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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 1, 2011

 

June 1, 2011                                                                                        11-22
 
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Waco's BESTYETT Sandwiches Made Fresh Daily CHICKEN SALAD ON BREAD $2.25 Ingredients Homestyle Chicken Salad: Salad Dressing, Cooked Dark Chicken Meat, Celery, Cooked Chicken, Pickle Relish (Pickles, Water, Corn Syrup, Distilled Vinegar, Salt, Modified Food Starch, Sodium Benzoate [A Preservative], Alum, Spice, Natural Spice Flavors, FD&C Yellow #4, Polysorbate 80), Onions, Red Peppers, Water, Breadcrumbs, (Bleached Wheat Flour, Dextrose, Salt, Yeast), Salt, Soybean Oil, Modified Food Starch, Glucono-Delta Lactone, Spices, Chicken Base (Chicken Including Natural Chicken Juices, Salt, Chicken Fat, Sugar, Maltodextrin [From Corn], Hydrolyzed Vegetable Protein, Whey, Natural Flavorings, Yeast Extract, Turmeric), Xanthan Gum, Titanium Dioxide, Citric Acid. BREAD: Flour, Water, Corn Syrup, Nonfat Milk. Contains less than 2% of each of the following: Partially Hydrogenated Soy beal Oil, Salt, Yeast, Mono and Diglycerides, Calcium Steoroyl-2-Lactylate, Calcium Sulfate, Malted Barley, Calcium Propiate (To Retard Spoilage), Corn Starch Sodium Stearoyl-Lactylate, Ammonium Sulfate, Niacin, Calcium Peroxide, Iron, (Ferrous Sulfate), Potassium Bromate, Thiamine, Mononitrite, Riboflavin, Calcium Phosphate. Recall # F-1218-2011;
 
2) Waco's BESTYETT SANDWICHES Made Fresh Daily Pimento Cheese, Ingredients: Flour, Water, Corn Syrup, Nonfat Milk, Contains 2% or less of the following: Partially Hydrogenated Soybean Oil, Salt, Yeast, Mono and Diglycerides, Calcium Stearoyl-2-Lactylate, Calcium Sulfate, Malted Barley, Calcium Propionate (to retard spoilage), Corn Starch, Sodium Stearoyl-Lactylate, Ammonium Sulfate, Niacin, Calcium Peroxide, Iron, (Ferrous Sulfate), Potassium Biomate, Thiamine Mononitrate, Riboflavin, Calcium Phosphate, Pimento Cheese: Imitation Cheese (Whey, Partially Hydrogenated Soybean Oil, Sodium Caseinate, Cheese Cheddar, Swiss, and Colby (Milk, Cheese Culture, Salt, Enzymes). Water, Sodium Phosphate, Salt, Whey, Protein Concentrate, Skim Milk, Lactic Acid, Natural & Artificial Flavor, Sorbic Acid as a preservative, Milkfat, Sodium Citrate, Artificial Color). Salad Dressing, Pimentos, Red Peppers, Water, Dehydrated Cheese (Whey Cheddar Cheese (Milk, Cheese Cultures, Salt, Enzymes, Calcium Chloride], Salt, Disodium Phosphate, FD&C Yellow #5 and #6), Potassium Sorbate and Sodium Benzoate (as preservatives). Recall # F-1219-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Waco's Bestyett Sandwiches, Waco, TX, press release on April 8, 2011. FDA initiated recall is ongoing. 
REASON
The products contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
35 sandwiches
DISTRIBUTION
TX
___________________________________
PRODUCT
CILANTRO in 1/2 lb and 1 lb. bulk bags --- The product is packaged in a sealed, clear plastic bag. Recall # F-1220-2011
CODE
Lot code: 6347 (product was packaged on 04/09/11 - Julian calendar date 99); Recall expansion: Lot code: 6361(Wash Date Julian code 110 which represents 04/20/2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Satur Farms LLC, Cutchogue, NY,  by press release and letter dated April 20, 2011 and Recall expansion: by press release and letters dated April 29, 2011.
Manufacturer: Satur Farms, Belle Glade, FL. FDA initiated recall is ongoing.
REASON
Product was found to be contaminated with Salmonella based on sampling and analysis by USDA and New York State Department of Agriculture & Markets. 
VOLUME OF PRODUCT IN COMMERCE
Lot 6347 - 138 lbs; Recall Expansion: Lot 6361- 88.5 lbs.
DISTRIBUTION
NY
___________________________________
PRODUCT
Cucumbers, Plain, Raw. Raw cucumbers in white and green cardboard box with white, black and green lettering reads in part: front "***PRODUCT OF: USA***NATURE'S DELIGHT***FRUITS & VEGETABLES 1 1/9 Bu PRODUCT OF: USA. Recall # F-1221-2011
CODE
PL-RID-002990
RECALLING FIRM/MANUFACTURER
Recalling Firm: L&M Companies, Inc., Raleigh, NC, by telephone and e-mail beginning April 21, 2011.
Manufacturers: Passline Farms, Labelle, FL
L&M Companies Inc., Immokalee, FL. FDA Initiated recall is ongoing.
REASON
FDA notified the firm that a sample of cucumbers tested positive for Salmonella. The affected cucumbers are beyond their shelf life.
VOLUME OF PRODUCT IN COMMERCE
1,590 cartons
DISTRIBUTION
NY, FL, IL, IN, MS, NE, TX and WY
___________________________________
PRODUCT
1) Jonathan's Alfalfa Sprouts - 4 oz, 8 oz packaged in plastic clamshell. F-1236-2011;
 
2) Jonathan's Alfalfa with Radish Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1237-2011;
 
3) Jonathan's Gourmet Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1238-2011;
 
4) Jonathan's Alfalfa with Dill Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1239-2011;
 
5) Jonathan's 4 oz Organic Alfalfa, packaged in plastic clamshell. Recall # F-1240-2011;
 
6) Jonathan's 4 oz Organic Alfalfa with Radish Sprouts, packaged in plastic clamshell. Recall # F-1241-2011;
 
7) Jonathan's Organic Sprout Salad 4 oz packaged in plastic clamshell. Recall # F-1242-2011;
 
8) Jonathan's 4 lb Bulk Alfalfa Sprout in 2 lb bags in a 13x9x6 cardboard carton and 5lb Bulk Alfalfa in waxed 18x11 cardboard cartons. Recall # F-1243-2011;
 
9) Jonathan's 5 lb Bulk Organic Alfalfa Sprouts in waxed 18 x 11 cardboard cartons. Recall # F-1244-2011
CODE
1) - 7) Sell-by dates 4/22 through 5/7
8) and 9) Code dates prior to 412
RECALLING FIRM/MANUFACTURER
Jonathan's Sprouts Inc., Rochester, MA, by telephone, letter and press release on April 19, 2011 and April 22, 2011. Firm initiated recall is ongoing.  
REASON
Product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,340 lbs
DISTRIBUTION
CT, DE, MA, NH, VT, RI, ME, NY, MD, NJ, PA
___________________________________
PRODUCT
Twist Tie Labeling for Cilantro Bunches (Publix only): "***CILANTRO #4889***PRODUCT OF USA***0 33383 80104 9***COOSEMANS WORLDWIDE***. Publix Case Labeling: "CILANTRO PUBLIX ITEM #24341 30 BUNCHES - (01) 45035377134044***PRODUCT OF USA." Chaney Brothers Box: "***FRESH HERBS***GARDEN FRESH HERBS***1 LB***CILANTRO***. C.H. Robinson Case Labeling - Tobacco Box:***PACKAGING: CS TT SLV ZIP*** Cilantro***PERISHABLE KEEP IN A COOLER***." C.H. Robinson Case Labeling - Rock Garden Box: "***rock garden***NET WT: 1 LB BAG 1 DOZEN 1 KILO BAG (35-40*F) - HERBES - (2-4*C) (50-60*F)-BASILS-(10-15*C) KEEP REFRIGERATED***" US Foodservice Case Labeling: "***rock garden***NET WT: 1 LB BAG 1 DOZEN 1 KILO BAG (35-40*F) - HERBES - (2-4*C) (50-60*F)-BASILS-(10-15*C) KEEP REFRIGERATED***" Jaycee Herb and China Cabinet - Tobacco Box: "*** From rock garden Fresh Cut Herbs***PACKAGING: CS TT SLV ZIP*** Cilantro***PERISHABLE KEEP IN A COOLER***." Recall # F-1245-2011
CODE
Lot # 58992
RECALLING FIRM/MANUFACTURER
Herbs Unlimited Inc., Miami, FL, by telephone and letter beginning on April 28, 2011. FDA initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
433 pieces
DISTRIBUTION
FL, Canada
___________________________________
PRODUCT
1) Glenview Farms Mild Cheddar Feather Shred cheese: in cases of 4/5 lbs bags. Mild Cheddar feather shred (no label/Brand), 4 / 5 lb bags. Glenview Farms - Item number 99400, Manufacturing plant number 06-114; No label- item number  98615. Recall # F-1256-2011;
 
2) Cubed 1/2" mild cheddar in cases of 4/5 lbs bags, no label Item number 03001, Manufacturing plant number 06-114. Recall # F-1257-2011;
 
3) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Swiss/processed jack w/jalapeno pepper, 3/5 lb bags. Item number 98939, Manufacturing plant number 06-114. Recall # F-1258-2011;
 
4) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Swiss/Monterey jack w/jalapeno pepper, 3/5 lb bags. Item number 98940, lot code: 11035H, Manufacturing plant number 06-114. Recall # F-1259-2011;
 
5) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Colby Jack/Monterey jack w/jalapeno pepper, 3/5 lb bags. Item number 98941, Manufacturing plant number 06-114. Recall # F-1260-2011;  
 
6) California Select Farms, mild cheddar cheese cubes, 2 / 5 lb bags. Item number 02294, Manufacturing plant number 06-114. Recall # F-1261-2011;  
 
7) Cheswick brand Medium cheddar feather shred, 4/5 lb bags. Item number 02954, Manufacturing plant number 06-114. Recall # F-1262-2011;
 
8) James Farm Jack/cheddar feather shred, 4/5 lb bags. Item number 96990, Manufacturing plant number 06-114. Recall # F-1263-2011;
 
9) Parmesan, shaved, 2/5 lb bags Brand names of Arrezzi and Bellafo. Item number 02858, 2863S1, Manufacturing plant number 06-114. Recall # F-1264-2011
CODE
1) - 9) Lot code: 11035H
RECALLING FIRM/MANUFACTURER
Pacific Cheese Co., Hayward, CA, by letter on February 18, 2011. Firm initiated recall is ongoing.
REASON
Firm found that through finished product testing that cheese contained L monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
3,700 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Label on buckets: CKN Vanilla Whey, packaged in 7.5-lb. plastic buckets. Label in customer binders: CKN Nutrition Whey Advanced Vanilla, net wt. 7.5. lbs., containing whey concentrate, whey isolate, calcium caseinate, and egg white. Recall # F-1265-2011;
 
