1224-11 
2) Plasma Frozen. Recall # B-1225-11
CODE
1) and 2) Unit: 12Y89626
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 3, 2008 and by letter dated August 26, 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
NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-1226-11
CODE
Unit: 0490657771
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by e-mail on August 13, 2008.
Manufacturer: CSL Plasma, Inc., Grand Prairie, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1227-11
CODE
Unit: 8255679
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email on January 13, 2011 and January 21, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1229-11
CODE
Unit: W036510029868
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by electronic notification on March 8, 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 Leukocytes Reduced. Recall # B-1230-11
CODE
Unit: 024KG92010
RECALLING FIRM/MANUFACTURER
American National Red Cross, River Valley Region, Louisville, KY, by facsimile on February 10, 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
IN, CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1200-11
CODE
Units: 5347398, 5401866
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone and facsimile on August 28, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the human immunodeficiency virus (HIV), but were collected from a donor who was previously deferred for testing reactive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, NY, Switzerland
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1206-11
CODE
Unit: 009FX50615
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB, by fax on February 10, 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
Nationwide
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1208-11
CODE
Unit: 17GN47168
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax and e-mail on September 23, 2007. 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
MN, IL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1209-11;
2) Recovered Plasma. Recall # B-1210-11
CODE
1) and 2) Unit: W067111018931
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by fax on March 28, 2011 and follow up letter dated April 6, 2011, and via the internet on March 29, 2011. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor whose arm inspection documentation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, LA
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1219-11 
CODE
Unit: 12FP12772
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter and fax on February 23, 2011 and follow up letter on March 7, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. 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
CA, PR, NC
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1222-11
CODE
Unit: LG17707
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on April 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Fresh Frozen Plasma (Apheresis) Irradiated. Recall # B-1223-11
CODE
Unit: FM03994
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on May 24, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1228-11
CODE
Units: W065610041380; W065610041388
RECALLING FIRM/MANUFACTURER
Bergen Community Region Blood Center, Paramus, NJ, by telephone on August 13, 2008 and December 2, 2010 and by follow-up fax on December 10, 2010. Firm initiated recall is complete.  
REASON
Blood products, which failed to meet the minimum specifications for red blood cell percent recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1231-11
CODE
Unit: 024KG92010
RECALLING FIRM/MANUFACTURER
American National Red Cross, River Valley Region, Louisville, KY, by facsimile on February 10, 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
IN, CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT   
Penumbra brand Penumbra Coil System, Penumbra Coil 400. The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Micro catheter. Recall # Z-1906-2011
CODE
Units: F17211, F17212, F17213, F17214, F17215, F17216, F17256, F17257, F17258, F17259, F17260, F17310, F17311, F17333, F17334, F17335, F17336, F17337, F17338, F17339, F17340, F17374, F17375, F17376, F17395, F17396, F17397, F17398, F17399, F17400, F17401, F17402, F17403, F17404, F17405, F17440, F17441, F17442, F17443, F17444, F17445, F17446, F17447, F17448, F17485, F17486, F17487, F17489, F17507, F17511, F17512, F17513, F17514, F17515, F17516, F17517, F17564, F17565, F17566, F17567, F17568, F17569, F17668, F17669, F17670, F17672, F17673, F17675, F17676, F17705, F17706, F17707, F17708, F17710, F17735, F17736, F17737, F17738, F17739, F17740, F17741, F17742, F17743, F17744, F17745, F17780, F17781, F17782, F17783, F17790, F17791, F17792, F17793, F17794, F17833, F17834, F17835, F17836, F17837, F17838, F17839, F17840, F17841, F17842, F17843, F17844, F17900, F17901, F17902, F17903, F17904, F17905, F17906, F17907, F17908, F17924, F17925, F17926, F17927, F17928 , F17929, F17930, F17931, F17932, F17933, F17934, F17935, F17936, F17966, F17967, F17968, F17969, F17970, F17971, F17972, F17973, F17974, F17975, F17976, F17977, F17999, F18000, F18001, F18002, F18021, F18022, F18023, F18024, F18041, F18042, F18043, F18044, F18045, F18046, F18047, F18066, F18068, F18073, F18074, F18075, F18076, F18090, F18091, F18092, F18093, F18094, F18121, F18122, F18123, F18124, F18125, F18126, F18127, F18128, F18129, F18146, F18147, F18148, F18149, F18150, F18151, F18152, F18153, F18179, F18180, F18181, F18182, F18183, F18184, F18185, F18186, F18194, F18195, F18196, F18197, F18231, F18232, F18233, F18234, F18235, F18236, F18239, F18240, F18241, F18242, F18243, F18244, F18245, F18246, F18247, F18248, F18249, F18291, F18292, F18293, F18294, F18295, F18307, F18308, F18309, F18336, F18337, F18338, F18373, F18374, F18375, F18387, F18388, F18389, F18400, F18401, F18415, F18416, F18417, F18449, F18450, F18451, F18457, F18458, F18459, F18460, F18461, F18479, F18480, F18481, F18482, F18483, F18484, F18485, F18486, F18487, F18488, F18513, F18514, F18515, F18516, F18517, F18518, F18519, F18520, F18521, F18550, F18551, F18552, F18553
RECALLING FIRM/MANUFACTURER
Penumbra Inc., Alameda, CA, by letter dated March 3, 2011. Firm initiated recall is complete.
REASON
The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
VOLUME OF PRODUCT IN COMMERCE
2,082 units
DISTRIBUTION
Nationwide and Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom, Switzerland and South Africa
___________________________________
PRODUCT
1) DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management. Recall #Z-1946-2011;
 
2) DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management. Recall # Z-1947-2011;
 
3) DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management. Z-1948-2011
CODE
1) Lot Codes: 1060792 1060824 1060841 1060851 BBBA0953D BBBA0953E BBBA0953F BBBA0953G BBBA1001T BBBA1001V BBBA1002H BBBA1002I BBBA1005D BBBA1005E BBBA1005F BBBA1005G BBBA1007J BBBA1008C BBBA1008E BBBA1010G BBBA1010H BBBA1010J BBBA1010K BBBA1012B BBBA1012C BBBA1012E BBBA1014A BBBA1014E BBBA1015F BBBA1015G BBBA1018E BBBA1018F BBBA1020B BBBA1020C;
 
2) Lot Codes: 1060790 BBBA1001N BBBA1005C BBBA1006G BBBA1014C;
 
3) Lot Codes: 1060789 1060823 1060838 1060848 1061291 1061292 BBBA1001I BBBA1003D BBBA1003E BBBA1004A BBBA1006F BBBA1007D BBBA1008A BBBA1010A BBBA1011D BBBA1014B BBBA1015R BBBA1018G BBBA1019E
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, letter dated December 2, 2010.  
Manufacturer: COFAT, LA MARSA, Tunisia. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to breach in sterile packaging.
VOLUME OF PRODUCT IN COMMERCE
12,144 units
DISTRIBUTION
Nationwide, United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia
___________________________________
PRODUCT
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism. Recall # Z-1949-2011
CODE
Lot Numbers (s): All reagent pack lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated March 20, 2011.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm to the fetus/neonate.
VOLUME OF PRODUCT IN COMMERCE
151,740 units
DISTRIBUTION
Nationwide and Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, and Zambia
___________________________________
PRODUCT   
ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. Recall #Z-1952-2011
CODE
Lot Numbers: W100166, WI00167, W100168
RECALLING FIRM/MANUFACTURER
ArthroCare Corp., Sunnyvale, CA, by letters on September 30, 2011. Firm initiated recall is ongoing.
REASON
During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
VOLUME OF PRODUCT IN COMMERCE
170 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. Model number H83. Recall # Z-1957-2011
CODE
Code numbers: H834994 H831143 H834351 H836061 H836419 H837299 H834232 H833905 H836845 H836831 H833652 H831103 H834028 H834384 H838435 H837941 H834080 H834147 H836754 H837672 H838121 H836761 H834732 H837811 H837802 H837657 H837295 H837819 H836445 H837817 H837931 H831807 H834079 H831502 H837382 H836685 H838446 H836128 H837015 H837685 H837694 H837935 H833956 H836763 H838114 H837684 H836447 H837943 H834977 H837656 H836275 H838445 H837945 H837928 H836336 H837357 H837502 H837942 H837820 H837651 H838119 H838106 H833954 H837413 H837693 H838433 H837934 H831512 H836269 H838112 H838120 H838437 H838122 H838108 H836106 H838441 H833955 H838113 H836657 H833856 H837814 H837696 H837933 H837816 H837927 H838556 H834417 H838118 H837807 H834662 H837031 H836087 H837650 H837374 H833354 H833343 H836489 H831418 H833813 H834449 H836406 H833247 H833326 H831611 H833146 H834603 H831158 H833348 H832715 H831032 H834125 H833635 H831980 H831074 H833882 H831230 H834866 H834929 H834991 H834469 H831971 H836430 H833176 H833606 H834912 H833869 H834554 H837146 H832728 H834192 H836492 H836776 H836777 H831234 H834731 H833952 H834786 H831197 H831652 H833816 H836323 H834919 H833972 H833971 H834752 H837058 H834260 H834230 H836454 H831098 H836321 H834270 H833668 H836277 H834747 H831048 H836490 H833951 H834424 H836113 H836293 H833953 H834283 H832916 H836402 H831296 H831097 H836766 H837544 H833974 H833658 H836453 H833950 H836471 H833158 H834451 H836170 H836481 H836506 H836003 H836298 H834193 H836524 H836404 H836168 H837314 H832393 H836066 