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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 5, 2011

 

 
October 5, 2011                                                                                        11-40
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Watkins SoyNilla, Vanilla Flavored Protein Powder with FiberAid. Net Wt. 7.7 oz. (220 g), Product #22090. Ingredients: Soy protein isolate (providing a minimum of 50 mg isoflavones per serving) & soy protein concentrate, fructose, maltodextrin, rice flour, FiberAid (Registered) (arabinogalactan), natural & artificial flavors, magnesium aspartate, soy fiber, dicalcium phosphate, soy lecithin, Chromium Chelavite (Registered). Recall # F-1821-2011
CODE
Lot # 3000280
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watkins Inc., Winona, MN, by e-mail on August 24, 2011, by letters on August 26, 2011, August 29, 2011 and August 31, 2011 and by press release on September 12, 2011. 
Manufacturers: Watkins Inc., Winona, MN;  
Century Foods International A Division of Hormel Foods Corp., Sparta, WI.
Firm initiated recall is ongoing.
REASON
SoyNilla contains undeclared Milk.
VOLUME OF PRODUCT IN COMMERCE
1,535 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Fresh Hot Basil is also known as lemon or white basil. The product is sold in bulk at grocery stores without labeling or coding. There is no UPC on packages. Recall # F-1822-2011
CODE
No codes. No expiration dates.
RECALLING FIRM/MANUFACTURER
Recalling Firm: M & H Produce, Seattle, WA, by telephone on September 1, 2011 and by fax on September 2, 2011.
Manufacturer: Sanith Ourn dba Asiana Harvest, Indiantown, FL. FDA initiated recall is ongoing.
REASON
Fresh Hot Basil is recalled due to the contamination of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
80 lbs
DISTRIBUTION
WA
___________________________________
PRODUCT
Semi-Soft Cheese, Mini Grayson style, 1 lb square blocks, wrapped in white paper, further packed into foil lined plastic bags. Recall # F-1823-2011
CODE
Unit: MG122-11
RECALLING FIRM/MANUFACTURER
Meadow Creek Dairy, LLC, Galax, VA, by telephone and press release on August 22, 2011. FDA initiated recall is complete.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
12 lbs
DISTRIBUTION
VA
___________________________________
PRODUCT
SunRidge Farms All Natural Milk Chocolate Covered Cranberries. Packaged in a) individual 6.5 oz packages, Item code: 086051, UPC 086700680513; and b) 10 lb bulk boxes, Item Code: 021315; UPC 086700213155. Recall # F-1824-2011
CODE
a) Lot code 0211176; b) lot code 3271003
RECALLING FIRM/MANUFACTURER
Falcon Trading Co., Inc., Pajaro, CA, by press release and letters on September 12, 2011. Firm initiated recall is ongoing.
REASON
Firm received a complaint that a package of SunRidge Farms All Natural Milk Chocolate Cranberries actually contained Milk Chocolate Toffee Peanuts.
VOLUME OF PRODUCT IN COMMERCE
5,452 lbs
DISTRIBUTION
CA, ME MD, MT, NV, PA, AZ, MO, TX, CT, OR, LA
___________________________________
PRODUCT
1) Soy Beginnings, Non-GMO Low-Fat Soy Flour, Net Wt . 40 lbs bags, Product Code for 40# 285100-NFB and Product Code for 1500# 285100-NFT, 1500 lbs totes, NEEDS TO BE FURTHER PROCESSED 2) NexSoy, Certified Non-GMO Low-Fat Soy Flour, Net Wt. 40 lb bags, NEEDS TO BE FURTHER PROCESSED. Recall # F-1825-2011
CODE
1) Lot numbers TF112210, TF102610, and TF102710 2) Lot numbers TF112210 and TF102610
RECALLING FIRM/MANUFACTURER
Thumb Oilseed Producers' Cooperative, Ubly, MI, by letter on September 15, 2011. Firm initiated recall is ongoing.
REASON
The recall resulted from routine sampling programs conducted by the company which revealed salmonella bacteria in the finished product.
VOLUME OF PRODUCT IN COMMERCE
1092 (total for both brand names) 40 lb. bags and 42, 1500 lb. totes
DISTRIBUTION
IL, VT, MN, PA, NH, and Canada
___________________________________
PRODUCT
Yankee Trader Seafood Lobster Spread 7 oz., 5 lb and 30 lb plastic containers. Recall # F-1826-2011
CODE
Lot numbers: Lot #0810lobsp and #0824lobsp Expiration Dates: 09/14/2011 and 09/28/2011
RECALLING FIRM/MANUFACTURER
Yankee Trader Seafood, Ltd, Pembroke, MA, by telephone and follow-up letter on August 30, 2011. Massachusetts initiated recall is complete.
REASON
Undeclared allergens: Undeclared fish, egg and wheat.
VOLUME OF PRODUCT IN COMMERCE
6/30 lb; 4/5lb and 44/7 oz
DISTRIBUTION
RI, MA
___________________________________
PRODUCT
"Dr. Clark Store" Turmeric Powder 1 Cup, Item # 10196-1; Product is a bright yellow granulated powder packaged in a clear flexible plastic ziplock-like bag. The product is a dietary supplement. Label on the product does not indicate intended use.; Product label reads in part: "Dr. Clark Store *** Potent & Pure without excipients *** Dietary Supplement *** Turmeric Powder *** 1 Cup *** Suggested Use: Persons 12 or more years of age take up to 1/4 tsp 3 times daily or as directed by a health professional. Expect yellow stool. *** Warning: If you are pregnant/lactating or have any history of liver, gall-bladder or gastrointestinal problems, please consult a Healthcare Professional prior to use. Recall # F-1827-2011
CODE
Lot Numbers: 10002, 10003, 10115
RECALLING FIRM/MANUFACTURER
Self Health Resource Center, Chula Vista, CA, by e-mail and letters beginning on April 26, 2011 and May 4, 2011. Firm initiated recall is ongoing.
REASON
Products may contain elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
Nationwide and Canada, Japan, Korea, United Kingdom
___________________________________
PRODUCT
FJORD SUPERIOR Norwegian cure Smoked Salmon is produced using only Superior Quality Atlantic Salmon. In the True Norwegian Tradition, the salmon is hand cured and Naturally Smoked***NORWEGIAN CURE***FJORD SUPERIOR Norwegian Cure Smoked Salmon is sliced ready to use. Open the pack and serve at ambient room temperature on a toasted bagel with cream cheese, sliced onions and capers. ***HICKORY HOUSE***". SUPERIOR SMOKED SALMON SLICED RETAIL PACK 4 oz***Ingredients: HighLand farms Atlantic salmon***sugar, sodium nitrite (Preservative) natural hickory smoke***Keep frozen until used. Thaw under refrigeration immediately before use. Package cannot be re-packed in reduced oxygen packaging by the retail***701009 400258***24182***Net Wt 0.25 lb. Product of the USA". Recall # F-1832-2011
CODE
Batch 24182
RECALLING FIRM/MANUFACTURER
Hickory Smokehouse Miami, Inc., Hialeah, FL, by telephone, fax, and e-mail beginning on August 10, 2011. Florida initiated recall is ongoing. 
REASON
Product samples collected and tested by Florida Department of Agriculture tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
25 cases
DISTRIBUTION
Netherlands
________________________________________
PRODUCT
SeaPak Breaded Butterfly Shrimp, Family Size, Net wt. 22 oz (1 lb 6 oz) 623g, Ready-to-Fry breading & seasoning, UPC 100 41322 10254 6, Product Code 10302. The product is sold by the case and each case contains 8 - 22 oz. packages. Recall # F-1834-2011
CODE
Production date of concern is 7/25/2011 with Julian Date of 1003 1206 on the case, "Best By" Date of January 25, 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo, NY, by press release on September 23, 2011.  
Manufacturer: Rich Products Corp., Brownsville, TX. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk (whey) from the coating.
VOLUME OF PRODUCT IN COMMERCE
2,279 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baltic Coast brand Herring Special Salted, 1.3kg - 2.86lb -1300g -- Product of Russia. The product is packaged in a round plastic container. Recall # F-1835-2011
CODE
Code number 20.02.11 PVI44AMIC2
RECALLING FIRM/MANUFACTURER
Recalling Firm: TGF Production, LLC, Brooklyn, NY, by press release and letters dated June 16, 2011.
Manufacturer: Iriada International Ltd., St. Petersburg, Russia. New York initiated recall is complete.
REASON
The imported fish was found to be not properly eviscerated prior to processing based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
40 cases (4 x 1300 g containers per case)
DISTRIBUTION
NY, MA
___________________________________
PRODUCT
Three Rivers brand Golden Raisins, Net wt. 400 gms. Recall # F-1888-2011
CODE
Product is uncoded.
RECALLING FIRM/MANUFACTURER
Shata Trading, Inc., Brooklyn, NY, by press release on July 28, 2011 and letter dated July 28, 2011. New York initiated recall is complete.
REASON
The golden raisins were found to contain undeclared sulfites (816 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY State
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Quick Foods All Natural BEEF KEBAB PITA with Pita Bread, Ground, Beef, Pepper, Salt, Sumac, Lettuce, Tomato, Onion sandwiches in 4 oz and 7 oz packages. Recall # F-1777-2011;
 