2) Label on buckets: CKN Chocolate Whey, packaged in 7.5-lb. plastic buckets. Label in customer binders: CKN Nutrition Whey Advanced Chocolate, net wt. 7.5. lbs., containing whey concentrate, whey isolate, calcium caseinate, and egg white. Recall # F-1266-2011
CODE
1) and 2) Lot # N2011027
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Shake Guy, LLC, Springfield, MO, by e-mails on February 14, 2011 and May 5, 2011.  
Manufacturers: The Shake Guy, LLC, Springfield, MO; Nellson Nutraceutical Inc., Irwindale, CA. Firm initiated recall is complete
REASON
The whey used in the manufacture of the finished products was potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12/7.5-lb. buckets chocolate and 5/7.5-lb. buckets vanilla
DISTRIBUTION
KS, LA
___________________________________
PRODUCT
The affected product is individually packaged in burgundy colored paperboard trays covered with clear plastic shrink wrap. The principal display panel on the side of the loaf reads in part: "Wolferman's***Cranberry Nut Natural and Artificial Flavor Tea Bread Net wt 11 oz. (311 g)". The product subject to recall are loaves that contain an incorrect ingredient statement that is intended for a different flavored tea bread. The ingredient label is on the bottom of the loaves. The CORRECT label reads in part: "***CRANBERRY NUT TEA BREAD***INGREDIENTS: Sugar, ***Walnut Pieces***CONTAINS WALNUTS, WHEAT, EGGS, MILK, SOY. ***Made for Wolferman's, A DBA of Harry and David, Medford, OR***". The INCORRECT label that was applied to some of the Cranberry Nut loaves reads in part: "CHERRY ALMOND TEA BREAD***INGREDIENTS: SUGAR, ***SLICED ALMONDS***CONTAINS WHEAT, EGGS, SOY, ALMONDS, MILK. Recall # F-1293-2011
CODE
Each loaf is labeled with a lot code of: "0321". 0 = the year of production (i.e. 2010) 321 = the julian date of production The ingredient panel of correctly labeled Cranberry Nut tea breads contains a bar code of "07147201760". The ingredient panel of Cherry Almond does NOT have a bar code. The products do not have an expiration or best-by date.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wolferman's / Qvc, Medford, OR, by telephone and letters beginning May 6, 2011.
Manufacturer: Bernice's Foods Inc., Kansas City, KS. Firm initiated recall is ongoing.
REASON
Undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
Approximately 729 loaves
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cross Valley Farms Grape tomatoes in 10 lb boxes. Recall # F-1299-2011
CODE
Lot: 0511521C
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Foodservice - Sierra Div., Reno, NV, by telephone on May 9, 2011.
Manufacturer: Six L's Packing Company, Inc., Immokalee, FL. Firm initiated recall is ongoing.
REASON
Grape tomatoes distributed under the Cross Valley Farms brand name were provided by Six L and are under recall for salmonella.
VOLUME OF PRODUCT IN COMMERCE
14 x 10 lb boxes
DISTRIBUTION
CA, NV
___________________________________
PRODUCT
1) Safeway's Eating Right Veggie Party Platter (Universal Product Code 79893-10708, weight 3 pounds, 6 ounces). Recall # F-1300-2011;
 
2) Mann's Veggies On the Go (Universal Product Code 16519 01411-6, weight 1 pound, 2 ounces). Recall # F-1301-2011;
 
3) Mann's Snacks on the Go with Celery, Carrots, Tomatoes (universal product code16519 01501-4, weight 8.75 ounces). Recall # F-1302-2011;
 
4) 1) Mann's Vegetable Platter Large (Universal Product Code 16519 01407-9, 2 pounds, 8 ounces); 2) Mann's Vegetable Platter Large (Universal Product Code 16519 01405-5, 3.5 pounds). Recall # F-1303-2011
CODE
1) Best if used by dates ranging from 05-09 to 05-16 2011;
2) Best if used by dates ranging from 05-09 to 05-16 2011;
3) Best if used by dates ranging from 05-09 to 05-16 2011;
4) 1) Best if used by dates ranging from 05-09 to 05-16 2011; 2) Best if used by dates ranging from 05-09 to 05-16 2011
RECALLING FIRM/MANUFACTURER
Mann Packing Co Inc., Salinas, CA, by press release and letters on May 7, 2011. Firm initiated recall is ongoing. 
REASON
The grape tomatoes have the potential to be contaminated with salmonella. The firm received the product from a vendor who was supplied by Six L's Packing Company, Inc. of Immokalee, Florida.
VOLUME OF PRODUCT IN COMMERCE
1100 - 10 lb cases (11000 lbs)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Good Eats Chef Salad 8 ounce, Item# 60826766800034.Recall # F-1304-2011;
 
2) Good Eats Fresh Veggies and Ranch Snack Cup, 4.25 ounce, Item# 40826766801129. Recall # F-1305-2011;
 
3) Good Eats Side Garden Salad, 5 ounce, Item# 60826766800010. Recall # F-1306-2011;
 
4) Good Eats Mediterranean Mixed Greens, 7.5 ounce, Item# 60826766800058. Recall # F-1307-2011;
 
5) Good Eats Ovenable Southwest Medley, 5 ounce, Item# 20826766801552. Recall # F-1308-2011;
 
6) Walgreens Vegetable Garden Salad, 10.5 ounce, Item# 40049022542424. Recall # F-1309-2011;
 
7) Walgreens Greek Salad, 10.5 ounce; Item# 40049022542294. Recall # F-1310-2011;
 
8) Walgreens Mozzarella and Tomato Salad, 9 ounce, Item# 40049022556414. Recall # F-1311-2011;
 
9) Walgreens Veggie Tray with Ranch Dip, 5.25 ounce, Item# 40049022558678. Recall # F-1312-2011
CODE
1) Code date 5/7/11;
2) Code Date 5/7/11;
3) Code Date 5/7/11, Expire 5/6/11;
4) Code Date 5/7/11;
5) Code Date 5/7/11;
6) Code Date 5/7/11;
7) Code Date 5/7/11;
8) Code Date 5/7/11;
9) Expire 5/9/11
RECALLING FIRM/MANUFACTURER
GH FOODS CA LLC, Sacramento, CA, by visit on May 2, 2011. Firm initiated recall is ongoing.
REASON
The grape tomatoes have the potential to be contaminated with salmonella. The firm received the product from a vendor who was supplied by Six L's Packing Company, Inc. of Immokalee, FL.
VOLUME OF PRODUCT IN COMMERCE
170 individual units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Elsie Grace's Zippy Bacon Dip, packaged in .12-oz. plastic bags. Recall # F-1324-2011;
2) Elsie Grace's It's Smokin', packaged in .08-oz. plastic bags. Recall # F-1325-2011;
3) Elsie Grace's Cheesy Onion Dip, packaged in .08-oz. plastic bags. Recall # F-1326-2011;
4) Elsie Grace's Hearty Potato Soup Mix, packaged in 10.6-oz. paper bags. Recall # F-1327-2011;
5) Elsie Grace's Spuds & Cheese Soup, packaged in 10.6-oz. paper bags. Recall # F-1328-2011;
6) Elsie Grace's Broccoli Cheese Soup, packaged in paper bags (no net weight). Recall # F-1329-2011;
7) Elsie Grace's White Chili Soup Mix, packaged in 9.9-oz. paper bags. Recall # F-1330-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Elsie Grace's Gift Shoppe, Frankfort, KS, by press release on April 26, 2011 and by letters on April 29, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared allergen (soy, milk, and wheat).
VOLUME OF PRODUCT IN COMMERCE
2,236 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oberweis Dairy Super Premium Brownie Fudge Twirl Ice Cream (artificial flavor added); packed in One Quart (946 mL) round cardboard cartons; UPC 6 16029 06455 0. UPC 6 16029 06455 0. Recall # F-1331-2011
CODE
All dates
RECALLING FIRM/MANUFACTURER
Oberweis Dairy, Inc., North Aurora, IL, by press release on May 10, 2011. Firm initiated recall is ongoing.
REASON
The brownie inclusion in the ice cream contains eggs which are not declared in the ingredients statement on the label.
VOLUME OF PRODUCT IN COMMERCE
3,989 quarts
DISTRIBUTION
IL, MO, IN, WI, MI, VA
___________________________________
PRODUCT
Product is a chili powder blend packaged in sealable plastic bags in weights of 8oz, 1 lb, 5 lbs, 6 lbs, 8 lbs, and 10 lbs. Product labeled in part: "EPICUREAN ORGANICS CHILI POWDER***A blend of organic Red Pepper, organic Cumin seed, Sea Salt, organic Garlic, organic Oregano and Silicon Dioxide***Certified Organic***Lot#7215 Packaged and distributed by mountain rose herbs Eugene, OR 97405***Net Wt: 8 oz (227 gm) ***". The labels are the same for each size product except for the stated net weight (8 oz, 1 lb, etc.). Recall # F-1333-2011
CODE
Lot #7215
RECALLING FIRM/MANUFACTURER
Mountain Rose Herbs, Eugene, OR, by telephone, e-mail, and letter beginning April 7, 2011. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Total of 229 pounds. (Number of bags by size: 8oz=38; 1lb=141; 5lb=7; 6lb=1; 8=1; 10lb=2)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Seasoned Cuttlefish: Net Wt. 15 lbs. Ingredients: Cuttlefish, vegetable oil, chili paste, sugar, malt syrup, sesame seeds, garlic, hon-dashi (salt, monosodium glutamate, lactose, sugar, dried bonito powder, yeast extract, disodum succinate). Recall #F-1334-2011
CODE
3/22/11 hand written on carton
RECALLING FIRM/MANUFACTURER
Hnk Inc., Honolulu, HI, by telephone on March 28, 2011. Firm initiated recall is ongoing.
REASON
As part of HACCP plan firm conducted quarterly testing and found Listeria in their finished product.
VOLUME OF PRODUCT IN COMMERCE
11 cases, 5 cases of dried seasoned squid
DISTRIBUTION
HI
___________________________________
PRODUCT
Vietnamese Cashew Nut Kernels Crop 2010, Product of Vietnam, Cashew LP, packaged in flex pack inside cardboard carton, 50 lbs. Raw. Recall #F-1335-2011
CODE
Units: USG70115, 34766
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by telephone and email on November 19, 2010 and by letter dated November 22, 2010.  
Manufacturer: Dakao Agricultural Produce Export And Production Co., Ltd, Ho Chi Minh City, Vietnam. Firm initiated recall is ongoing.
REASON
Cashew pieces have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
28,050 lbs
DISTRIBUTION
CA, OR, TX
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Mama Rose's Cilantro Con Queso, UPC Code: 7 90648 09020 3, 12 fl oz (340ml) jars. Recall # F-1228-2011;
 
2) Mama Rose's Hopi Corn Salsa sold as: Mama Rose's Hopi Corn Salsa, UPC Code: 7 906480 1070 6, 12oz jars; Fred Harvey Hopi Corn Salsa, UPC Code: 4 52030 16600 4, 12oz jars. Recall # F-1229-2011; 
 
3) Mama Rose's Garlic Con Queso, UPC Code: 7 906480 9010 4, 12 fl oz (340ml) jars. Recall # F-1230-2011;
 