H834736 H833538 H836069 H834008 H836823 H834009 H834477 H836007 H833551 H834124 H831898 H837042 H833429 H834470 H834889 H833142 H834196 H833693 H833556 H836118 H832653 H836176 H834934 H831325 H838115 H834405 H833772 H833445 H834138 H836779 H833585 H831055 H837949 H832902 H834186 H834488 H836095 H836332 H833577 H833755 H833741 H834967 H834369 H834483 H836281 H833843 H834769 H836986 H833853 H833701 H832771 H832602 H833638 H833715 H833391 H833318 H837024 H832000 H836642 H832713 H836972 H834355 H833868 H837289 H833957 H834127 H832872 H834564 H832710 H831221 H831724 H831932 H832870 H832335 H836347 H834588 H834972 H833221 H831994 H836758 H831714 H836593 H833680 H833682 H831130 H831437 H831875R1 H836595 H836199 H836167 H832608M H834813 H832950R2 H834095 H834409A1 H833924 H833071 H833369R1 H834762 H831198 H832536 H836522 H833027 H833681 H832084 H836424 H833399 H831711A4 H832608R1 H831124 H831639 H834293 H834353 H834490 H834394 H833091 H836687 H832847 H834031 H832950M H833458 H832830M H831446 H833433 H834948 H834737 H831835 H832969R3 H837018 H834568 H831803 H832351 H831185 H836311 H832297 H831252R2 H833404 H837072 H832423 H833904 H832969M H832969R2 H836650 H832741M H834000 H836485 H836283 H832181 H836322 H831052 H832436 H832618 H831190M H831252M H831252R1 H833552 H836686 H836848 H834491 H832358M H832358R3 H832830R1 H832358R2 H833672 H831876 H832969R1 H834869 H836109 H834399 H833329 H834462 H832982 H832950R1 H833684 H834255 H833993 H833126 H833902 H831875M H833686 H833369M H834887 H834979 H832593 H834189 H831839 H834198 H836079 H832583 H833249 H833995A1 H837007 H832741R1 H832561 H834789 H831019 H834456A1 H832594 H834663 H831279 H832755 H831113 H832358R1 H836096 H831452 H833946 H833259 H837016 H834456A4 H832698 H834022 H831305 H833825 H834958 H836124 H834881 H831190R1 H836292 H833570 H831559 H832167 H833402 H833370 H833934 H836093 H836111 H833557
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on February 7, 2011. Firm initiated recall is ongoing.
REASON
An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.
VOLUME OF PRODUCT IN COMMERCE
421 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17. Recall # Z-1958-2011
CODE
Serial Numbers: 1961, 2127, 2260, 239446, 239446, 240619, 241535, 242384, 242711, 242862, 244489, 244502, 244530, 244977, 245874, 246275, 246526, 247557, 247813, 247976, 248040, 248871, 249015, 249235, 249238, 249441, 249784, 218756C, 2250, 2251, 240126, 240126A , 240605, 240605A, 240605B, 240605C, 240605D, 240605E, 241379, 241379A, 241379B, 242154J, 242154K, 242154L, 245767, 245767F, 246769, 246769A , 247199AE, 247199AJ, 248129F, 248321, 248321A, 248378C, 248824, and 248824A
RECALLING FIRM/MANUFACTURER
Dental Equipment LLC, Newberg, OR,  by letter on March 8, 2011. Firm initiated recall is ongoing.
REASON
Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
VOLUME OF PRODUCT IN COMMERCE
55 chairs and 11 units of accessories
DISTRIBUTION
Nationwide, Australia, Canada, Ireland, South Africa, and Vietnam
___________________________________
PRODUCT   
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records. Part numbers 8149259, 8164787, 8166527. Recall # Z-1970-2011
CODE
Versions 8.3, CD# 9, 10 and 11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated September 8, 2010.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is complete.  
REASON
When editing the note type of a previously entered note, then reverting to the original type, data may be lost.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
DE, WI, TX, TN, NJ, PA, NE, MA, AL and South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan
 