2) Quick Foods HONEY MUSTARD CHICKEN BREAST with Bun, 100% Chicken Breast, Provolone, Cheese, Honey Mustard sandwiches in 5.5 oz package. Recall # F-1778-2011;
 
3) Quick Foods Fresh Quality Since 1983 CLASSIC TURKEY SUB with bun, Turkey Breast, Swiss Cheese, Lettuce, Tomato sandwiches in 9 oz plastic packaging. Recall # F-1779- 2011;
 
4) Quick Foods CHICKEN QUESADILLA PITA sandwich with Pita, Chicken, Cheddar, Mozzarella, Taco Spices in 5.5 oz packaging. Recall # F-1780- 2011;
 
5) Quick Foods Fresh Quality Since 1983 CHEESEBURGER with Bun, Beef Patty, American Cheese sandwiches in 4.25 oz packaging. Recall # F-1781-2011;
 
6) Quick Foods Fresh Quality Since 1983 PHILLY BEEF STEAK with Bun, Beef, Provolone Cheese, Onion, Green Pepper, Pepper Seasoning sandwiches in 7 oz plastic packaging. Recall # F-1782-2011;
 
7) Quick Foods Fresh Quality Since 1983 PHILLY SUPER BEEF STEAK with Bun, Beef, Provolone Cheese, Onion, Green Pepper, Pepper Seasoning sandwiches in 9 oz plastic packaging. Recall # F-1783-2011;
 
8) Quick Foods New! Since 1983 BEEF & BIRD sandwiches with Bun, Roast Beef, Turkey, Swiss Cheese in 9 oz plastic packaging. Recall # F-1784-2011;
 
9) Quick Foods Fresh Quality Since 1983 SUPER HAM & CHEESE sandwiches with Sub Bun, Ham, American Cheese in 9 oz plastic packaging. Recall # F-1785-2011;
 
10) Quick Foods Fresh Quality Since 1983 TURKEY & SWISS ON CIABATTA BREAD sandwiches with Ciabatta Bread, Lettuce, Turkey, Swiss in 6 oz plastic packaging. Recall # F-1786-2011;
 
11) Quick Foods CORNED BEEF & SWISS sandwiches with Rye Bread, Corned Beef, Swiss Cheese, Dijon Mustard in 6.5 oz plastic packaging. Recall # F-1787-2011;  
 
12) Quick Foods CORNED BEEF & SWISS sandwiches with Rye Bread, Corned Beef, Swiss Cheese in 7 oz plastic packaging. Recall # F-1788-2011;
 
13) Quick Foods Fresh Quality Since 1983 BBQ BEEF sandwiches with Bun, Beef Patty, BBQ Sauce 6 oz plastic packaging. Recall # F-1789-2011;
 
14) Quick Foods DOUBLE CHEESEBURGER sandwiches with Bun, Beef Patty, American Cheese 7 oz plastic packaging. Recall # F-1790-2011;
 
15) Quick Foods Fresh Quality Since 1983 SKINLESS POLISH SAUSAGE SANDWICH $1.29 sandwiches with Bun, Polish Sausage, American Cheese 4.5 oz plastic packaging. Recall # F-1791-2011;
 
16) Quick Foods Fresh Quality Since 1983 TURKEY PITA sandwiches with Pita Bread, Turkey, Swiss Cheese 7 oz plastic packaging. Recall # F-1792-2011;
 
17) Quick Foods CHICKEN PARMESAN sandwiches with Pita, Chicken, Mozzarella, Pizza Sauce, Provolone Cheese 8 oz plastic packaging. Recall # F-1793-2011;
 
18) Quick Foods CHICKEN & CHEESE sandwiches with Bun, Chicken Patty, American Cheese 6 oz plastic packaging. Recall # F-1794-2011;
 
19) Quick Foods Fresh Quality Since 1983 HAM & CHEESE sandwiches with Sub Bun, Ham, American Cheese in 7 oz plastic package. Recall # F-1795-2011;
 
20) Quick Foods COMBO PITA sandwiches with Pita Bread, Ham, Bologna, Salami, American Cheese, Swiss Cheese in 8 oz plastic package. Recall # F-1796-2011;
21) Quick Foods Fresh Quality Since 1983 CLUB PITA sandwiches with Pita Bread, Ham, Turkey, American Cheese, Swiss Cheese in 6 oz plastic package. Recall # F-1797-2011;
 
22) Quick Foods Fresh Quality Since 1983 TURKEY & SWISS sandwiches with Sub Bun, Turkey, Swiss Cheese in 7 oz plastic package. Recall # F-1798-2011;
 
23) Quick Foods Fresh Quality Since 1983 SUPER ROAST BEEF sandwiches with Bun, Roast Beef, American cheese in 9 oz plastic package. Recall # F-1799-2011;
 
24) Quick Foods Fresh Quality Since 1983 SUPER TURKEY & CHEESE SUB sandwiches with Sub Bun, Turkey, Provolone Cheese in 9 oz plastic package. Recall # F-1800-2011;
 