4) Mama Rose's Viper Venom Con Queso, UPC Code: 7 90648 09000 5, 12 fl oz (340ml) jars. F-1231-2011
CODE
1), 3), and 4) All 6 digit Lots beginning with 260& & 270& Note: All Salsa with an expiration dates of 01/10/12 and earlier;
2) All 6 digit Lots beginning with 260& & 270& Note: All Salsa with an expiration dates of 01/06/13 and earlier;
RECALLING FIRM/MANUFACTURER
Mama Rose's Gourmet Foods, Phoenix, AZ, by press release on January 20, 2011 and by letters on January 24, 2011. FDA initiated recall is ongoing.
REASON
The recall was initiated because the listed products have the potential to be contaminated with Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
150 cases
DISTRIBUTION
AZ, CO, WA
___________________________________
PRODUCT
IQF vacuum packed 6 oz Ahi tuna steaks packed in a 10 lb master case. Producers-FDA Registration Number 19050729230 Product of Thailand no.1170 Wild Caught***PD.072310 YELLOWFIN TUNA STEAK 6 oz Net wt 10 lbs, Ingredients: Tuna***U.S. Patent No 5972401. Recall # F-1332-2011
CODE
Lot number: 269, Expiration date on cartons is: "EXP.072212"
RECALLING FIRM/MANUFACTURER
Pacific Seafood Co., Inc., Clackamas, OR, by telephone on March 30, 2011. Firm initiated recall is complete.
REASON
Product may have elevated histamine levels.
VOLUME OF PRODUCT IN COMMERCE
710 lbs
DISTRIBUTION
AZ, CA, ID, OR, and WA. (primarily OR)
___________________________________
PRODUCT
1) Garlic Paste, Ravi, Net Wt 32 oz. Recall # F-1233-2011;
2) Ginger Paste, Ravi, Net Wt 32 oz. Recall # F-1234-2011;
3) Garlic & Ginger Paste, Ravi, Net Wt 32 oz. Recall # F-1235-2011
CODE
1) Lot1020311;
2) Product shipped on 2/21/2011;
3) Lot #1010
RECALLING FIRM/MANUFACTURER
Exotic Foodline LLC, Richardson, TX, by letter on March 15, 2011. FA initiated recall is ongoing.
REASON
Products may contain elevated PH ratios.
VOLUME OF PRODUCT IN COMMERCE
2,400 jars
DISTRIBUTION
TX
___________________________________
PRODUCT
1) “Recaito Criollo Bohio” 6 oz, 12 oz and 32 oz - Cilantro-based seasoning. Recall # F-1249-2011;
2) "Sofrito Criollo Bohio" 6 oz, 12 oz and 32 oz Combination of aromatic herbal ingredients. Recall # F-1250-2011;
3) "Mr Special Sofrito" 12 oz Combination of aromatic herbal ingredients. Recall # F-1251-2011;
4) "Mr Special Recaito" 12 oz Cilantro-based seasoning. Recall # F-1252-2011
CODE
1) B26710, B26610, B27710, B27410, B28410, B29310, B29410, B30010, B30110, B30710, B32810, B34310, B34910, B34710, B36410, B02711, 03211, B03911, B06311, B07311, B08411, B32210, B35410, B04711, B26710, B21710, B28510, B28610, B30210, B32310, B34410, B02611, B03411, B27010, B27110, B27910, B31310, B33610, B35510, B04011, B06311, B32110, B35410, and B04711;
 
2) B24310, B27110, B27310, B28110, B31210, B33610, B35510, B03911, B04011, B06311, B26710, B26610, B27710, B27410, B28410, B29310, B29410, B30010, B30110, B30710, B32810, B34310, B34910, B34710, B36410, B02711, B03211, B03911, B06311, B07311, B08411, B32210 B35410 B04711;
 
3) B27210, B30810, and B31410;
 
4) B27210, B30910, and B31510
RECALLING FIRM/MANUFACTURER
Bohio International Corp., Bayamon, PR, by letters on April 27, 2011. FDA initiated recall is ongoing.
REASON
Bohio International moved its operation to new facilities and did not register with FDA the location of the processing establishment nor the scheduled process for acidified foods. Hence, this results in the potential for bacterial growth, especially Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
175,270 units
DISTRIBUTION
PR and US Virgin Islands
___________________________________
PRODUCT
1) Cobblestone Mill(R) 100% Whole Wheat Bread, 16 oz, UPC 0 72250 04171 3. Recall # F-1294-2011;
 
2) 100% Whole Wheat English Muffins sold under the following names: (1) Nature's Own(R) 100% Whole Wheat English Muffins, net wt. 12 oz (340g), UPC 0 72250 00376 3 (2) Sweetbay (TM) SUPERMARKET 100% Whole Wheat English Muffins, net wt. 12 oz (340g), UPC 0 99614 64218 8. Recall # F-1295-2011;
 
3) Honey Wheat English Muffins sold under the following brands: (1) Natural Grains(R) Honey Wheat English Muffins, net wt. 12 oz (340g), UPC 0 73105 92029 0 (2) Nature's Own(R) Honey Wheat English Muffins, net wt. 12 oz (340g), UPC 0 72250 00876 1. Recall # F-1296-2011;
 
4) Nature's Own(R) 100 Calorie Multi Grain English Muffins, net wt. 12 oz (340g), UPC 0 72250 00377 3. Recall # F-1297-2011
CODE
Best by dates: May 11 0355 119 and May 12 0355 120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flowers Foods, Thomasville, GA, by visits, telephone, e-mail and press release on May 3, 2011.
Manufacturer: Flowers Bakery Of Montgomery LLC, Montgomery, AL. Firm initiated recall is ongoing.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
60,180 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Vegetarian Sausage, Breakfast Style, 16 oz. packages, UPC 054917981006. Recall # F-1313-2011;
 
2) Vegetarian Sausage, Chorizo, 16 oz. packages, UPC 054917988418. Recall # F-1314-2011;
 
3) Vegetarian Pat�, Wild Mushroom, 16 oz. packages, UPC 054917981051. Recall # F-1315-2011;
 
4) Tofu, Fine Herb, Organic, 16 oz. packages, UPC 754917901164. Recall # F-1316-2011;
 
5) Tofu, Italian Herb, Organic, 16 oz. packages, UPC 754917902161. Recall # F-1317-2011
 
6) Tofu, Spinach Jalapeno, Organic, Seasoned, 8 oz. packages, UPC 667262808081. Recall # F-1318-2011;
 
7) Tofu, Peanut & Ginger, Organic, Seasoned, 8 oz. packages, UPC 667262806087. Recall # F-1319-2011;
 
8) Tofu, Pesto, Organic, Seasoned, 8 oz. packages, UPC 667262801051. Recall # F-1320-2011;
 
9) Tofu, Spicy Thai, Organic, Seasoned, 8 oz. packages, UPC 667262871054. Recall # F-1321-2011;
 
10) Tofu, Indian Masala, Organic, Seasoned, 12 oz. packages, UPC 667262805080. Recall # F-1322-2011;
 
11) Tofu, Garlic Shiitake, Organic, Mushroom Seasoned, 12 oz. packages, UPC 667262800085. Recall # F-1323-2011
CODE
1) Use by date: 5/16/11;
2) Use by date: 5/16/11;
3) Use by date: 5/2/11;
4) Use by dates: 4/25/11, 5/16/11;
5) Use by date: 4/25/11;
6) Use by date: 6/16/11;
7) Use by date: 6/23/11;
8) Use by date: 6/23/11
9) Use by date: 6/2/11;
10) Use by date: 6/6/11;
11) Use by date: 5/9/11
RECALLING FIRM/MANUFACTURER
Twin Oaks Community Foods, Inc., Louisa, VA, by e-mail and letter on March 24, 2011 and March 25, 2011. Firm initiated recall is ongoing.
REASON
Labels on the food do not specify the current name and place of business of the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
372 units
DISTRIBUTION
VA, NC, GA, and FL
___________________________________
PRODUCT
1) Amoxilina Capsules, 500mg, Dietary Supplement, UPC 619114010081. Recall # F-1336-2011;
 
2) Amoxilina Syrup, fl. oz., Dietary Supplement, Activates the immune system, UPC 619114010074. Recall # F-1337-2011;
 
3) Bisolbom, Broncheal Support Syrup, Adult, 4.06 fl. oz, Dietary Supplement, UPC: 619114010104. Recall # F-1338-2011;
 
4) Bisolbom, Broncheal Support Syrup, Child, 4.06 fl. oz, Dietary Supplement, UPC: 619114010198. Recall # F-1339-2011;
 
5) Neolubrina Fuerte, Syrup, Child, 3.38 fl. oz., Dietary Supplement, Effective against Fever and Pain, NDC 619114010234. Recall # F-1340-2011;
 
6) Neolubrina Fuerte, Tablets, 500 mg, Dietary Supplement, Effective against Fever and Pain, UPC: 619114010241. Recall # F-1341-2011;
 
7) Pentreximil Plus, Adult, 500 mg, 30 capsules, Activates the Immune System, UPC: 619114010012. Recall # F-1342-2011;
 
8) Pentreximil Plus, Adult, 3.4 fl. zo. (100 mL), Natural Antibiotic Qualities, UPC: 619114010050, Dietary Supplement. Recall # F-1343-2011;
 
9) Terramocina Capsules, 500 mg, Natural Qualities help with pain and stomach infection, Dietary Supplement, UPC: 619114010296. Recall # F-1344-2011;
 
10) Maxi-Vermex Tablets, 6 tablets, Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010302. Recall # F-1345-2011;
 
11) Maxi-Vermex Tablets, 1 way, 1 tablet, Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010326. Recall # F-1346-2011;
 
12) Maxi-Vermex, Syrup Bottle with 1 oz., Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010319. Recall # F-1347-2011;
 
13) VitaA Derogil, Socucion Infantil (Child) en Gotas Auxiliar en la pervencion y tratamiento del la GRIPE (Helps in the prevention and treatment of COLDS), .50 oz (15ml), UPC #619114010142). Recall # F-1348-2011;
 
14) VitaA Derogil, Socucion Adulto (Adult), Auxiliar en la pervencion y tratamiento del la GRIPE (Helps in the prevention and treatment of COLDS), .50 oz (15ml), UPC #619114010159. Recall # F-1349-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Multimex, Tucker, GA, by press release on May 9, 2011 and by letter on May 11, 2011. FDA initiated recall is ongoing.
REASON
Label is false and misleading; Products are being promoted as antibiotics and make other medical claims.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA, CO, DE, GA, IN, IL, NC, TN and TX
 