___________________________________
PRODUCT   
1) SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. Recall # Z-1981-2011;
 
2) SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD. Recall # Z-1982-2011
CODE
1) Lot numbers: 1051003, 11051004, 11051005, 1052004, 10052005, 11052006, 1053002, and 1054002;
 
2) Lot numbers: 1011004, 11011005, 1012004, 11012005, 11012006, 11012007, 11012008, 11042002, 11042003, 11014002, and 11044001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hsmg, Inc., D/b/a Smartinfuser USA, Houston, TX, by e-mail and telephone on March 17, 2010.
Manufacturer: Medical Flow Systems, Ltd, Shlomi, Israel. Firm initiated recall is ongoing.
REASON
Elastomeric tube in product's compression unit has the potential to burst following filling.
VOLUME OF PRODUCT IN COMMERCE
1,851 pumps
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Magnetom Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging. Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. Recall # Z-2021-2011
CODE
Serial numbers 30265, 30204, 35108, 30646, 35020, 25297, 30125, 30234, 30435, 30385, 26326, 30317, 30476, 35258, 30019, 30130, 30035, 30851, 30475, 30759, 26182, 30833, 25635, 30162, 25998, 35227, 30153, 35012, 30226, 30028, 30380, 30045, 30202, 25300, 25880, 30108, 25758, 30799, 30616, 30767, 30940, 26213, 30426, 27213, 35161, 31089, 25492, 26566, 35299, 25242, 25293, 30504, 35330, 30454, 30233, 30338, 30529, 30208, 30740, 30482, 30472, 30383, 26425, 30364, 30499, 30275, 30834, 26698, 30254, 26223, 26329, 30124, 30512, 30166, 30410, 26553, 25409, 35015, 26900, 30602, 30957, 30144, 30780, 30896, 30239, 30839, 30250, 30298, 30083, 30730, 30986, 30367, 30109, 35064, 30225, 31000, 30857, 30440, 30012, 30350, 35318, 35319, 35321, 26491, 30471, 30242, 30948, 30337, 30392, 30582, 30058, 35403, 25911, 30938, 30474, 30732, 27641, 30601, 25134, 35259, 25717, 25420, 20600, 27633, 35111, 26364, 30391, 27175, 25154, 25424, 30056, 30742, 26194, 30959, 30300, 30830, 30353, 30777, 30201, 35312, 35311, 26504, 30887, 27260, 30958, 31033, 35176, 30238, 30176, 35077, 30652, 35408, 27101, 30273, 35222, 30925, 30090, 25852, 30272, 25230, 30032, 25264, 35152, 25991, 30066, 25286, 31001, 26016, 26272, 30753, 27013, 30224, 30720, 35380, 30607, 30633, 31015, 35010, 25215, 25427, 25962, 27505, 30783, 26077, 30112, 31039, 25316, 35364, 26230, 27157, 25716, 30627, 26145, 30039, 30346, 25054, 26358, 35235, 35182, 26031, 35201, 25948, 30255, 35008, 35014, 25069, 25408, 26657, 26953, 27162, 25931, 26252, 27156, 25063, 26827, 26088, 25672, 25179, 25976, 25114, 25893, 25395, 30689, 30569, 30402, 25888, 30650, 25552, 25231, 30811, 30539, 30705, 30059, 30960, 30982, 35261, 35029, 25389, 25730, 25768, 26856, 30656, 30137, 30628, 30591, 35050, 30017, 30249, 30132, 30782, 35351, 26726, 25678, 30180, 30622, 27316, 25905, 25582, 25166, 30597, 30992, 25921, 25551, 25491, 30388, 25310, 30481, 30256, 30401, 30647, 26465, 27051, 25651, 30791, 30635, 25818, 26187, 30552, 26668, 35348, 30468, 30452, 30348, 25507, 30962, 27079, 26762, 26764, 30424, 30119, 25576, 30549, 26359, 31094, 30111, 30161, 30880, 30846, 30291, 30347, 30187, 30015, 30453, 30478, 25680, 30614, 30040, 25404, 25484, 27306, 26114, 26121, 25807, 30072, 35163, 30590, 30837, 26436, 30524, 35046, 26244, 27707, 25445, 35125, 30542, 35110, 25108, 30550, 30838, 30441, 35221, 30422, 30803, 35398, 30506, 35167, 25429, 25292, 30443, 30534, 30596, 25663, 25992, 27019, 25352, 25386, 35025, 26356, 31020, 25505, 30564, 30528, 30386, 25207, 26141, 25438, 25444, 26360, 30357, 25960, 26311, 26280, 30670, 26792, 25025, 30770, 26171, 25993, 25525, 30360, 30488, 25145, 30613, 30972, 30733, 30662, 30985, 25307, 25364, 30570, 25682, 30171, 35172, 25977, 30258, 30771, 27376, 30036, 30487, 30723, 30598, 30370, 30044, 30316, 30247, 31074, 25523, 35052, 25489, 26591, 26062, 26653, 30175, 30669, 31013, 25459, 25785, 30868, 30618, 26287, 26383, 30800, 30459, 27252, 35186, 26078, 