25) Quick Foods Fresh Quality Since 1983 ITALIAN SUB sandwiches with Sub Bun, Ham, Hard Salami, Provolone Cheese, Pepper Rings, Lettuce, Tomato, Oregano in 7 oz plastic package. Recall # F-1801-2011;
 
26) Quick Foods Fresh Quality Since 1983 SUPER ITALIAN SUB sandwiches with Sub Bun, Ham, Hard Salami, Provolone Cheese, Pepper Rings, Lettuce, Tomato, Oregano in 9 oz plastic package. Recall # F-1802-2011;
 
27) Quick Foods Fresh Quality Since 1983 SUBMARINE sandwiches with Bun, Salami, Bologna, American Cheese, Ham, Pepper Rings in 7 oz plastic package. Recall # F-1803-2011;
 
28) Quick Foods CHICKEN SALAD sandwiches with Wheat Bread, Chicken, Mayonnaise, Celery, Hot Pepper Rings, Salt, Pepper in 6.5 oz plastic package. Recall # F-1804-2011;
 
29) Quick Foods Fresh Quality Since 1983 SUPER DELUXE TURKEY sandwiches with Bun, Turkey Breast, Hard Salami, Provolone Cheese, Lettuce, Tomato, Pepper Rings in 9 oz plastic package. Recall # F-1805-2011;
 
30) Quick Foods Fresh Quality Since 1983 GIANT SUBMARINE sandwiches with Bun, Salami, Bologna, Pepperoni, American Cheese, Ham, Pepper Rings in 10 oz plastic package. Recall # F-1806-2011;
 
31) Quick Foods Fresh Quality Since 1983 CLASSIC ITALIAN ON CIABATTA BREAD sandwiches with Ciabatta bread, Salami, Cappacuolo, Pepper Jack Cheese, Provolone Cheese, Pepper Rings in 7 oz plastic package. Recall # F-1807-2011
CODE
All codes produced 7/26/2011 - 08/10/2011.
RECALLING FIRM/MANUFACTURER
Quick Food Co., Ferndale, MI, by visit on August 3, 2011. FDA initiated recall is ongoing.
REASON
Wheat is used as an ingredient and is not declared on the ingredient declaration. Yellow #5 is used in the pepper rings and is not identified as the ingredient declaration.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
MI
___________________________________
PRODUCT
CBG 1000 (Peptide Bonded Glutamine Powder), Also known as Amino Peptide Blend. 
Recall # F-1819-2011
CODE
Lot # / Manufacture Date Lot 1004 CP = 10/2009 Lot 1005 CP = 04/2010 Lot 1006 CP = 10/2010 Lot 1007 CP = 02/2011
RECALLING FIRM/MANUFACTURER
Commercial Proteins Corp., Lake Arrowhead, CA, by visit on September 19, 2011. FDA initiated recall is ongoing.
REASON
Commercial Proteins Corporation has confirmed CBG 1000 (Peptide Bonded Glutamine Powder) contains the allergen wheat and does not declare wheat on the product label.
VOLUME OF PRODUCT IN COMMERCE
3325 bags, 55lb/bag
DISTRIBUTION
CA, UT, WA, NJ, Poland and England
___________________________________
PRODUCT
1) "Dr. Clark Purity Products" Turmeric Dietary Supplement, Item # 10349-100, 500mg, 100 Capsule bottle; Product is packaged in a white rigid plastic bottle. Label background is of a light gray color. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow.; Product label reads in part: "Turmeric *** Dietary Supplement *** 500mg *** 100 capsules *** Directions: Adults take up to 2 capsules 3 times a day with meals, or as directed by a health professional. Children, 12 and over, take 1 capsule up to 3 times per day with meals, or as directed by a health professional. *** Expect yellow colored stool. *** Keep out of reach of children. *** Store at room temperature *** Supplement Facts *** Serving Size: 2 Capsules ***Serving per container: 50 *** Other ingredients: Easy to swallow gelatin capsules. Does not contain tablet binders, coatings or colorings. Recall # F-1828-2011;
 
2) "Dr. Clark Store Potent & Pure without excipients" Turmeric, Item #10349-100, 500mg, 100 Capsules bottle; Product is packaged in a white rigid plastic bottle. Label background is of a bright yellow color. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow.; Product label reads in part: "Dr. Clark Store *** Potent & Pure without excipients *** Dietary Supplement *** Turmeric *** 500mg *** 100 Capsules *** Suggested use: Persons 12 yore more years of age, take up to 2 capsules 3 times daily or as directed by a health professional. Expect yellow stool. *** This is a whole, fresh, natural ground herb in its purest form. No extraction or chemical process applied. Helps to support a healthy inflammatory response. Warning: If you are pregnant/lactating or have any history of liver, gall bladder or gastrointestinal problems, please consult a Health Professional prior to use. Store this product dry and cool. Keep out of reach of children. Disclaimers: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat a cure, or prevent any disease. Company doesn't adopt any Dr. Clark claims. Supplement Facts *** Serving Size: 2 Capsules *** Servings per container: 50. Recall # F-1829-2011;
 