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Cool River sin azucar Bebida de Acerola 8 oz (Cool River without sugar Acerola Beverage 6% Juices). Recall # F-1222-2011
CODE
Lot 196 (Expires: 07/31/2011) & Lot 201 (Expires: 08/20/11)
RECALLING FIRM/MANUFACTURER
San Mar Manufacturing Corp., Catano, PR, by letter on April 27, 2011. FDA initiated recall is ongoing
REASON
Lack of phenylketonurics warning statement (product contains aspartame) in product label.
VOLUME OF PRODUCT IN COMMERCE
1,062 units
DISTRIBUTION
PR
___________________________________
PRODUCT
NutraSweet, Zero Calorie Sucralose Sweetener, Net Wt 0.035 oz. (1g). Recall # F-1298-2011
CODE
Lot numbers: Z0502C53, Z0513B53, Z0513C53, Z1041B53, and Z1041B63
RECALLING FIRM/MANUFACTURER
American Sugar Refining, Dallas, TX, by letter on May, 10, 2011. Firm initiated recall is ongoing.
REASON
Incorrect product labeling declared Calcium Saccharin and Calcium Silicate, which are not ingredients in this product.
VOLUME OF PRODUCT IN COMMERCE
396 cases (2000 packets per case)
DISTRIBUTION
LA, CA, KS, and WI
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Urinary Catheterization System, Rx only, Catalog Number: B6FB, B8FB, B10FB, B12FB, B14FB, B16FB, B18FB, B12CB, B14CB, B16CB, B12SB, B14SB, B12RB, B14RB, B16RB, B14FBK and B14FB-Female. Recall # D-531-2011
CODE
Lot numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187, 0189, 0190, 0191, 0193, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1111, 1112, 1114, 1115, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 8127, 8128, 8129, 8130, 8131, 8132, 8133, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8141, 8142, 8143, 8144, 8145, 8146, 8147, 8148, 8149, 8150, 8151, 8152, 8153, 8154, 8155, 8156, 8157, 8158, 8160, 8161, 8162, 8163, 8164, 8165, 8166, 8167, 8168, 8169, 8170, 8171, 8172, 8173, 8174, 8175, 8176, 8177, 8178, 8179, 8180, 8181, 8182, 8183, 8184, 8185, 8186, 8187, 8188, 8189, 8190, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9119, 9120, 9121, 9122, 9123, 9124, 9125, 9126, 9127, 9128, 9129, 9130, 9131, 9132, 9133, 9134, 9135, 9136, 9137, 9138, 9139, 9141, 9142, 9143, 9144, 9145, 9146, 9147, 9148, 9149, 9150, 9151, 9152, 9153, 9154, 9155, 9156, 9157, 9158, 9159, 9160, 9161, 9162, 9163, 9164, 9165, 9166, 9167, 9168, 9170, 9171, 9172, 9173, 9174, 9175, 9176, 9177, 9178 and 9179
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apogee Medical, Inc., Youngsville, NC, by letter on April 13, 2011.  
Manufacturers: Apogee Medical, Inc., Youngsville, NC;  
H & P Industries, Inc., Hartland, WI. FDA initiated recall is ongoing.
REASON
CGMP Deviations: The Kits contain Povidone Iodine (PVP) Swabstick which are being recalled by H&R Industries due to failure to comply with FDA current cGMP regulations.
VOLUME OF PRODUCT IN COMMERCE
8.8 million kits
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Perindopril Erbumine Tablets, 2 mg, 100-count tablets per bottle, Rx only; NDC 68180-235-01, UPC 3 68180 23501 9. Recall # D-529-2011
CODE
Lot #: 3100748, 3100747, 3100646, Exp 01/12; 3105582, Exp 11/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letter dated April 7, 2011. 
Manufacturer:Lupin Limited, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.
REASON
 Subpotent (Single Ingredient) Drug: Product failed to meet assay results at the 12 month long term stability test point.
VOLUME OF PRODUCT IN COMMERCE
4,962 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Sudafed 24 Hour (Pseudoephedrine HCl) 240 mg, Extended Release Tablets, Long-Acting Nasal Decongestant, 10 count blister, OTC; NDC: 50580-669-10. Recall #D-530-2011
CODE
Lot number: 1004651, Exp date: 2/14; Lot number: 1004652, Exp. date: 2/14; Lot number: 1005870, Exp. date: 3/14; Lot number: 1005874, Exp. date: 3/14; Lot number: 1008467, Exp. date: 6/14; Lot number: 1008468, Exp. date: 6/14; Lot number: 1009532, Exp. date: 6/14; Lot number: 1010850, Exp. date: 7/14; Lot number: 1013065, Exp. date: 7/14.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letter on February 25, 2011.  
Manufacturer: Alza Corp., Vacaville, CA. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Miscart/Mispack: Typographical error on the carton display panel drug facts directions - the word "not" in the third line is repeated.
VOLUME OF PRODUCT IN COMMERCE
667,632 (10 tablets/carton)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1304-11;
2) Cryoprecipitated AHF. Recall # B-1305-11
CODE
1) and 2) Units: W149508300555; W149510208917
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by email and facsimile on February 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1379-11;
2) Red Blood Cells. Recall # B-1380-11
CODE
1) Unit: T32817;
2) Units: T32027, T30812
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by electronic mail on April 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1383-11
CODE
Units: FM52418 (part 1), FM52418 (part 2)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on April 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet leukoreduction requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1384-11
CODE
Unit: V75193
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by electronic mail on March May 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1386-11
CODE
Unit: 1152034
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by facsimile on August 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, HI
___________________________________
PRODUCT
1) Recovered Plasma. Recall #B-1402-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1403-11;
3) Fresh Frozen Plasma. Recall # B-1404-11
CODE
1) Unit: 6472310;
2) Units: 6472310; 6421722;
3) Unit: 6421772
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on December 29, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1406-11
CODE
Unit: W036511002726
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by facsimile on March 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1407-11;
2) Recovered Plasma. Recall # B-1408-11;
3) Platelets Pooled. B-1409-11
CODE
1) and 2) Unit: 22GJ31188;
3) Unit: 22LF22953
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on February 24, 2011 and letter dated March 2, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA, NJ, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1410-11
CODE
Unit: W280311900156
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone on March 8, 2011 and facsimile dated April 14, 2011. Firm initiated recall is complete.
REASON
 Blood product, labeled as leukoreduced, but which did not meet the requirements for leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1427-11;
2) Cryoprecipitated AHF. Recall # B-1429-11
CODE
1) Units: W036810166779; W036810202443;
2) Unit: W036810166779
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter on April 4, 2011 and April 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1438-11;
2) Fresh Frozen Plasma. Recall # B-1439-11;
3) Recovered Plasma. Recall # B-1440-11
CODE
1) and 2) Unit: W227710360214;
3) Unit: W227710392220
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on April 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for receiving a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, TN
___________________________________
PRODUCT
Red Blood Cells Apheresis. Recall # B-1441-11 
CODE
Unit: W050911001629
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by telephone on April 13, 2011 and by letter dated April 16, 2011. Firm initiated recall is complete.
REASON
Blood product, which failed quality control testing for red cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1442-11;
2) Fresh Frozen Plasma. Recall # B-1443-11;
3) Platelets. Recall # B-1444-11
CODE
1), 2), and 3) Unit: W035211020862D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 25, 2011 and May 3, 2011, by e-mail on April 18, 2011, and by letter dated April 18, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, TX
___________________________________
PRODUCT
Source Plasma. Recall # B-1447-11
CODE
Unit: 0600118174
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Odessa, TX, by letter dated March 14, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Spain
___________________________________
PRODUCT
1) Recovered Plasma Recall # B-1448-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1449-11
CODE
1) and 2) Unit: 12GN37250
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter on February 18, 2011. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of post donation information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA, CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1306-11
CODE
Units: W149508300555; W149510208917
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by email and facsimile on February 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1382-11
CODE
Unit: 3699443
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by telephone and facsimile on September 26, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received an incomplete health history screening, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1387-11
CODE
Unit: 1152034
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by facsimile on August 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, HI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1405-11
CODE
Unit: 12LP39077
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by the LOGIC system on February 25, 2011 and March 25, 2007.
Manufacturer: American Red Cross Blood Services Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. B-1428-11
CODE
Units: W036810166779; W03681020443
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter on April 4, 2011 and April 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1450-11
CODE
Unit: 10FWIC4814
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fond Du Lac, WI, by electronically on April 7, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Leukocytes. Recall # B-1445-11
CODE
Unit: W035211020862D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 25, 2011 and May 3, 2011, by e-mail on April 18, 2011, and by letter dated April 18, 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
NJ, TX
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier. The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED. Recall # Z-2064-2011
CODE
S/No’s To obtain a complete list , refer to firm's website: Defibtech.com 101000001 101001000 101001001 101001002 101001003 101001004 101001005 101001006 101001007 101001008 101001009 101001010 101001011 101001012 101001013 101001014 101001015 101001016 101001017 101001018 101001019 101001020 101001021 101001022 101001023 101001024 101001025 101001026 101001028 101001029 101001030 101001031 101001032 101001033 101001034 101001035 101001036 101001037 101001038 101001039 101001040 101001041 101001042 101001043 101001044 101001045 101001046 101001047 101001048 101001049 101001052 101001053 101001055 101001056 101001058 101001059 101001060 101001061 101001062 101001063 101001064 101001065 101001066 101001067 101001068 101001069 101001070 101001071 101001072 101001073 101001074 101001075 101001076 101001077 101001078 101001079 101001080 101001081 101001082 101001083 101001084 101001085 101001086 101001087 101001088 101001089 101001090 101001091 101001092 101001095 101001096 101001097 101001098 101001099 101001100 101001101 101001102 101001104 101001105 101001106 101001107 101001108 101001109 101001110 101001111 101001112 101001113 101001114 101001115 101001116 101001117 101001118 101001119 101001120 101001121 101001122 101001123 101001124 101001125 101001126 101001127 101001128 101001129 101001130 101001131 101001132 101001133 101001134 101001135 101001136 101001138 101001139 101001140 101001141 101001142 101001143 101001144 101001145 101001146 101001147 101001148 101001149 101001150 101001151 101001152 101001153 101001154 101001155 101001156 101001157 101001158 101001161 101001162 101001163 101001164 101001165 101001166 101001167 101001168 101001169 101001170 101001171 101001172 101001173 101001174 101001175 101001176 101001177 101001178 101001179 101001181 101001182 101001183 101001184 101001185 101001186 101001187 101001188 101001189 101001190 101001191 101001192 101001194 101001195 101001196 101001197 101001198 101001199 101001200 101001201 101001203 101001204 101001205 101001206 101001207 101001208 101001210 101001211 101001212 101001213 101001214 101001215 101001216 101001217 101001218 101001219 101001220 101001221 101001222 101001223 101001224 101001225 101001226 101001227 101001228 101001229 101001230 101001231 101001232 101001233 101001234 101001235 101001236 101001237 101001238 101001239 101001240 101001241 101001242 101001243 101001244 101001245 101001246 101001247 101001248 101001249 101001250 101001251 101001252 101001253 101001254 101001255 101001256 101001257 101001258 101001259 101001260 101001262 101001264 101001265 101001282 101001283 101001284 101001285 101001286 101001287 101001288 101001289 101001290 101001291 101001295 101001309 101001311 101001312 101001328 101001344 101001345 101001346 101001347 101001348 101001349 101001350 101001351 101001352 101001354 101001355 101001356 101001357 101001358 101001359 101001360 101001374 101001379 101001380 101001381 101001382 101001383 101001385 101001386 101001387 101001388 101001390 101001391 101001392 101001393 101001394 101001395 101001396 101001397 101001398 101001401 101001403 101001405 101001407 101001408 101001409 101001411 101001412 101001414 101001415 101001417 101001420 101001421 101001423 101001424 101001425 101001426 101001427 101001428 101001430 101001431 101001432 101001433 101001434 101001435 101001436 101001437 101001438 101001439 101001440 101001441 101001443 101001444 101001445 101001447 101001448 101001449 101001450 101001451 101001452 101001453 101001454 101001455 101001457 101001458 101001459 101001460 101001461 101001463 101001464 101001466 101001467 101001468 10100
RECALLING FIRM/MANUFACTURER
Defibtech, LLC, Guilford, CT, by letter dated March 11, 2011. Firm initiated recall is ongoing.
REASON
Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process.
VOLUME OF PRODUCT IN COMMERCE
91, 472 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Luxtec� MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. Recall # Z-2060-2011
CODE
Serial numbers: 031009 0416410 035709 023210 102109 053510 126709 039810 0310710 0411210 057910 034910 065010 044110 064310 117209 602319 062010 022010 113009 090408 043510 117409 093108 051709 086908 118509 032510 057810 083109 043810 082708 030910 061408 054710 061310 084009 106509 053009 060110 412110 021709 033409 051109 072309 073708 080808 083408 084208 084808 092808 100808 104008 021809 071908 022609 070208 093208 103609 105609 105809 110309 110609 110709 110809 110909 111009 111109 111309 083208 090808 120308 010909 022709 075108 101209 104509 105109 106409 107809 108009 036509 122008 075208 010509 036009 061909 085209 073308 040309 031209 102309 062409 036709 122808 040709 121908 093608 101108 123308 051609 040909 010909 036209 127209 061509 106809 121808 040809 033910 036409 040209 103109 103708 121009 040909 034410 033710 122009 073809 113009 041160 076408 117409 060309 116709 075609 115009 117609 116309 074209 022309 043610 042710 032210 118709 035110 and 023410 057410 030710 116109 032310 073309 and 1110109
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated March 8, 2011 and by telephone on March 9, 2011.
Manufacturers: Integra Radionics Inc., Burlington, MS;
Integra Luxtec, Inc., West Boylston, MA. Firm initiated recall is ongoing.
REASON
Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.
VOLUME OF PRODUCT IN COMMERCE
159 units
DISTRIBUTION
Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden
___________________________________
PRODUCT
LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178. Recall # Z-2151-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 23, 2011.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.
REASON
There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.
VOLUME OF PRODUCT IN COMMERCE
47
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber. Recall #Z-2199-2011
CODE
The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Kabi, LLC, Redmond, WA, by letter dated May 6, 2011.
Manufacturer: Fresenius Hemocare Netherlands B.V, Emmer-Compascuum, Netherlands. Firm initiated recall is ongoing.
REASON
Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports. Recall # Z-2201-2011
CODE
APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories, Redmond, WA, by letter dated July 19, 2010, via FedEx.
Manufacturer: Bio Rad Laboratories, Marnes La Coquette, France. Firm initiated recall is ongoing.
REASON
The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3.2.0.19010. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2205-2011;
 
2) Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2206-2011;
 
3) Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2207-2011
CODE
1) Serial Numbers: 100103, 100019, 100023, 100170, 200047, 200013, 200005, and 1000087;
2) Serial Numbers: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010;
3) Serial Numbers: 7006, 7060, 7154, 7298, and 7349
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on March 8, 2011. Firm initiated recall is ongoing.
REASON
A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.
VOLUME OF PRODUCT IN COMMERCE
23 system units
DISTRIBUTION
DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT
___________________________________
PRODUCT
1) DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2208-2011;
 
2) DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD� Product Code: 210812 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.Recall #Z-2209-2011;
 
3) DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD� Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2210-2011;
 
4) DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2211-2011
CODE
1) Lot Numbers: 3403404 3411147 3415167 3415244 3417101 3418587;
 
2) Lot Numbers: 3409863 3415962 3416197 3416462;
 
3) Lot Numbers: 3449990 3451672 3452663 3453946 3455144 3455703 3456883 3462226 3468839 3473244 3476092 3476648 3477802 3478695 3479693 3484277 3486069 3477068 3494964 3495725;
 
4) Lot Numbers: 3450116 3452126 3452666 3453955 3455280 3455577 3456000 3456320 3457346 3459759 3462333 3463328 3463735 3464069 3473282 3474524 3476556 3478827 3478828 3478166 3496079 3495846
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated February 24, 2011.
Manufacturer: DePuy Mitek Sarl, Neuchatel, Switzerland. Firm initiated recall is ongoing.
REASON
Metal debris in the shaft component of the device.
VOLUME OF PRODUCT IN COMMERCE
10,822 units
DISTRIBUTION
Nationwide, and the countries of Australia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland
___________________________________
PRODUCT
PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest. Recall # Z-2219-2011
CODE
Serial Numbers: 03B8Y3, 20071000005, 20071000006, 20071000007, 20071000008, 20071000009, 20071000010, 20081000011, 20081000013, 20091000019, 20091000020, 20091000021, 20091000022, 20091000023, 02RCHF, 02X3NK, 034K1R, 039VDK, 039W1H, 03B4F3, 03B59R, 03B8MW, 03B8N0, 03B8QR, 03B8XX, 03B8XY, 03B8XZ, 03B8Y0, 03B8Y1, 03B8Y4, 03B8Y5, B0091T, B009BJ, B009HV, B009VJ, B00DDJ, B00DQ2, B00DQX, B00DQZ, B00DRF, B00DRP, B00DT7, B00DXM, B00DY0, B00F1Q, B00F3H, B00F3M, B00HKW, B00HKZ, B00HV4, B00HV7, B00HW3, B00HZR, B00J05, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, B00PJJ, B00PPP, B00PQ7, and P002A20090500005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 4, 2011. 
Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing
REASON
The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
VOLUME OF PRODUCT IN COMMERCE
65 units (33 units distributed to US and 32 units distributed to other countries)
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom
___________________________________
PRODUCT
Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues. Universal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900. Recall # Z-2225-2011
CODE
Serial numbers: *S-11, S-137, S-152, S-173, S-186, S-214, S-231, S-243, S-245, S-254, S36, S-233, S-234, S-235, S917P, S-237, S-238, S-239, S444, S-242, S-244, S415, S-247, S-248, S-249, S-250, S-251, S353P, S-253, S-255, S-256, S-257,S-258, S-259, S-260, S-261, S-262, S-263, S-264, S-265, S-267, S-268, S-269, S-271, S-272, S-273, S-274, S-960, S-961, S-RP-220, S-RP-140, S-RP-182, S-RP-183, S759, S767, S315P, S659, S691, S697, S703,S704, S716, S728, S739, S342P, S412, SB004, SB008, SB021, SB031, SB042, SB043, SB044, SB045, SB050, SB051, SB052, SB073, SB074, SB075, SB076, SB082, SB083, SB088, SB089, SB090, SB091, SB092, SB093, SB094, SB095, SB100, SB102, SB103, SB104, SB107, SB108, SB109, SB111, SB112, SB113, SB114, SB115, SB116, SB117, SB126,SB127, SB130, SB131, SB132, SB133, SB134, SB135, SB136, SB137, SB138, SB139, SB140, SB141, SB142,SB143, SB144, SB145, SB146, SB147, SB148, SB149, SB168, SB169, SB170, SB171, SB172, SB173, SB176,SB177, SB178, SB179, SB180, SB185, SB190, SB192, SB193, SB194, SB195, SB196, SB197, SB198, SB199, SB200, SB204, SB206, SB208, SB210, SB211, SB216, SB221, SB222, SB229, SB231, SB232, SB233, SB237, SB241, SB242, SB243, SB244, SB254, SB256, SB257, SB258, SB259, SB260, SB261, SB262, SB263, SB264, SB265, SB266, SB267, SB268, SB269, SB270, SB271, SB272, SB273, SB274, SB275, SB276, SB291, SB304P, SB327, SB337, SB44, S857, S288, S436, S3856, S3886, S626, SRP220, S714, S715P, SB153, SB154, SB155, SB156, S612, S619, S620, S625, S684, N/A, N/A, SRP223(a), S496, S497, S509, S683, N/A, N/A, S341, S595, S610, S613, S618, S635, S637, S638, S680, S862, S865, S780, S764, S770, S773, S774, S916, S511P, S707,S782, S811, S358, S359, S3866, S456, S428, S520, S430, S431, S432, S529, S455, N/A, N/A, S506, S508, S686, S849, S927, SB249, SB250, SB251, SB252, SB253, SB255, S438, S439, S440, S481, S482, S484, S485, S486, S487, S542P, S596, S694, S696, S634, S495(a), S699, S718, S744, S745, S747, S519, S-538, S818, 5871, S291,S292, SRP228, S644, S645, S650, SB175, S391, S463, S453, S310, S348, S355, S368, S369, S370, S371, S372, S373, S374, S381, S382, S383, S384, S530, S654, SB006, SB038, SB105, SB125, SB128, SB129, SB150, SB151,SB152, SB157, SB158, SB159, SB160, SB161, SB162, SB163, SB164, SB165, SB166, SB167, SB174, SB181,SB182, SB183, SB184, SB186, SB187, SB188, SB189, SB191, SB201, SB202, SB203, SB205, SB207, SB223,SB224, SB227, SB228, SB278, SB279, SB280, SB281, SB286, SB297, SB331, SB332, SB88, SB039, S469, SB005, SB010, S679, S604, S760, S776, S594, S771, S473, S772, S785, S449, S435, S551, S817, S814, S779 S710, S719, S724, S727, S419, S709, 1/1/1989, N/A, N/A, SB123, S611, 1-582, S523, S524, S526, S527, S531, S532, S533, S582, S614, S295, S296, S362, S363, S577, S677, S387, S777, S778, S3936, S416, S417, S418, S390, S521, S539, S548, S583, S655, S669, S673, S495(b), S733, S546, S477, S514, S516, S517, S333, S681, S781,S839, S706, S424, S446, S660, S726, S361, S545, S682, S700, S717, SRP185, S330, S437, N/A, N/A, N/A, N/A, S276, S277, S278, S279, S280, S281, S282, S283, S284, S286, S287, S289, S290, S297, S298, S299, S305, S307,S308, S344, S345, S346, S347, S395, S396, S397, S398, S399, S400, S401, S402, S403, S404, S405, S406, S407,S408, S409, S410, S411, S420, S421, S422, SB016, SB017, SB018, SB023, SB024, SB025, SB026, SB027, SB028, SB032, SB033, SB034, SB035, SB036, SB037, SB040, SB041, SB046, SB047, SB049, SB053, SB054, SB055,SB056, SB057, SB058, SB059, SB060, SB061, SB062, SB063, SB064, SB066, SB067, SB068, SB069, SB071,SB072, SB077, SB078, SB079, SB080, SB081, SB084, SB085, SB086, SB087, SB106LC, SB118, SB119, SB120, SB121, SB122, SRP172, SRP173, SB289, SB290, SB324, SB328, SB329, SB330, SB2PC, SB007P, S312P, S736, S749, S752, S597, S598, S599, S4206, S816, S350, S351, S356, S357, S3816, S3876, S665, S675, S851, SRP229,S551, S605, S929, S608, S609, S648, S688, N/A, N/A, N/A, N/A, N/A, N/A, S450, S758, S906, S554, S678, S559, S713, S603, N/A, N/A, N/A, N/A, S513, S788, S789, S306, S4006P, N/A, N/A, SRP211, S322, S323, S457, S458, S319P, S300, S850, S689, S560, S561, S563, S568, S570, S572, S343, S429, S580, S337, S3966, S4016, S4056P,S666PZ, SB282, SB283, SB284, SB285, SB287, SB288, S507, SB065, SB070, SB097, SB098, S366, S367, SB013,SB015, S565, SRP222, S4196, S812, 5587, 5588, 5589, S587, S589, N/A, N/A, S914, S492, S685, S493, S364,S365P, SB012, SB014, SB225, SB226, SB230, SB240, SB277, S502, N/A, N/A, S540, S541, S692, S693, S695, S555, S556, S649, S768, S783, SRP184, SRP186, S483, S720, S543, S544, S336, S360, S905, S314P, S317P,S3836, S3846P, S392, S393, S394P, S4036P, S413, S414, S479, S490, S491, S501, S510, S549, S746P, S748P,SB099, SB101, SB234P, SB235P, SB236, SB245P, SB246, SB247, SB248, SRP243, S459, S3976, S601, S602,S454, S331, SRP242, S926, S925, S633, S629, S550, S488, S489, N/A, N/A, S896, S895, S890, S302, S301, N/A, N/A, SRP231, S293, S923, S349, S750, S442, S441, SRP244, S607, S443, S586, 