30758, 30089, 30553, 25572, 30810, 26779, 35389, 30376, 25796, 35358, 26281, 30557, 30793, 30879, 31072, 25175, 26224, 35323, 27347, 30750, 26446, 35250, 30467, 30522, 26665, 30408, 30375, 30991, 35240, 30115, 30561, 26619, 30721, 31023, 30145, 25877, 30587, 30866, 35157, 30063, 30359, 30182, 30711, 26398, 26888, 30743, 26217, 25967, 26897, 27426, 25696, 25196, 30345, 25763, 25041, 30497, 26617, 30136, 30122, 30207, 35160, 30014, 30438, 30381, 30491, 30844, 31046, 30304, 30823, 30935, 30719, 30910, 30832, 30623, 30462, 30445, 31084, 31049, 30068, 35062, 25058, 35043, 30076, 30968, 25520, 25771, 30362, 26168, 30295, 30685, 27177, 26442, 26649, 27451, 30369, 30663, 27366, 31036, 30054, 30503, 30544, 30530, 30749, 30966, 30460, 27180, 60600, 30738, 25978, 25985, 30287, 30817, 35192, 35236, 25497, 26269, 30798, 31012, 30448, 30518, 31059, 25203, 30220, 30593, 30069, 25332, 30565, 30904, 30951, 25720, 26945, 26785, 34144, 31041, 30463, 30080, 30179, 30413, 25105, 30520, 30021, 26881, 30029, 26621, 30065, 30071, 25927, 30407, 30061, 30248, 30509, 26533, 26400, 30227, 35280, 35281, 25104, 31092, 35317, 25337, 26053, 35180, 30169, 30197, 30211, 31098, 30319, 30067, 25460, 27344, 30915, 30661, 30559, 25606, 30320, 30423, 30870, 26126, 35115, 30451, 35101, 35288, 35022, 25157, 26039, 30005, 30082, 25581, 25973, 26051, 266227, 30525, 25533, 25411, 25817, 25558, 35070, 26399, 35023, 30563, 30271, 30043, 30210, 25021, 30206, 30378, 30536, 35307, 30228, 25610, 30632, 26966, 26449, 30680, 31065, 26938, 30146, 30170, 25044, 30676, 30297, 30765, 26080, 35074, 26423, 30994, 30703, 25284, 26397, 31008, 26435, 26870, 27059, 30447, 25077, 26286, 27179, 25926, 30264, 30638, 30763, 35428, 35066, 25822, 30643, 25322, 25384, 26846, 25875, 25126, 27161, 30241, 30989, 30548, 35164, 27053, 35141, 30936, 26963, 30398, 25152, 30185, 30515, 35162, 35006, 25096, 30588, 35238, 27054, 30787, 30049, 26992, 25225, 30490, 35295, 30806, 30232, 30342, 30864, 30523, 30074, 30577, 25550, 25957, 25358, 30340, 25701, 30675, 25249, 30824, 30368, 30414, 27467, 30876, 35007, 25036, 25727, 25952, 30581, 30277, 30639, 30668, 30366, 30142, 30621, 20587, 27297, 30748, 30216, 30775, 25470, 30025, 26255, 26418, 30425, 30430, 30404, 25146, 30400, 30924, 35104, 30814, 30470, 35390, 30308, 25135, 26216, 26704, 31034, 30592, 30148, 30756, 26620, 26193, 30869, 25454, 30075, 31005, 30917, 30953, 30975, 30943, 30918, 30946, 25783, 25797, 35279, 25030, 35001, 20591, 25010, 25403, 30786, 35423, 30263, 30651, 31060, 31053, 30096, 25910, 27354, 30872, 30094, 25594, 30952, 30768, 30150, 30269, 26373, 35187, 26692, 30789, 26350, 31018, 25352, 26241, 30997, 25174, 30349, 30305, 26454, 30106, 30389, 30508, 35427, 35013, 25023, 26461, 27324, 30726, 30828, 27471, 26052, 35075, 25792, 25949, 30326, 25383, 26957, 27040, 30507, 27194, 31067, 30095, 30510, 25274, 30713, 30047, 30167, 30871, 30728, 30081, 30855, 27204, 30023, 26325, 30266, 30302, 30103, 35271, 35139, 30289, 35078, 30100, 30543, 30862, 30858, 30235, 30406, 25527, 30697, 30151, 35136, 35131, 31086, 27244, 30437, 25477, 30325, 30708, 30154, 30363, 30978, 30874, 30617, 30784, 35385, 26804, 30585, 30664, 30667, 30578, 26011, 27293, 31083, 30160, 30261, 30428, 25372, 30725, 30631, 30558, 30343, 30772, 30377, 35393, 30746, 30502, 30418, 25530, 26489, 26590, 26723, 30229, 30849, 35212, 30473, 26486, 26333, 25903, 30282, 25342, 30446, 25412, 30236, 30630, 26670, 26546, 35048, 26370, 30484, 27100, 30055, 30433, 30379, 30129, 30555, 26627, 30306, 30571, 25961, 30020, 30114, 30116, 25180, 25305, 25690, 30009, 25185, 26004, 30458, 30717, 25919, 30744, 30107, 30541, 30371, 25123, 30533, 25614, 26314, 30745, 30580, 31104, 30214, 25980, 26319, 25684, 27534, 30361, 30033, 30231, 26048, 26130, 26628, 30949, 30673, 30138m 27046, 30575, 26371, 35191, 25435, 30140, 26927, 27198, 25833, 35026, 30629, 25479, 26021, 30535, 30046, 30477, 30854, 25247, 31022, 30152, 30372, 25537, 27253, 30091, 27099, 31341, 