3) "Dr. Clark Purity" Dr. Clark Quick ParaZap Cleanse, Item#50945-135, 520mg, 135 Capsule bottle; Product is packaged in a box. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow. The product label declares 135 Capsules; Product label reads in part: "Dr. Clark Purity *** Dr. Clark *** Quick ParaZap *** Cleanse *** 2 *** 520mg *** 135 Capsules *** Dietary Supplement *** Dr. Clark Purity *** The Complete Colon Cleanse *** A Complete Colon Cleanse helps maintain optimum health in the entire digestive and urinary system, not only the colon. Complete all four cleanses in this order (1) Digestive Aid Helps maintain healthy pH in stomach (2) ParaZap Cleanse (3) Kidney Cleanse (4) Liver * Gallbladder Cleanse and FLUSH* *** Do not use if safety seal on bottle is broken. Keep out of reach of children. Store in a cool, dry place. Supplement Facts *** Serving Size: 14 Capsules *** Serving Per container: 9 *** Proprietary Blend 7,350mg *** Turmeric *** Black Walnut Hull *** Wormwood *** Anise Seed *** Cardamom Seed *** Coriander Seed *** Fennel Seed *** Cloves. Recall # F-1830-2011
CODE
1) Lot Numbers: 09005, 10006;
2) Lot Numbers: 09031, 10032, 10033;
3) Lot Numbers: 09006, 09007, 10008, 10009
RECALLING FIRM/MANUFACTURER
Self Health Resource Center, Chula Vista, CA, by e-mail and letters beginning on April 26, 2011 and May 4, 2011. Firm initiated recall is ongoing.
REASON
Products may contain elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
1) 5978 units; 2) 655 units; 3) 1663 units
DISTRIBUTION
Nationwide and Canada, Japan, Korea, United Kingdom
___________________________________
PRODUCT
Quon Yick Chinese Dry Noodle, a) Regular and b) Medium sizes. Recall # F-1833-2011
CODE
No code information present.
RECALLING FIRM/MANUFACTURER
Quon Yick Distributors, Inc., El Monte, CA, by letter on September 15, 2011. FDA initiated recall is ongoing.
REASON
Finished product packaging does not declare FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40. All three of these colors are ingredients contained in the noodle products.
VOLUME OF PRODUCT IN COMMERCE
a) 1503-30 lb boxes; b) 903-30 lb boxes
DISTRIBUTION
CO, NM, CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Watkins Original Double Strength Vanilla, 2 Fl. oz. (59 mL), product #21390. Ingredients: Water, glucose, propylene glycol, vanilla extract (alcohol, water, extractive of vanilla beans), alcohol (8.25%), artificial flavors, caramel color. Recall # F-1820-2011
CODE
Lots: 3001497, 3002021, 3003887, 3005241
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watkins Inc., Winona, MN, by e-mail on August 24, 2011, by letters on August 26, 2011, August 29, 2011 and August 31, 2011 and by press release on September 12, 2011. 
Manufacturers: Watkins Inc., Winona, MN;  
Century Foods International A Division of Hormel Foods Corp., Sparta, WI.
Firm initiated recall is ongoing.
REASON
Double Strength Vanilla, 2 oz, is missing a declaration of sulfites.
VOLUME OF PRODUCT IN COMMERCE
1,535 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
"Dr. Clark Purity" Digestive Aid The Quick Colon-Bowel Cleanse, Item # 50951-125, 535mg, 125 capsule bottle; Product is packaged in a box consisting of paper material. The product label declares 125 Capsules. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow.; Product label reads in part: "Dr. Clark Purity *** Quick *** Digestive Aid 1st Step in Colon Cleansing *** 1 *** For optimum results use with cleanse #2 Dr. Clark ParaZap *** 535mg *** 125 Capsules *** Dietary Supplement *** The Complete Colon Cleanse *** A Complete Colon Cleanse helps maintain optimum health in the entire digestive and urinary system, not only the colon. Complete all four cleanses in this order (1) Digestive Aid -Helps maintain healthy pH in stomach (2) ParaZap Cleanse (3) Kidney Cleanse (4) Liver * Gallbladder Cleanse and FLUSH* *** Supplement Facts *** Serving Size: 3 Capsules *** Serving Per container: 41 *** Proprietary Blend 1605mg *** Betaine HCL 945mg *** Papain *** Pepsin *** Turmeric *** Fennel Seed *** Other ingredients: Gelatin capsules. Does not container flow agents, tablet binders, coatings or colorings. *** Dr. Clark Purity *** Chula Vista, California 91911 *** Directions *** Always take with breakfast, lunch and dinner, or as directed by a health care professional. The first day take 1 capsule 3 times. From then on take 3 caps 3 times daily." Recall # F-1831-2011
CODE
Lot Numbers: 10001, 10226
RECALLING FIRM/MANUFACTURER
Self Health Resource Center, Chula Vista, CA, by e-mail and letters beginning on April 26, 2011 and May 4, 2011. Firm initiated recall is ongoing.
REASON
Products may contain elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
656 units
DISTRIBUTION
Nationwide and Canada, Japan, Korea, United Kingdom
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
 
No pending classifications this week.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I 
___________________________________
PRODUCT
SLIM XTREME Herbal Slimming Capsule, 30 capsule bottles. Recall # D-1460-2011
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Globe All Wellness LLC, Hollywood, FL, by press release and email on May 24, 2011.
Manufacturer: Kunming Dali Industry & Trade Co, LTD, Shanghai, China. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, a appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
39,700 bottles
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
1) X-Hero capsules with English label, 1 capsule pack, no UPC Code, 10 capsule bottles, UPC Code: 689087070995; X-Hero capsules with Chinese and/or English Label, 8 capsule bottles, UPC Code: 689076499255. Recall # D-1461-2011;
 