5586, S309, S584, S576, S471, S910, S687, S536, SRP233, SRP232, S3826, S385, S294P, S784, S753, S751, S722, S721, S711, S708, S705, S698,S579, S578, S575, S574, S573, S567, S558, S557, S329, S328, S327, S326, S325, S324, S389, S690, S663, S661, S335, S334, S332, SB239P, SB238, S730P, S729P, S725, S285, SB124, SB110, S647, S464, S448, S434, S909,S853, S847, S731, S475, S474, S472, S4136, SRP227, SRP221, S339, S466, S908, SRP188, SRP187, SB326, SB325, SB323, SB296, SB295, SB294P, SB293, SB292, SB220, SB219, SB218, SB217, SB215, SB214, SB213, SB212, SB209, S476, S468, S467, S4026P, S3916P, S3906L, S503, S754, S848, S641, S636, SRP201, SRP200, SRP199, SRP198, SRP197, SRP196, SRP195, SRP194, S623, S621, SRP230, S674, S667, S547, S919, S918, S632, S631, S630, S628, S737, S622, S352, S3986, S3926, SRP223(c), N/A, N/A, S735, S593, S592, S591, S590, S581, S500, S499P, S740, S852, S734, S732, and S892. *All Dermatome Power Supply units distributed from 3/2/2005 through 4/19/2010 are subject to recall/replacement. According to the firm, certain of the suspect units distributed had no identifiable serial numbers but recall letters were sent to the customers of these units. The firm chose to identify these units as: N/A for the sake of counting the serial numbers of the affected product.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by telephone on March 10, 2011 and letters on March 11, 2011, March 14, 2011 and on April 12, 2011.
Manufacturer: Integra LifeSciences Corp., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.
VOLUME OF PRODUCT IN COMMERCE
1,047 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Unicel� DxH 800 Coulter� Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Part # 629029. Recall # Z-2227-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 12, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.
VOLUME OF PRODUCT IN COMMERCE
673 units total (314 in US)
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom
___________________________________
PRODUCT
Stryker, Impression, Non-Powered Mattress, Model 2980. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress. Recall # Z-2240-2011
CODE
09AC000234, 09AC000235, 09AC000236, 09AC000237, 09AC000238, 09AC000239, 09AC000240, 09AC000241, 09AC000242, 09AC000243, 09AC000244, 09AC000245, 09AC000246, 09AC000247, 09AC000248, 09EA000807, 09EA000808, 09EA000809, 09EA000810, 09EA000811, 09EA000812, 09EA00081, 09EA000814, 09EA000815, 09EA000816, 09EA000817, 09EA000818, 09EA000819, 09EA000820, 09EA000821, 09EA000822, 09EA000823, 09EA000824, 09EA000825, 09EA000826, 09EA000827, 09EA000828, 09EA000829, 09EA000830, 09EA000831, 09FA000833, 09FA000834, 09FA000835, 09FA000836, 09FA000837, 09FA000838, 09FA000839, 09FA000840, 09FA000841, 09FA000842, 09FA000843, 09FA000844, 09FA000845, 09FA000846, 09FA000847, 09FA000848, 09FA000849, 09FA000850, 09FA000851, 09FA000852, 09FA000853, 09FA000854, 09FA000855, 09FA000856, 09FA000857, 09FA000858, 09FA000859, 09FA000860, 09FA000861, 09FA000862, 09FA000863, 09FA000864, 09FA000865, 09FA000866, 09FA000867, 09FA000868, 09FA000869, 09FA000870, 09FA000871, 09FA000872, 09FA000898, 09FA000899, 09FA000900, 09FA000901, 09FA000902, 09FA000903, 09GA000920, 09GA000921, 09GA000922, 09GA000923, 09GA000924, 09GA000925, 09GA000926, 09GA000927, 09GA000928, 09JA001517, 09JA001518, 09JA001519, 09JA001520, 09JA001521, 09JA001522, 09JA001523, 09JA001524, 09JA001561, 09JA001562, 09JA001563, 09JA001564, 09JA001565, 09JA001566, 09JA001567, 09JA001568, 09JA001569, 09JA001570, 09JA001571, 09JA001572, 09JA001573, 09JA001574, 09JA001575, 09JA001576, 09JA001577, 09JA001578, 09JA001579, 09JA001580, 09JA001581, 09JA001582, 09JA001583, 09JA001584, 09JA001585, 09JA001586, 09JA001587, 09JA001588, 09JA001589, 09JA001590, 09JA001591, 09JA001592, 09JA001593, 09JA001594, 09JA001595, 09JA001596, 09JA001597, 09JA001699, 09JA001700, 09JA001701, 09JA001702, 09JA001703, 09JA001704, 09KA002025, 09KA002026, 09KA002064, 09KA002065, 09KA002066, 09KA002067, 09KA002068, 09KA002069, 09KA002070, 09KA002071, 09KA002072, 09KA002073, 09KA002074, 09KA002075, 09KA002076, 09FA000896, 09FA000897, 09AC000249, 09AC000250, 09AC000251, 09AC000252, 09AC000253, 09DA000598, 09DA000599, 09EA000832, 09HA0001046, 09HA0001047, 09HA0001048, 09HA0001049, 09HA0001050, 09HA0001051, 09HA0001052, 09HA0001053, 09HA0001054, 09HA0001055, 09HA0001056, 09HA0001057, 09HA0001058, 09HA0001059, 09HA0001060, 09HA0001061, 09HA0001062, 09HA0001063, 09HA0001064, 09HA0001065, 09HA0001066, 09HA0001067, 09HA0001068, 09HA0001069, 09HA0001070, 09HA0001071, 09HA0001072, 09HA0001073, 09HA0001074, 09HA0001075, 09HA0001076, 09HA0001077, 09HA0001078, 09HA0001079, 09HA0001080, 09JA001698, 09JA001705, 09JA001706, 09JA001707, 09JA001708, 09HA001292 and 09HA001305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated April 29, 2011.  
Manufacturer: Flextronics Ems Ca, L'isletville, Canada. Firm initiated recall is ongoing.
REASON
Affected mattresses may not conform to federal flammability standards.
VOLUME OF PRODUCT IN COMMERCE
213 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
syngo Dynamics version 9.0. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images. Recall # Z-2293-2011
CODE
Units: 10091602, 10091604
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter dated March 24, 2011. Firm initiated recall is ongoing.
REASON
If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
CA, CT, FL, ID, MD, MI, MN, NJ, NY, PA
___________________________________
PRODUCT
Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG). Recall # Z-2294-2011
CODE
Serial Numbers: AB05D000033 AB05F000398 AB05F000405 AB05F000425 AB05F000426 AB05F000430 AB05F000437 AB05F000446 AB05F000448 AB05F000450 AB05F000451 AB05F000456 AB05F000463 AB05F000465 AB05F000466 AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000474 AB05F000482 AB05F000483 AB05F000484 AB05F000485 AB05F000511 AB05F000512 AB05I000666 AB05I000668 AB05I000669 AB05I000670 AB05I000673 AB05I000675 AB05L000906 AB05L000909 AB05L000911 AB05L000920 AB05L000943 AB05L000944 AB05L000945 AB06A000960 AB06A000961 AB06A000964 AB06A000966 AB06A000974 AB06A000987 AB06A000989 AB06A000990 AB06A000994 AB06B001071 AB06B001091 AB06B001093 AB06B001094 AB06B001096 AB06B001110 AB06B001124 AB06B001163 AB06B001181 AB06C001211 AB06C001267 AB06C001275 AB06C001276 AB06C001277 AB06C001336 AB06C001337 AB06C001338 AB06C001339 AB06C001343 AB06C001344 AB06C001346 AB06C001364 AB06D001422 AB06D001431 AB06D001434 AB06D001437 AB06D001439 AB06D001442 AB06D001450 AB06D001582 AB06E001647 AB06E001649 AB06E001650 AB06E001653 AB06E001654 AB06E001708 AB06E001709 AB06F001722 AB06F001723 AB06F001796 AB06F001883 AB06F001914 AB06F001916 AB06G002052 AB06G002057 AB06G002093 AB06G002096 AB06G002099 AB06G002100 AB06G002120 AB06G002124 AB06H002132 AB06H002133 AB06H002134 AB06H002153 AB06H002177 AB06H002264 AB06H002266 AB06I002353 AB06I002363 AB06I002441 AB06I002452 AB06I002539 AB06I002540 AB06I002655 AB06I002673 AB06I002675 AB06I002692 AB06I002695 AB06I002706 AB06I002709 AB06I002715 AB06I002737 AB06J002757 AB06J002778 AB06J002780 AB06J002785 AB06J002786 AB06J002787 AB06J002788 AB06J002789 AB06J002792 AB06J002793 AB06J002797 AB06J002834 AB06J002848 AB06J002850 AB06J002925 AB06J002928 AB06J002929 AB06J002931 AB06L003172 AB06L003204 AB06L003205 AB06L003206 AB06L003209 AB06L003271 AB06L003323 AB07A003370 AB07A003458 AB07A003459 AB07A003460 AB07A003464 AB07A003466 AB07A003470 AB07B003668 AB07B003669 AB07B003672 AB07B003673 AB07C003681 AB07C003690 AB07C003691 AB07C003696 AB07C003699 AB07C003700 AB07C003707 AB07C003708 AB07C003709 AB07C003710 AB07C003716 AB07C003720 AB07C003727 AB07C003921 AB07D003967 AB07D003974 AB07D003976 AB07D003979 AB07D003991 AB07E004157 AB07E004159 AB07E004160 AB07E004180 AB07E004197 AB07E004318 AB07E004391 AB07E004392 AB07E004398 AB07F004436 AB07F004437 AB07F004438 AB07F004439 AB07F004440 AB07F004449 AB07F004471 AB07F004472 AB07F004473 AB07F004474 AB07F004488 AB07F004490 AB07F004563 AB07F004565 AB07F004567 AB07F004568 AB07F004576 AB07F004619 AB07F004621 AB07F004624 AB07F004655 AB07F004735 AB07F004736 AB07G004757 AB07G004773 AB07G004787 AB07G004789 AB07G004799 AB07G004921 AB07G004923 AB07G004927 AB07G004928 AB07G004930 AB07H004999 AB07H005008 AB07H005133 AB07H005139 AB07H005146 AB07I005227 AB07I005231 AB07I005236 