30684, 30358, 35011, 26064, 30420, 35243, 26568, 26959, 25216, 26808, 26427, 27443, 30276, 30479, 30773, 35297, 26243, 25958, 35264, 30373, 26559, 30223, 35324, 30956, 30781, 30434, 30605, 35168, 30609, 30149, 30642, 30027, 30262, 30988, 30159, 30042, 26075, 35005, 35171, 25150, 35019, 30945, 31100, 30483, 25772, 30526, 30164, 25222, 30415, 26462, 27620, 27557, 30030, 25164, 27004, 25093, 30566, 26835, 30419, 30092, 30158, 30974, 30449, 25644, 27381, 30034, 30057, 26037, 25815, 30574, 30230, 30314, 26159, 35284, 26148, 26178, 30163, 30268, 30352, 25485, 30399, 26284, 30053, 25382, 30022, 26276, 25374, 25837, 25298, 27207, 27714, 25899, 30812, 25074, 25946, 26662, 30270, 31087, 25078, 27033, 30313, 30501, 25155, 26026, 30365, 27330, 35290, 30498, 26532, 25509, 27222, 30239, 30356, 25240, 30155, 31071, 30779, 35018, 25718, 26689, 31097, 35184, 35045, 27102, 35188, 30253, 25070, 25767, 26560, 30191, 30301, 35153, 26615, 25436, 30198, 26155, 25528, 20573, 25248, 30442, 27201, 25430, 26956, 30267, 27088, 27066, 25959, 25038, 30916, 30290, 25705, 30064, 35241, 30084, 30190, 30037, 30395, 25046, 26469, 30296, 30604, 25372, 30665, 30344, 26018, 31032, 30293, 25087, 35344, 26569, 30845, 31014, 25033, 26451, 30060, 35365, 25245, 26219, 30396, 35445, 30240, 30024, 26885, 30931, 25681, 30456, 30485, 30822, 25707, 30625, 25086, 35357, 25362, 25625, 25694, 30041, 25024, 35230, 30279, 26452, 30004, 30311, 31080, 30085, 35328, 26320, 35343, 35003, 25016, 35260, 25212, 27595, 35426, 30141, 25969, 30843, 25511, 26191, 30079, 30480, 26575, 30411, 30829, 35412, 25140, 25106, 26550, 27230, 30836, 30118, 27122, 35035, 35030, 25712, 26109, 25611, 35273, 25052, 30086, 30809, 35257, 27049, 30196, 30178, 30769, 35114, 25347, 35229, 35068, 35044, 25963, 26811, 35053, 30653, 35267, 35024, 25706, 25870, 27214, 25029, 30121, 30671, 35072, 35142, 25233, 25776, 35021, 30429, 35338, 25320, 35335, 35069, 30194, 35154, 25886, 35067, 35039, 25198, 30165, 35327, 35061, 30427, 30128, 35263, 35017, 25820, 35313, 26564, 35228, 25360, 31006, 25457, 30382, 25725, 25047, 30551, 30595, 30692, 25539, 25580, 25654, 26396, 26421, 27358, 30120, 30200, 26751, 30143, 30937, 30831, 35216, 35217, 35073, 30193, 27050, 25814, 30942, 30412, 30516, 30734, 30825, 30848, 30941, 31021, 31056, 35291, 35418, 25350, 25381, 25667, 25675, 26054, 26248, 26492, 26608, 26652, 26787, 26893, 27221, 27258, 27412, 26424, 30299, 30436, 30666, 30674, 30928, 25508, 26648, 26781, 26962, 30926, 30990, 26214, 20616, 26852, 30374, 25453, 30173, 25144, 26125, 26535, 30221, 27637, 30243, 35443, 35439, 35444, 30619, 25232, 26192, 30556, 30213, 25065, 25432, 30710, 25734, 30469, 30511, 26972, 30354, 25103, 25956, 30658, 35177, 35248, 26321, 30283, 25912, 35415, 30922, 30192, 30310, 31025, 26747, 25510, 30126, 30612, 25390, 25197, 30390, 30626, 35155, 26614, 27172, 30199, 30881, 35174, 25800, 25540, 30339, 30724, 25693, 30955, 26132, 30186, 25816, 30659, 31052, 26937, 30038, 30246, 25609, 30093, 30464, 26998, 30774, 27224, 30785, 27026, 35407, 35071, 35076, 30123, 30203, 30281, 30387, 30409, and 30181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated November 24, 2010,
Manufacturer: Siemens Medical Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
VOLUME OF PRODUCT IN COMMERCE
1,419 units
DISTRIBUTION
District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY (every State except VT) 
___________________________________
PRODUCT
Siemens brand 550 TxT Patient Treatment Table, part number 7346534; The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques. Recall # Z-2023-2011
CODE
All units of Listing Number: R864406
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated March 21, 2010.  
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
VOLUME OF PRODUCT IN COMMERCE
326 units
DISTRIBUTION
NJ, WI, NY, and MA
___________________________________
PRODUCT   
1) Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. Recall # Z-2040-2011;
 
2) Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901. Recall # Z-2041-2011
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Gendex Dental Systems, Des Plaines, IL, by letter on February 4, 2011. Firm initiated recall is ongoing.
REASON
There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes
VOLUME OF PRODUCT IN COMMERCE
6, 835 units
DISTRIBUTION
Nationwide, Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam
___________________________________
PRODUCT   
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system. Catalog # PH-09806. Recall # Z-2048-2011
CODE
Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA, by letter dated March 25, 2011. Firm initiated recall is ongoing.
REASON
Labeling discrepancy: The outer corrugate as well as a card inside the package state the product contains dry natural rubber – this is not duplicated on the unit packaging.
VOLUME OF PRODUCT IN COMMERCE
840 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1): Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, a vascular necrosis or traumatic arthritis. Recall # Z-2053-2011;
 
2) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1). Recall # Z-2054-2011;
 
3) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1). Recall # Z-2055-2011;
 
4) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1). Recall # Z-2056-2011;
 
5) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1). Recall # Z-2057-2011;
 
6) R3 TM CERAMIC ACETABULAR LINER, BIOLOX� FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1). Recall # Z-2058-2011
CODE
1) Units: 09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252;
 
2) Units: 09FT32385, 09FT32566, 09GT34366, 09GT34367, and 09HT34777;
 