2) Male Enhancer capsules, 60 capsule bottles, UPC Code: 982010061205. Recall # D-1462-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S.A Far Ocean Group LLC, Alhambra, CA, by press release on March 28, 2011 and by letter beginning on April 14, 2011.  
Manufacturer: GuangZhou HeSheng Tang Daily Necessities Co., Ltd., Guangdong, China. Firm initiated recall is ongoing.
REASON
Marketed without an approved NDA/ANDA; FDA lab analysis found product to contain tadalafil, an FDA approved drug used to treat erectile dysfunction (ED), making the product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
111,918 capsules
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Indomethacin for Injection USP, 1 mg, Single Dose Vials, Sterile, Rx only, For the Preparation of IV Solutions, NDC 55390-299-01. Recall # D-1578-2011
CODE
Lot #: 2271-01-1948138, Exp Date 09/11
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc., Bedford, OH, by letters on April 19, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
11,902/1 mg vials
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
__________________________________
PRODUCT
1) First Aid Kits (plastic/metal/softpack) containing recalled Triad alcohol prep pads. Brands include North First Aid Kits, North Safety & Swift, and North by Honeywell. (The following are the Item #s and names on the kits: Item #s : 68200, GALLS REFILL 1ST RESPONDER, Exp. 01/11; 68203, GALLS FILL TRAUMA KIT, Exp. 01/11; 68222, S1111 ANAHEIM UNION LOGO/FAO 222-U, Exp. 01/11; 121054, CPR MICROSHIELD W/2 PR LTX GLV, Exp. 01/11; 121055, MICROSHLD W/LTX GLV /ALCL WIPE, Exp. 01/11; 145225, DELUXE TRAUMA KIT, Exp. 01/11; 148805, EMERGENCY MEDICAL FANNY PACK, Exp. 01/11; 148820, MAJOR TRAUMA KIT, Exp. 01/11; 148835, SURVIVAL PACK FANNY PACK, Exp. 01/11; 154818, ALCOHOL WIPES 50'S, Exp. 01/11; 155818, ALCOHOL PADS TRIAD 70% 100/BX, Exp. 01/11; 156818, ALCOHOL PADS MEDIUM 200/BX, Exp. 01/11; 346100, EMERG. MEDICAL KIT #1 SWIFT, Exp. 01/11; 346200, EMERG. MEDICAL KIT #2 SWIFT, Exp. 01/11; 662100, S0006 HEALER COMP 100 KIT 180 FAK, Exp. 01/11; 6805241, S0005 FA2000 TRUCK KIT FILL/FAK 460, Exp. 01/11; 6808139, S0003 IOWA IRR /FAK 10 UN STEEL, Exp. 01/11; 6810250, DIRECT SAFETY FILL/FAK 36UN ST, Exp. 01/11; 6814260, CITY OF DAYTON FILL/24U MTL FA, Exp. 01/11; 6816650, S0511 MCDONALD'S FILL / LOGO 24 UN, Exp. 01/11; 6842304, A M SUPPLY FILL/FAK 16UN PLSTC, Exp. 01/11; 6885416, AIRGAS REFILL FOR DUNN CONST; Exp. 01/11; 63157998, LSS CPR EMERGENCY KIT, Exp. 01/11; 63158006, LSS #24 ANSI FIRST AID KIT, Exp. 01/11; 64058008, 4646 RADNOR 25 PERSON FIRST AID KIT, Exp. 01/11; 64058013, RADNOR LOGO/420 KIT STEEL, Exp. 01/11; 64058014,RADNOR LOGO/24 UNIT STEEL KIT, Exp. 01/11; 64058022, 4649 RADNOR 16 UN PL TRUCK KIT, Exp.01/11; 64058023,4650 RADNOR 24 UN PL UNITIZED KIT,Exp.01/11; 64058025, 4661 RADNOR 16 UN STL KIT, Exp.01/11; 64058026, 4662 RADNOR 24 STL UNITIZED KIT, Exp. 01/11; 66019720, NORTH COMP 100 PERSON METAL, Exp.01/11; 010019-4320, 4320 24 UN ST KIT ENERGIES LG, Exp. 01/11; 010030-4434, 4434 24 UN PL ALAGASCO KIT, Exp. 01/11; 010057-3142, 3142 24 WH CITY OF ANAHEIM, Exp. 01/11; 010068-4509, 4509 16 WH CITY OF ANAHEIM, Exp. 01/11; 010153-3927, 3927 10 WH BN SANTA FE, Exp. 01/11; 010176-4247, 4247 24 UN METAL ALLIANT ENRGY, Exp. 01/11; 010177-4180, 4180 36 UN STL US AIRWAYS GRND, Exp.01/11; 010177-4248, 4248 36 UN METAL ALLIANT ENRGY, Exp. 01/11; 010183, 36U US AIRWAYS GROUND KIT, Exp. 01/11; 010192-3301, 3301 16 UN STL NASHVILLE ELECT, Exp. 01/11; 010310-2506, 2506 NORTH 10U WH CONTRACTOR, Exp. 01/11; 010310-4141, 4141 10 WH CNTRCTR W/NATIONAL, Exp. 01/11; 010316-2751, 2751 NORTH 16U WH CONTRACTOR, Exp. 01/11; 010316-4142, 4142 16 WH CNTRCTR W/NATIONAL, Exp. 01/11; 010321-2243, 2243 24 WH FISHER SCIENTIFIC, Exp. 01/11; 010324-2507, 2507 NORTH 24U WH CONTRACTOR., Exp. 01/11; 010324-4143, 4143 24 WH CNTRCTR W/NATIONAL, Exp. 01/11; 010336-2507, 2507 NORTH 36U WH CONTRACTOR, Exp. 01/11; 010336-4144, 4144 36 WH CNTRCTR W/NATIONAL, Exp. 01/11; 010370-4470, 4470 36 WH AIRGAS GASPRO, Exp. 01/11; 010385-3079, 3079/1724 10 PL NORTH/VALLEN, Exp.01/11; 010424-4224, 4224 36 UNIT METAL KIT W/PECO LOGO, Exp. 01/11; 010498-3502, 3502 16 WH HAWAIIAN ELECTRIC, Exp. 01/11; 010500-0475, 0475 16 WH HAWAIIAN DREDGING, Exp.01/11; 010552-3305, 3305 16 WH KC STHRN RR, Exp. 01/11; 010710-4078, 4078 24 WH CITY OF NAPERVILLE, Exp. 01/11; 010742-3236, 3236 16 WH N Y MOTOR POOL, Exp. 01/11; 010756-3126, 3126 16 WH NORTHERN ILLINO GAS, Exp.01/11; 010885-4514, 4514 24U CONOCO PHILLIPS, Exp. 01/11; 011011-4165N, 4165 24 WH SOUTHERN COMPANY, Exp. 01/11; 011084-4314, 4314 24 UN STL KIT ELVIN SAFET, Exp.01/11; 011122-3265, 3265 10 WH UCSD-UNIV CA-SN DGO, Exp. 01/11; 011501-4030, 6 