AB07I005237 AB07I005240 AB07I005258 AB07I005265 AB07I005395 AB07I005476 AB07I005479 AB07I005484 AB07I005516 AB07I005517 AB07I005585 AB07I005588 AB07I005607 AB07J005689 AB07J005765 AB07J005784 AB07K005881 AB07K005938 AB07L005974 AB07L006036 AB07L006038 AB07L006039 AB07L006040 AB07L006042 AB07L006044 AB07L006045 AB07L006048 AB07L006072 AB07L006075 AB07L006077 AB07L006116 AB07L006117 AB07L006122 AB07L006124 AB07L006126 AB07L006129 AB07L006131 AB07L006154 AB07L006157 AB07L006194 AB08A006246 AB08A006251 AB08A006252 AB08A006258 AB08A006260 AB08A006262 AB08A006290 AB08A006299 AB08A006304 AB08A006306 AB08A006308 AB08A006320 AB08A006322 AB08A006334 AB08A006387 AB08A006392 AB08B006498 AB08B006698 AB08B006704 AB08C006722 AB08C006731 AB08C006732 AB08C006792 AB08C006793 AB08C006813 AB08C006824 AB08C006848 AB08C006887 AB08C006888 AB08C006889 AB08C006916 AB08C006923 AB08C006925 AB08C006934 AB08C006935 AB08C006937 AB08D006955 AB08D006964 AB08D006966 AB08D006967 AB08D006975 AB08D006976 AB08D006978 AB08D006982 AB08D007061 AB08D007069 AB08D007138 AB08D007146 AB08E007227 AB08E007240 AB08E007250 AB08E007412 AB08F007457 AB08F007458 AB08F007459 AB08F007461 AB08F007466 AB08F007476 AB08F007483 AB08F007517 AB08F007530 AB08F007546 AB08F007572 AB08F007590 AB08F007597 AB08F007599 AB08F007604 AB08F007605 AB08F007606 AB08F007612 AB08F007618 AB08F007621 AB08F007626 AB08F007634 AB08F007635 AB08G007698 AB08G007699 AB08G007702 AB08G007707 AB08G007709 AB08G007715 AB08G007719 AB08G007728 AB08G007732 AB08G007758 AB08G007786 AB08G007822 AB08G007835 AB08G007889 AB08G007891 AB08G007897 AB08H007906 AB08H007910 AB08H007993 AB08H008034 AB08H008035 AB08H008039 AB08H008081 AB08H008118 AB08I008171 AB08I008174 AB08I008175 AB08I008187 AB08I008197 AB08I008208 AB08I008210 AB08I008383 AB08I008401 AB08I008434 AB08I008525 AB08I008532 AB08I008624 AB08I008629 AB08I008631 AB08I008640 AB08J008683 AB08J008695 AB08J008696 AB08J008701 AB08J008705 AB08J008836 AB08J008840 AB08J008846 AB08K008863 AB08K008864 AB08K008894 AB08K008896 AB08K008898 AB08K008899 AB08K008900 AB08K008902 AB08K008904 AB08K008909 AB08K008910 AB08K008917 AB08K008919 AB08K008920 AB08K008921 AB08K008922 AB08K008923 AB08K008924 AB08K008928 AB08K008929 AB08K008947 AB08K008948 AB08K008949 AB08K008974 AB08K008979 AB08K008980 AB08K008981 AB08K008982 AB08K009020 AB08K009021 AB08L009133 AB08L009134 AB08L009160 AB08L009169 AB08L009170 AB08L009172 AB08L009184 AB08L009185 AB08L009228 AB08L009230 AB08L009233 AB08L009234 AB08L009250 AB08L009251 AB09A009285 AB09A009286 AB09A009298 AB09A009301 AB09A009303 AB09A009308 AB09A009311 AB09A009312 AB09A009313 AB09A009314 AB09A009315 AB09A009316 AB09A009317 AB09A009318 AB09A009320 AB09A009321 AB09A009322 AB09A009323 AB09A009324 AB09A009325 AB09A009326 AB09A009327 AB09A009339 AB09A009367 AB09A009382 AB09A009390 AB09A009401 AB09A009405 AB09A009406 AB09A009408 AB09A009424 AB09A009499 AB09A009500 AB09A009505 AB09B009591 AB09B009617 AB09B009650 AB09B009658 AB09B009681 AB09B009683 AB09B009684 AB09B009716 AB09B009717 AB09B009718 AB09B009719 AB09B009720 AB09B009721 AB09B009722 AB09B009723 AB09B009724 AB09B009725 AB09B009731 AB09B009864 AB09B009865 AB09C009945 AB09C009965 AB09C009999 AB09C010082 AB09C010218 AB09C010247 AB09C010267 AB09C010348 AB09C010378 AB09C010379 AB09D010534 AB09D010535 AB09D010537 AB09D010538 AB09D010539 AB09D010541 AB09D010544 AB09D010546 AB09D010551 AB09D010553 AB09D010554 AB09D010653 AB09D010654 AB09D010655 AB09D010656 AB09D010657 AB09D010658 AB09D010659 AB09D010731 AB09D010732 AB09D010733 AB09E010766 AB09E010767 AB09E010768 AB09E010769 AB09E010773 AB09E010774 AB09E010775 AB09E010776 AB09E010834 AB09E010848 AB09E010853 AB09E010884 AB09E010885 AB09E010895 AB09E010916 AB09E010917 AB09E010918 AB09E010920 AB09E010921 AB09E010922 AB09E010923 AB09E010925 AB09E010926 AB09E010929 AB09E010930 AB09E010931 AB09E010932 AB09E010933 AB09F011016 AB09F011018 AB09F011027 AB09F011028 AB09F011030 AB09F011031 AB09F011041 AB09F011045 AB09F011046 AB09F011047 AB09F011051 AB09F011053 AB09F011054 AB09F011057 AB09F011059 AB09F011060 AB09F011064 AB09F011066 AB09F011067 AB09F011073 AB09F011082 AB09F011114 AB09F011116 AB09F011118 AB09F011119 AB09F011120 AB09F011212 AB09F011213 AB09F011214 AB09F011215 AB09F011216 AB09F011217 AB09F011219 AB09F011220 AB09F011221 AB09F011222 AB09G011248 AB09G011249 AB09G011250 AB09G011251 AB09G011252 AB09G011271 AB09G011274 AB09G011277 AB09G011278 AB09G011280 AB09H011406 AB09H011456 AB09H011471 AB09I011714 AB09I011715 AB09I011723 AB09I011726 AB09I011727 AB09I011728 AB09I011729 AB09I011730 AB09I011731 AB09I011733 AB09I011974 AB09I011979 AB09I011980 AB09I011981 AB09I011984 AB09I011985 AB09I011989 AB09I011991 AB09I011992 AB09I011993 AB09I011994 AB09I011995 AB09I011996 AB09I011997 AB09I011999 AB09I012000 AB09I012001 AB09I012002 AB09I012003 AB09I012004 AB09I012005 AB09I012006 AB09I012007 AB09I012008 AB09I012009 AB09I012010 AB09I012011 AB09I012058 AB09I012216 AB09I012218 AB09I012227 AB09I012229 AB09I012241 AB09I012242 AB09J012261 AB09J012268 AB09J012271 AB09J012273 AB09J012274 AB09J012276 AB09J012286 AB09J012288 AB09J012291 AB09J012297 AB09J012299 AB09J012301 AB09J012304 AB09J012305 AB09J012306 AB09J012307 AB09J012308 AB09J012309 AB09J012312 AB09J012313 AB09J012314 AB09J012315 AB09J012316 AB09J012318 AB09J012319 AB09J012320 AB09J012321 AB09J012322 AB09J012323 AB09J012324 AB09J012335 AB09K012504 AB09K012506 AB09K012508 AB09K012510 AB09K012511 AB09K012514 AB09K012516 AB09K012533 AB09K012536 AB09K012538 AB09K012541 AB09K012543 AB09K012547 AB09K012549 AB09K012550 AB09K012553 AB09K012688 AB09K012690 AB09K012691 AB09K012692 AB09K012702 AB09K012703 AB09K012706 AB09L012708 AB09L012709 AB09L012710 AB09L012711 AB09L012712 AB09L012713 AB09L012714 AB09L012715 AB09L012805 AB09L012806 AB09L012816 AB09L012822 AB09L012913 AB09L012921 AB09L012968 AB09L012969 AB09L012970 AB09L012971 AB09L012984 AB09L013002 AB09L013003 AB09L013004 AB09L013005 AB09L013010 AB09L013011 AB09L013025 AB09L013027 AB09L013028 AB09L013031 AB09L013032 AB09L013033 AB09L013034 AB09L013035 AB09L013036 AB09L013037 AB09L013038 AB09L013039 AB09L013040 AB10A013051 AB10A013089 AB10A013101 AB10A013125 AB10A013126 AB10A013148 AB10A013154 AB10A013163 AB10A013183 AB10A013185 AB10A013190 AB10A013191 AB10A013197 AB10A013205 AB10A013218 AB10A013221 AB10A013225 AB10A013241 AB10A013245 AB10A013248 AB10A013249 AB10A013250 AB10A013251 AB10A013252 AB10A013253 AB10A013254 AB10A013288 AB10A013289 AB10A013352 AB10A013355 AB10A013356 AB10A013357 AB10A013358 AB10A013359 AB10A013360 AB10A013361 AB10A013362 AB10A013365 AB10A013380 AB10A013384 AB10A013389 AB10B013411 AB10B013417 AB10B013418 AB10B013428 AB10B013438 AB10B013439 AB10B013458 AB10B013459 AB10B013460 AB10B013483 AB10B013540 AB10B013541 AB10B013542 AB10B013544 AB10B013545 AB10B013546 AB10B013547 AB10B013548 AB10B013549 AB10B013550 AB10B013551 AB10B013552 AB10B013553 AB10B013554 AB10B013555 AB10B013561 AB10B013571 AB10B013572 AB10B013574 AB10B013575 AB10B013576 AB10B013577 AB10B013584 AB10B013585 AB10B013586 AB10C013680 AB10C013681 AB10C013683 AB10C013684 AB10C013686 AB10C013688 AB10C013696 AB10C013697 AB10C013698 AB10C013699 AB10C013700 AB10C013701 AB10C013702 AB10C013703 AB10C013704 AB10C013705 AB10C013706 AB10C013708 AB10C013709 AB10C013710 AB10C013711 AB10C013712 AB10C013713 AB10C013715 AB10C013716 AB10C013717 AB10C013718 AB10C013719 AB10C013764 AB10C013765 AB10C013769 AB10C013770 AB10C013887 AB10C013905 AB10C013906 AB10C013918 AB10C013919 AB10C013925 AB10C013986 AB10C014016 AB10C014017 AB10C014019 AB10C014020 AB10C014021 AB10C014022 AB10C014028 AB10C014049 AB10C014055 AB10C014057 AB10C014058 AB10C014060 AB10D014121 AB10D014122 AB10D014123 AB10D014167 AB10D014171 AB10D014174 AB10D014178 AB10D014179 AB10D014182 AB10D014189 AB10D014196 AB10D014217 AB10D014218 AB10D014219 AB10D014220 AB10D014221
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corp., Chelmsford, MA, by letter dated April 22, 2011. Firm initiated recall is ongoing.
REASON
Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy.
VOLUME OF PRODUCT IN COMMERCE
874 units
DISTRIBUTION
Nationwide and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
1) EUKANUBA DOG BG PURE, PURE ADULT LARGE BRD, a) 15 LB, UPC, 0 19014 03959 3; b) 30 LB, UPC, 0 19014 03960 9. Recall # V-128-2011;
 