3) Units: 09FT32383, 09FT32504, 09GT33518, 09GT33519, 09GT33918, 09GT33919, 09GT34111, 09GT34112, 09KT36378, and 09MT38082;
 
4) Units: 09BT29050, 09BT29051, 09BT29052, 09BT29053, 09CT29212, 09CT29213, 09DT30919, 09DT303920, 09DT31160, 09DT31161, 09DT31162, 09FT32751, 09GT33613, 09GT34388, 09KT36368, and 09KT36369;
 
5) Units: 09DT30917, 09ET31916, 09ET31977, 09FT32386, 09FT32854, 09GT33389, 09GT33893, 09GT33894, 09HT34767, 09HT34768, 09HT34769, and 09JT35381;
 
6) Unit:09JT35383
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis, TN, by e-mail and letter on March 11, 2011.
Manufacturer: Smith & Nephew, Tuttlingen, Germany. FDA initiated recall is ongoing.
REASON
During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.
VOLUME OF PRODUCT IN COMMERCE
865 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Purina Tank Topper 18% Pellets, sold in bulk. Recall # V-120-2011
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Land O'Lakes Purina Feed LLC, Lubbock, TX, by visit on July 24, 2010. Firm initiated recall is complete.
REASON
Bulk Feed Protein level above acceptable limit.
VOLUME OF PRODUCT IN COMMERCE
48,420 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
Hartz Naturals Real Beef Treats for Dogs, Small; 8 oz package; packaged in a plastic bag. UPC number 32700-11519. Recall # V-121-2011
CODE
Lot Code BZ0969101E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hartz Mountain Corp., Secaucus, NJ, by press release, telephone and e-mail on September 3, 2010, and by letters on September 7, 2010 and September 10, 2010.
Manufacturer: JBS SA, Sao Paulo, Brazil. FDA initiated recall is complete.  
REASON
Natural Real Beef Treats for Dogs may have been potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
56,058 bags
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT   
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500. Recall # V-122-2011
CODE
Parent SN FCC06380013SA FCC06380032SA FCC06380039SA FCC07040117SA 8136918 FCC06430060SA FCC10420113SA FCC07050057SA FCC07140040SA FCC07070058SA FCC07020024SA FCC06430029SA FCC06230063SA FCC06310007SA FCC06310008SA FCCJ00672 FCC06370043SA FCC06370045SA FCC06340088SA FCC06420052SA FCE06360005SA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated March 30, 2011.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware that the plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
NC, CA, WI, TX, CT, OR, LA, MT,  Netherlands
___________________________________
PRODUCT   
1) Veterinary Concepts Canine Collection A/I Kit Product No: 19250, Canine Semen Collection and A.I. Kit. Recall # V-123-2011;
 
2) 1) Creative Pet Products, Horse Aid, First Aid Kit for Horses, Model # 10140 2) Creative Pet Products, Sporting Doc, First Aid Kit For Dogs, Premium Kit, Model # 10145. 3) Creative Pet Products, Sporting Dog II, First Aid Kit for Dogs, Portable Field Kit, Model # 10148. 4) K9 First Aid Kit, Police & Military, Model # 10151. Recall # V-124-2011
CODE
1) Lot numbers beginning with 07, 08, 09 and 10;
2) None
RECALLING FIRM/MANUFACTURER
Recalling Firm: MAI / Genesis, Elmwood, WI, by letters dated March 3, 2011 and March 9, 2011.
Manufacturers: MAI / Genesis, Elmwood, WI;
Creative Pet Products, Spring Valley, WI.
Firm initiated recall is ongoing.
REASON
MAI/Genesis is voluntary recalling kits which contain a sterile lubricant jelly pack and/or alcohol prep pad manufactured by TRIAD Group in Hartland, Wisconsin. The TRIAD Group has issued a recall of these items due to concerns about potential contamination with Bacillus cereus and concerns due to the validation of the gamma radiation sterilization cycle. This recall impact the kits produced by MAI/Genesis (Veterinary Concepts) and Creative Pet Products.
VOLUME OF PRODUCT IN COMMERCE
7,750 kits
DISTRIBUTION
AL, AZ, AR, CA, CO, CT, FL, GA, ID, KS, LA, MA, MI, MN, MS, MO, MT, NE, NH, NY, NC, ND, OH, OK, PA, SC, SD, TX, UT, WI. Taiwan, Australia, United Kingdom, Costa Rica
 
END OF ENFORCEMENT REPORT FOR APRIL 27, 2011
 
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