WH CPR REGULAR SYSCO 4030, Exp. 01/11; 011542-4293, 4293 36 UN STL INTERNATI PAPER, Exp. 01/11; 011554-1724, DISASTER PREPAREDNESS KIT, Exp. 01/11; 011565-1725, 1725 16 UN STL IBT NORTH LOGO, Exp. 01/11; 011595-1724, 1724 16 PL NORTH SMART KIT, Exp. 01/11; 011598-4336, 4336 16 STL STUFFER COLUMBIA, Exp. 01/11; 011599-4338, 4338 10 UN BLOODBORNE COLUMBIA, Exp. 01/11; 011614-2527A, 2527A 24 UN STL MAGID NORTH, Exp. 01/11; 011623-4358, 4358 MED BULK STL COLUMBIA GAS, Exp. 01/11; 011642, 16U NORFOLK, Exp. 01/11; 011643, 36U NORFOLK, Exp. 01/11; 011670-1726, 1726 36 UN STL FISHER NORTH, Exp. 01/11; 012101-2636, 2636 MEDIUM BULK KIT AIR PROD, Exp.01/11; 012101-2959A, 2959A MEDIUM BULK KIT (#50), Exp. 01/11; 013005-4399, 4399 16U STL A&L UNDERGROUND, Exp. 01/11; 013010, REFILL KIT 013005-4399, Exp. 01/11; 013043-4433, 4433 10 UNIT PL SOUTH DAKOTA, Exp. 01/11; 013061-4454, 4454 24 UNIT STL CEE US, Exp. 01/11; 013087-1725A, 1725A 16 UN 16 STL, Exp. 01/11; 013091-4543, 4543 16U STL VIKING LOGGERS, Exp. 01/11; 013094-4506, 4506 10P PL ABATIX ANSI BULK, Exp. 01/11; 013101-0005L, 0005L 10U STL ATMOS ENERGY W/NORTH, Exp. 01/11; 013103-0008L, 36 UN STL GRAINGER/NORTH KIT, Exp. 01/11; 013104-0008L, 36U PL GRAINGER/NORTH KIT, Exp. 01/11; 013108-4534, 4534 150P CAB MEDSAFE F/A, Exp. 01/11; 013109-4535, 4535 200P DXL CAB MEDSAFE F/A, Exp. 01/11; 013113-4545, 4545 25 PERSON STL FA MEDSAFE, Exp.01/11; 013113-4612, 4612 25 PERSON STL UNIVERSAL LOGO, Exp. 01/11; 013115, 150P REFILL KIT MEDSAFE, Exp. 01/11; 013116, 200P REFILL KIT MEDSAFE, Exp. 01/11; 013134-4374, 4374 10 UN STL PROGRESS ENERGY, Exp. 01/11; 013142-4483, 4483 24 UNIT STL VIKING, Exp. 01/11; 013142-4483, 4483 24 UNIT STL VIKING, Exp. 01/11; 013147-4596, 4596 10 UN STL AIRGAS/ FIRST AID, Exp.01/11; 013161-0008L, 0008L 36 UNIT BPXA KIT W/NORTH LOGO, Exp. 01/11; 014050-4214, SPORTSMAN KIT W/NORTH, Exp. 01/11; 014100-4212, HOME/OFFICE KIT W/NORTH, Exp. 01/11; 015310-3839, 3839 6 WH CPR COM ED LOGO, Exp.01/11; 015451-2596, 2596 16 WH HUNTSVILLE UTILITIE, Exp. 01/11; 016000-0000, 6 DISPOSABLE CPR KIT, Exp. 01/11; 018511-4222, COLUMBIA SOFT PACK W/NORTH, Exp.01/11; 018512-4219, 4219 SOFT PACK PROMOTIONAL RETAIL, Exp/ 01/11; 019000-2396A, 2396A LG FIRST AID CABINET, Exp. 01/11; 019000-4264, 4264 LG CABINET W/VWR INT'L, Exp. 01/11; 019001-0000, DELUXE FIRST AID CABINET 2395, Exp. 01/11; 019001-2395A, 2395A DELUXE FIRST AID CABINET, Exp. 01/11; 019001-4262, 4262 DXL CABINET W/VWR INT'L, Exp. 01/11; 019023, REFILL LG CAB, Exp. 01/11; 019089-3462A , 3462A MED FIRST AID CABINET, Exp. 01/11; 019089-4026, 4026 FIRST AID CABINET SYSCO, Exp.01/11; 019089-4266, 4266 MED FA CABINET VWR INT'L, Exp.01/11; 019642-4366, 4366 16 PL NORFOLK, Exp.01/11; 019643-4367, 4367 36 UN PL NORFOLK, Exp. 01/11; 019651-4375, 4375 24 UN STL AIRGAS/ LUCENT, Exp. 01/11; 019720, REFILL 100P FA STATION NORTH, Exp.01/11; 019720-0009L, 100P CABINET NORTH, Exp. 01/11; 019720-0009L/L, 100P CABINET NORTH LAB, Exp. 01/11; 019720-4489, 4489 100P CABINET VIKING ANSI, Exp. 01/11; 019720-4516, 100P CABINET NORTH, FISHER, Exp. 01/11; 68400LCP, S0681 COLE-PARMER LOGO 400/LN STAN, Exp. 01/11; 68400LEG, S0684 EVERGREEN LOGO/STD FILL W/LINR, Exp. 01/11; 68400LELV, S0006 ELVIN FILL 400L SUPERVAL BLANK, Exp. 01/11; 68400LELVRF, ELVIN FILL 400L SUPERVAL REFIL, Exp. 01/11; 68400LFAPS, S0674 APS FILL/LOGO 400 KIT W/LINER, Exp. 01/11; 68400LFLP, S0006 LAWSON FILL 4 SHELF FAK LOGO, Exp.01/11; 68400LGETZ, GETZ LOGO 4 SHELF STAN W/LINER, Exp. 01/11; 68400LISP, S0699 ISP LOGO/FILL W/LINER 4 SHELF, Exp. 01/11; 68400LISS, S0700 IND.SAFETY LOGO/STD FILL W/LNR, Exp. 01/11; 68400LMAX, SAFETY MAX LOGO/400 STAN-LINER, Exp. 01/11; 68400LMM, S0720 MOBIL MED LOGO 400 STAN LINER, Exp. 01/11; 68400LNODEA, S0006 STANDARD 4 SHELF NO COLD TABS, Exp. 01/11; 68400LNT, S0006 400 KIT WITHOUT TABS W/LINER, Exp. 01/11; 68400LQC, S075 QUAD CITY FILL/LOGO 400 W/LNER, Exp. 01/11; 68400LST, SAFETY 2 DAY LOGO 400L STAN, Exp.01/11; 68400LWAOX, S0723 OXARC-WASH FILL/LOGO 400 LINER, Exp. 01/11; 68400LWS, WILLIAMS SONOMA FILL/FAK 400WL, Exp.01/11; 68400PD, PAYNE & DOLAN SPC/ 4 SH FAK, Exp.01/11; 68400RFNODEA, 1EF.FOR 68-400NODEA NO COLD TB, Exp. 01/11; 68401LRFS, RELIABLE FIRE LOGO/STD 401 KIT, Exp. 01/11; 68401LWAYEST, S0734 WAYEST SAFETY LOGO/STD 401 W/L, Exp. 01/11; 68499AB, ABATIX FILL FAK LOGO SPECIAL, Exp. 01/11; 68600MJ, S0866 MJ HARRIS LOGO 5 SHELF IND FIL, Exp. 01/11; 68600NODEA, 600 XL INDUS./FAK NO COLD TABS, Exp. 01/11; 68600PROAM, S0006 PROAM SPEC FILL 5 SHELF IND FA, Exp. 01/11; 68601FA2, FA2000 LRG IND LOGO + CPR, Exp. 01/11; 6888EFA, EMERGENCY FIRST AID RESPONDER, Exp. 01/11; 682100HERS, HERTZ LOGO/FILL 100 PER, Exp. 01/11; 68300AM, S0371 A & M LOGO/STD FILL W/LINER, Exp. 01/11; 6834180LF, 