2) EUKANUBA DOG BG PURE, PURE ADULT MAINTENANCE, a) 4.5 LB, UPC, 0 19014 03958 6; b) 15 LB, UPC, 0 19014 03953 1; c) 30 LB, UPC, 0 19014 03952 4. Recall # V-129-2011;
 
3) EUKANUBA DOG BG PURE, PURE PUPPY GROWTH, a) 4.5 LB, UPC, 0 19014 03949 4; b) 15 LB, UPC, 0 19014 03955 5; c) 30 LB, UPC, 0 19014 09364 7. Recall # V-130-2011;
 
4) EUKANUBA DOG BG PURE, PURE TURKEY, a) 4 LB, UPC, 0 19014 03191 7; b) 15 LB, UPC, 0 19014 03192 4; c) 30 LB, UPC, 0 19014 03193 1. Recall # V-131-2011;
 
5) EUKANUBA DOG CUSTOM CARE, CUSTOM CARE - SENSITIVE SKIN, a) 5.5 LB, UPC, 0 19014 01935 9; b) 28 LB, UPC, 0 19014 01936 6. Recall # V-132-2011;
 
6) EUKANUBA DOG DRY NATURALY WILD, ADULT SALMON & RICE, a) 4 LB, UPC, 0 19014 02780 4; b) 9.5 LB, UPC, 0 19014 02894 8; c) 15 LB, UPC, 0 19014 02781 1; d) 19 LB, UPC, 0 19014 02897 9; e) 30 LB, UPC, 0 19014 02782 8. Recall # V-133-2011;
 
7) EUKANUBA DOG DRY NATURALY WILD, ADULT TURKEY & MULTIGRAIN, a) 4 LB, UPC, 0 19014 02776 7; b) 9.5 LB, UPC, 0 19014 02895 5; c) 15 LB, UPC, 0 19014 02778 1; d) 19 LB, UPC, 0 19104 02898 6; e) 30 LB, UPC, 0 19014 02779 8. Recall # V-134-2011;
 
8) EUKANUBA DOG DRY NATURALY WILD, ADULT VENISON & POTATO, a) 4 LB, UPC, 0 19014 02783 5; b) 9.5 LB, UPC, 0 19014 02893 1; c) 15 LB, UPC, 0 19014 02784 2; d) 30 LB, UPC, 0 19014 02785 9; e) 19 LB, UPC, 019104 02896 2. Recall # V-135-2011;
 
9) IAMS VETERINARY FORMULA CAT DRY BAG, INTESTINAL - LOW RESIDUE, a) 5.5 LB, UPC, 0 19014 15210 0; b) 14 LB, UPC, 0 19014 00859 9. Recall # V-136-2011;
 
10) IAMS VETERINARY FORMULA CAT DRY BAG, OPTIMUM WEIGHT CONTROL D, 5.5 LB, UPC, 0 19014 21305 4. Recall # V-137-2011;
 
11) IAMS VETERINARY FORMULA CAT DRY BAG, RENAL MULTI-STAGE, 5.5 LB, UPC, 0 19014 21405 1. Recall # V-138-2011;
 
12) IAMS VETERINARY FORMULA CAT DRY BAG, URINARY 0 - MODERATE PH/O, 5.5 LB, UPC, 0 19014 15510 1. Recall # V-139-2011;
 
13) IAMS VETERINARY FORMULA CAT DRY BAG, URINARY S - LOW PH/S, a) 5.5 LB, UPC, 0 19014 14210 1; b) 20 LB, UPC, 0 19014 14221 7. Recall # V-140-2011;
 
14) IAMS VETERINARY FORMULA CAT DRY BAG, WEIGHT LOSS RESTRICTED CALORIE, a) 2 KG, UPC, 0 19014 13720 6; b) 18 LB, UPC, 0 19014 02236 6. Recall # V-141-2011;
 
15) IAMS VETERINARY FORMULA DOG DRY BAG, INTESTINAL - LOW RESIDUE, a) 5 LB, UPC, 0 19014 12405 3; b) 30 LB, UPC, 0 19014 12430 5; c) 15 LB, UPC, 0 19014 12415 2 & IAMS VETERINARY FORMULA DOG DRY BAG, INT LOW RESIDUE BREEDER BAG, d) 37 .5 LB, UPC, 0 19014 12437 4, "Best By" Dates, 01Jul10 - 01Dec11 . Recall # V-142-2011;
 
16) IAMS VETERINARY FORMULA DOG DRY BAG, JOINT, a) 6 LB, UPC, 0 19014 21006 0; b) 15 LB, UPC, 0 19014 21015 2; c) 30 LB, UPC, 0 19014 21030 5. Recall # V-143-2011;
 
17) IAMS VETERINARY FORMULA DOG DRY BAG, OPTIMUM WEIGHT CONTROL D, a) 5 LB, UPC, 0 19014 15105 9; b) 15 LB, UPC, 0 19014 15115 8; c) 30 LB, UPC, 0 19014 15130 1. Recall # V-144-2011;
 
18) IAMS VETERINARY FORMULA DOG DRY BAG, PUPPY INTESTINAL LOW RESIDUE, 8 LB, UPC, 0 19014 12908 9. Recall # V-145-2011;
 
19) IAMS VETERINARY FORMULA DOG DRY BAG, RENAL EARLY STAGE, a) 5.5 LB, UPC, 0 19014 14410 5;  b) 15.5 LB, UPC, 0 19014 02235 9. Recall # V-146-2011;
 
20) IAMS VETERINARY FORMULA DOG DRY BAG, SKIN & COAT RESPONSE FP, 6 LB, UPC, 0 19014 12106 9; 15 LB, UPC, 0 19014 12115 1; 30 LB, UPC, 0 19014 12130 4. Recall # V-147-2011;
 
21) IAMS VETERINARY FORMULA DOG DRY BAG, SKIN & COAT RESPONSE KO, a)  6 LB, UPC, 0 19014 21106 7; b) 15 LB, UPC, 0 19014 21115 9; c) 30 LB, UPC, 0 19014 21130 2. Recall # V-148-2011;
 
22) IAMS VETERINARY FORMULA DOG DRY BAG, WEIGHT LOSS RESTRICTED CALORIE, a) 5 LB, UPC, 0 19014 12205 9; b) 14 LB, UPC, 0 19014 12214 1; c) 28 LB, UPC, 0 19014 12228 8. Recall # V-149-2011
CODE
1) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
2) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
3) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
4) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
5) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
6) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11; d) "Best By" Dates, 01Jul10 - 01Dec11; e) "Best By" Dates, 01Jul10 - 01Dec11;
 
7) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11; d) "Best By" Dates, 01Jul10 - 01Dec11; e) "Best By" Dates, 01Jul10 - 01Dec11;
 
8) a) “Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11; d) "Best By" Dates, 01Jul10 - 01Dec11; e) "Best By" Dates, 01Jul10 - 01Dec11;
 
9) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
10) "Best By" Dates, 01Jul10 - 01Dec11;
 
11) "Best By" Dates, 01Jul10 - 01Dec11;
 
12) "Best By" Dates, 01Jul10 - 01Dec11;
 
13) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
14) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
15) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11; d) "Best By" Dates, 01Jul10 - 01Dec11;
 
16) a) “Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
17) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) “Best By" Dates, 01Jul10 - 01Dec11;
 
18) "Best By" Dates, 01Jul10 - 01Dec11;
 
19) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11;
 
20) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
21) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11;
 
22) a) "Best By" Dates, 01Jul10 - 01Dec11; b) "Best By" Dates, 01Jul10 - 01Dec11; c) "Best By" Dates, 01Jul10 - 01Dec11
RECALLING FIRM/MANUFACTURER
Procter & Gamble Co., Mason, OH, by letter on July 25, 2010 and by press release on July 30, 2010.     
Manufacturer: The Iams Co., Lewisburg, OH. FDA initiated recall is ongoing
REASON
FDA found positive results for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,058,476 bags
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Jones Natural Chews Pig Ears Dog Chews; the pig ears were packaged under the following labels and configurations: a) Jones Natural Chews label i) item #00104: 2 pack bag with header card, UPC 7 41956 00104 7, and Pig Outs 2 pk,12 bags per case, UPC 7 41956 00104 4; ii) bulk 100 count box, UPC 7 41956 00113 9; iii) bulk 50 count box, UPC 7 41956 00150 4; iv) bulk 25 count box, UPC 7 41956 00146 7; v) item #00114: 1 pack shrink wrap, UPC 7 41956 00114 6, and Pig Ears 100 per case, UPC 7 41956 00114 3; vi) item #00140, 10 pack printed bag, UPC 7 41956 00140 5, 12 per case, UPC 7 41956 10140 2, and Mills Pig Ears 10 Pk, 12 per case UPC 7 41956 00140 5; b) Country Butcher Dog Chews label i) item #00151, 1 pk shrink wrap, 50 per case, UPC 7 41956 00151 1; ii) item #00114, 1 pk shrink wrap, 30 per case, UPC 7 41956 00114 6; iii) item #00124, 12 pk bag, 12 bags per case, UPC 7 41956 00124 5; c) Blain's Farm & Fleet Pig Ears label, 10 pack bag, UPC 7 41956 00140 5, 12 bags per case, UPC 7 41956 00140 2. Recall # V-150-2011
CODE
Lots 2420, 2490, 2560, 2630, 2700, 2840, 2910 and 2980
RECALLING FIRM/MANUFACTURER
Jones Natural Chews, Inc., Rockford, IL, by press release on March 8, 2011. Washington State initiated recall is ongoing.
REASON
The pig ear dog chews were found to be contaminated with Salmonella bacteria.
VOLUME OF PRODUCT IN COMMERCE
2,705 boxes
DISTRIBUTION
CT, IA, IL, MA, ME, MN, MO, MT, NJ, NM, NY, NC, PA, VA, WA, WI
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT
Evergreen Home Fresh Startgrolay Krumbles Medicated Active Drug Ingredient Amprolium 0.0125% Feeding Directions: Start feeding Evergreen Home Fresh Startgrolay Krumbles as soon as you get the birds. Fill the feeders and place the Startgrolay on paper plates to encourage the chicks to start eating. Five paper plates per 100 birds is sufficient. Place the feed on clean paper plates every day. Gradually remove the paper plates after three days. Feed Evergreen Startgrolay Krumbles unti lthe birds are 10 weeks of age. Startgrolay Krumbles can be used as supplement beginning the 11th week, by adding chopped grains, gradually increasing grain to where birds are consuming 1/2 grain and 1/2 Startgrolay Krumbles. Switch to Evergreen laying feeds at 18-20 weeks of age. Caution: Use As Sole Source of Amprolium. Recall # V-127-2011
CODE
Lot Code: 1511115
RECALLING FIRM/MANUFACTURER
Kent Nutrition Group Inc., Reno, OK, by telephone followed by certified letter or fax on April 28, 2011. Firm initiated recall is ongoing.
REASON
A review of production records showed 75 pounds of an incorrect medicated premix containing chlortetracycline and sulfamethazine was used in this lot.
VOLUME OF PRODUCT IN COMMERCE
230 50-lb bags
DISTRIBUTION
OK, TX
 
END OF ENFORCEMENT REPORT FOR JUNE 1, 2011
 
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