4883 RITZ LOGO 3 SHELF INDUST W LIN, Exp. 01/11; 6834400LF, 4884 RITZ SAFETY 4 SHELF IND W/LIN, Exp. 01/11; 6834600F, 4885 RITZ LOGO 5 SHELF INDUSTRIAL, Exp. 01/11; 6836TT, TOTAL TOOL SPEC FILL FAK, Exp. 01/11; 68400AM, S0673 A & M LOGO/STD FILL W/LINER, Exp. 01/11; 68400HMYR, HAGEMEYER/ SPC 4 SHELF FAK, Exp. 01/11; 68400LABC, S0671 ABC FIRE LOGO/STD FILL W/LINER, Exp. 01/11; 68400LBB, S0676 BENNETT BOWEN LOGO/400 NO DEA, Exp. 01/11; 64058000, 4641 RADNOR HEAVY INDUSTRIAL STATS, Exp. 01/11; 64058000RF, RADNOR REFILL FOR 5 SHELF, Exp. 01/11; 64058001, 4640 RADNOR HEAVY INDUSTRIAL STATS, Exp. 01/11; 64058001RF, RADNOR REFILL FOR 4 SHELF, Exp. 01/11; 64058004, 4638 RADNOR HEAVY INDUSTRIAL STATS, Exp. 01/11; 64058004RF, RADNOR REFILL FOR 3 SHELF, Exp. 01/11; 6810300, 4847 FA2 LOGO 180 STAN WITH LINER, Exp. 01/11; 6810300FTC, 4847 FORT COLLINS FILL/FA2 LOGO 180, Exp. 01/11; 6810444FTC, 4856 FORT COLLINS FILL/FA2 LOGO 400, Exp. 01/11; 6810662, MCDONALD'S REFILL # 010662, Exp. 01/11; 019720-4516F, 100P CABINET NORTH, FISHER, Exp. 01/11; 019720-4586, 4586 100P CABINET SAFE SITE SUPPLY, Exp. 01/11; 019721, REFILL 150P FA STATION NORTH, Exp. 01/11; 019721-0010L, 150P CABINET NORTH, Exp. 01/11; 019721-4490, 4490 150P VIKING STATION ANSI, Exp. 01/11; 019721-4517F, 150P CABINET NORTH, FISHER, Exp. 01/11; 019721-4586, 4586 150P SAFE SITE SUPPLY, Exp. 01/11; 019722, REFILL 200P FA STATION NORTH, Exp. 01/11; 019722-0011L, 200P CABINET NORTH, Exp. 01/11; 019722-4491, 4491 200P CABINET VIKING ANSI, Exp. 01/11; 019722-4518F, 200P CABINET NORTH, FISHER, Exp. 01/11; 019729-0016L, 10U STL NORTH CONSTRUCTION KIT, Exp. 01/11; 019729-4492, 4492 10U STL VIKING CONSTRUCTION, Exp.01/11; 019730-0017L, 16U STL NORTH CONSTRUCTION KIT, Exp. 01/11; 019730-4493, 4493 16U STL VIKING CONSTRUCTION, Exp. 01/11; 019731-0018L, 24U STL NORTH CONSTRUCTION KIT, Exp. 01/11; 019731-4494, 4494 24U STL VIKING ANSI, Exp. 01/11; 019731-4521, 24U STL NORTH CONSTRUCTION KIT, FISH, Exp. 01/11; 019732-0019L, 36U STL NORTH CONSTRUCTION KIT, Exp. 01/11; 019732-4495, 4495 36U STL VIKING CONSTRUCTION, Exp. 01/11; 019735-0022L, 6U STL NORTH CPR KIT, Exp. 01/11; 019741-0028L, NORTH BITE & STING KIT, Exp. 01/11; 019741-0028L/LA, NORTH BITE & STING KIT, Exp. 01/11; 019751-0020L, 0020L HIP POCKET KIT NORTH, Exp. 01/11; 019751-4393, 4393 HIP POCKET KIT PL VWR, Exp. 01/11; 019751-4501, 4501 COMPACT STAUFFER KIT, Exp. 01/11; 021047, ALCOHOL PREP PADS 10P, Exp. 01/11; 032525, O/H PAK ALCOHOL WIPES 100 PER, Exp. 01/11; 148820RF, MAJOR TRAUMA KIT REFILL, Exp. 01/11; 340410F, TRK KIT STEEL WP FAK LOGO SM, Exp. 01/11; 340410FP, TRK KIT STL WP FAK LOGO W/PUMP, Exp. 01/11; 340460F, TRUCK KIT DELUXE FAK LOGO, Exp. 01/11; 340460FP, S0005 TRUCK KIT DELUXE WP FAK W/PUMP, Exp. 01/11; 34410RF, TRUCK KIT STEEL WP REFILL, Exp. 01/11; 34460RF, REFILL FOR 34-0460 TRUCK KIT, Exp. 01/11; 346200RF, EMERG. MEDICAL KIT 2 REFILL, Exp. 01/11; 34T200, TRAUMA KIT IN DIVIDER BAG, Exp. 01/11; 34TRAM1, FIRST AID KIT TRAUMA #1, Exp. 01/11; 35224AS, ALCOHOL WIPES MEDIUM 100'S, Exp. 01/11; 3524CA, 24 UN STL CONTRACTOR KIT ANSI FAK, Exp. 01/11; 3524CF, 24 UN CONTRACTOR KIT FAK LOGO, Exp. 01/11; 3536CF, 36 UN STL CONTRACTOR KIT FAK LOGO, Exp. 01/11; 35P24CA, S0004 24 UN CONTRACTOR ANSI FAK 24 U, Exp. 01/11; 63111KTSRF, JUMP KIT REFILL, Exp. 01/11; 64058008RF, RADNOR REFILL FOR 25 PERSON KT, Exp. 01/11; 64058013RF, RADNOR LOGO/420 KIT STEEL, Exp.01/11; 64058013V, RADNOR LOGO/16 UNIT STEEL VERT, Exp. 01/11; 64058014RF, RADNOR LOGO/24 UNIT REFILL, Exp. 01/11; 6425RADSPEC, S0578 RADNOR LOGO/FILL #25 (DELTA), Exp. 01/11; 662010G, S0003 HEALER COMP 10 PER STEEL W/GSK, Exp/ 01/11; 662010P, S0003 HEALER COMP 10 PER PLAST W/GSK, Exp. 01/11; 662025P, S0004 HEALER COMP 25 PERSON PLASTIC, Exp. 01/11; 662050P, HEALER COMP 50 PERSON PLASTIC, Exp. 01/11; 66223ANB, FAO 223-AN #25 BULK ANSI/BARR, Exp. 01/11; 663024U, HEALER COMP 24 UNIT STEEL FAK, Exp. 01/11; 66B3304PE, FIRST RESPONDER TRAUMA KIT LG, Exp. 01/11; 66TK023, DYNA MED QUICK RESPONSE REFILL, Exp.01/11; 66TK029, DYNA MED BLS TRAUMA KIT REFILL, Exp.01/11; 67CHPKCPR, CPR KIT FOR SF00001424, Exp. 01/11; 680410MB, MANHATTAN BEACH FILL/FAK 410F, Exp. 01/11; 680460BKF, NO LOGO TRUCK KIT DELUXE,Exp. 01/11; 68058008E, S0931 RADNOR LOGO/25P FILL W/WOVEN, Exp. 01/11; 68058008ERF, REFILL KIT FOR 68058008E, Exp. 01/11; 6810BR, S0131 BELFOR LOGO/HEALER 2010G FILL, Exp. 01/11; 6810MD, S0172 MCDONALD SAFETY 10U STEEL LOGO, Exp. 01/11; 6810PE, S0178 CPR EMERGENCY KIT 10 U STL, Exp. 01/11; 6810PLOGAN, S0182 LOGAN GEN 10 PER PLAST W/GSK, Exp. 01/11; 6810PMD, S0183 MCDONALD SA 10 PER PLAST W/GSK, Exp. 01/11; 6810RH, ROBERT HEELY FILL/DSS LOGO 10U, Exp. 01/11; 6810RSAUTO, S0190 RIVERSIDE LOGO AUTO/ADMIN 10, Exp. 01/11; 6810VAIR, AIRGAS SPEC FILL VEH 10 KIT, Exp. 01/11; 6810WD#2 , S0199 WELDMARK LOGO / FILL 10 UN #2, Exp.01/11; 68120QCS, S0004 QUAD CITY FILL/FAK LOGO 120, Exp. 01/11; 68120RJS, S0004 RJ SAFETY FILL/FAK 120 KIT, Exp. 01/11; 68120RJSRF, RJ SAFETY REFILL FOR 120 KIT, Exp. 01/11; 681212ETJ EMS, TRAUMA JUMP KIT 12X12X10, Exp. 01/11; 68140PANDA, SW002 PANDA EXPRESS FILL/LOGO 140, Exp. 01/11; 68140PANDARF, REFILL FOR 68140PANDA, Exp. 01/11; 68140PROAM, PROAM SPEC FILL 2 SHELF IND FA, Exp. 01/11; 6816PROGE, SW031 PROGRESS ENERGY 16 U STL KIT, Exp. 01/11; 6816SM, S0364 STATE OF MICHIGAN LOGO/FILL 16, Exp. 01/11; 6816WD#2 , WELDMARK LOGO / FILL 16 UN #2, Exp. 01/11; 6816WRIGHT, SW005 WRIGHT BRO LOGO/FILL 16U STEEL, Exp. 01/11; 68180ARB, ARBILL FILL/FIRST AID STATION, Exp. 01/11; 68180LELVB, ELVIN SAFETY BAKERY 180L BLANK, Exp. 01/11; 68180LELVBRF, ELVIN SAFETY BAKERY 180L REFIL, Exp. 01/11; 68180LELVM, ELVIN MEAT DEPT FILL 180L BLK, Exp. 01/11; 68180LELVMRF, ELVIN MEAT DEPT FILL 180 REFIL, Exp. 01/11; 68180LELVRF, ELVIN SAFETY FILL 180L REFILL, Exp. 01/11; 68180NSC 4935, NORTHERN SAFETY #100 BULK KIT, Exp. 01/11; 682010GSSI, S0195 SSI LOGO /FILL 2010G COMP 10 S, Exp. 01/11; 682010PISP, INDUST SAFETY P10 FILL LOGO, Exp. 01/11; 68201TEX, S1076 TEX LOGO/FILL 24 UNIT PLASTIC, Exp. 01/11; 682025PSSI, SSI LOGO /FILL 2025P COMP 25 P, Exp. 01/11; 682025SSI, SSI LOGO /FILL 2025 COMP 25 ST, Exp. 01/11; 682050SSI, SSI LOGO /FILL 2050 COMP 50 ST, Exp. 01/11; 6824ALTEC, S0468 ALTEC FILL/LOG 2 MAN KIT STEEL, Exp. 01/11; 6824CSS#2, S0004 C&S SAFETY FILL/24UN FAK LOGO, Exp. 01/11; 6824FS, S0490 24U STL FILL W/CAL FIRE LOGO, Exp. 01/11; 6824LG, S0504 LACLEDE GAS FILL/LOGO 24U STL, Exp. 01/11; 6824NEI, NEW ELECTRIC FILL/ 24U MT FAK, Exp. 01/11; 6824PROGE, SW032 PROGRESS ENERGY 24 U STL KIT, Exp. 01/11; 6824PROGERF, PROGRESS ENERGY 24 U REFILL, Exp. 01/11; 6824PS, PUGET SAFETY LOGO/24 UNIT FILL, Exp. 01/11; 6824WAY, WAYEST SPEC FILL 24 UNIT FAK, Exp. 01/11; 6824WS, S0004 WINDSTREAM/FAK LOGO 24 UNIT, Exp. 01/11; 6825REC, S0579 RECREONICS FILL/LOGO 25 MAN, Exp. 01/11; 6825SH, S0584 SHARPE SAFETY #25 FILL/LOGO, Exp. 01/11; 6825TT, S0588 TOTAL TOOL FILL/LOGO 25 PER, Exp.01/11; 683024HERS, S0492 HERTZ LOGO/FILL 24U STL, Exp. 01/11; 683036HERS, HERTZ LOGO/FILL 36U STL, Exp. 01/11; 6836ALPD3, S0005 AIRGAS "PAYNE" 36U FILL/FAK #3, Exp. 01/11; 6836CHOC, CHOCTAW KAUL FILL/ 36U ST FAK, Exp. 01/11; 6836JEA, S0638 JACKSONVILLE ELEC FILL & LOGO, Exp. 01/11; 6836JEDUNN, S0639 JEDUNN LOGO/ SPC 36U METAL, Exp. 01/11; 6836M, S0005 MEMCO FILL/FAK 36 UNIT KIT, Exp. 01/11; 68400ARTIC, ARTIC FIRE CUSTOM 4 SHELF IND, Exp. 01/11; 68410GASESP, S0736 GASES PLUS LOGO/410 TRUCK KIT, Exp. 01/11; 68410GETZ, GETZ LOGO 410 STAN FILL (SML), Exp. 01/11; 68420FA22 , S0751 FA2000#2 FILL/LOGO MED TRK KIT, Exp. 01/11; 68460APS, APS LOGO TRUCK KIT DELUXE, Exp. 01/11; 68460GASESP, S0633 GASES PLUS LOGO/460 TRUCK KIT, Exp. 01/11; 68460GETZ, GETZ LOGO 460 STAN FILL (LRG), Exp. 01/11; 68460MM, S0645 MOBIL MED LOGO 460 STAN, Exp. 01/11; 68460SM, S0776 SAFETY MAX LOGO STAN FILL 460, Exp. 01/11; 68460ST, SAFETY 2 DAY LOGO 460 STAN, Exp. 01/11; 68EDRF, KINKOS REFILL KIT FOR 68180ED, Exp. 01/11; 68LAUSDKIT, LAUSD EMERGENCY FIRST AID KIT, Exp. 01/11; 68LAUSDRF, LAUSD REFILL KIT, Exp. 01/11; 68LFFLRF, REFILL FOR #68180LFFL, Exp. 01/11; 68P24AIR, SAIC FILL/LOGO 24 PLAS, Exp. 01/11; 68PRLRF, RE-FILL FOR 68PRLF, Exp. 01/11; 68SOFTPACK, NORTHERN SAFETY SOFTPACK, Exp. 01/11; 69099SC, L. A. UNIF SCH 164751-2, Exp. 01/11; 68180LBR, SW050 BRONER LOGO/STD 180 KIT W/LINR, Exp. 01/11; 68180LDSS, DIRECT SAFETY LOGO/STD 180 W/L, Exp. 01/11; 68180LDUNN, JE DUNN LOGO 3 SHELF HEAVY IND, Exp. 01/11; 68180LEG, EVERGREEN LOGO 180 STAN LINER, Exp. 01/11; 68180LFAPS, S0372 APS FILL/LOGO 180 KIT W/LINER, Exp. 01/11; 68180LFAST, S0392 FASTENAL LOGO 180 STAN W/LINER, Exp. 01/11; 68180LFASTSPEC, FASTENAL LOGO 180 SPEC W/LINER, Exp. 01/11; 68180LFCNS, S0006 NATIONAL SAFETY FILL/FAK 180, Exp. 01/11; 68180LFFL , KROGER FILL/FOOD4LESS LOGO W/L, Exp. 01/11; 68180LGETZ, GETZ LOGO 3 SHELF STAN W/LINER, Exp. 01/11; 68180LISPFA, ISP FILL W/LINER 3 SHELF FAK, Exp. 01/11; 68180LISS, S0404 IND.SAFETY LOGO/STD FILL W/LNR, Exp. 01/11; 68180LK, S0405 KROGER FILL/LOGO 3 SHF W/LINER, Exp. 01/11; 68180LMAX, S0421 SAFETY MAX LOGO/STAN 180-LINER, Exp. 01/11; 68180LMM, S0422 MOBIL MED LOGO 180 STAN LINER, Exp. 01/11; 68180LQC, S0430 QUAD CITY FILL/LOGO 180 W/LNER, Exp. 01/11; 68180LR, S0431 KROGER FILL/RALPH'S LOGO W/LNR, Exp. 01/11; 68180LRFS, RELIABLE FIRE LOGO/STD 180 KIT, Exp. 01/11; 68180LRS, RELIABLE SAFETY LOGO/FILL 180, Exp. 01/11; 68180LS, S0437 KROGER FILL/SMITH'S LOGO W/LNR, Exp. 01/11; 68180LST, S0440 SAFETY 2 DAY LOGO 180L STAN, Exp. 01/11; 68180LTJ, S0442 TRADER JOES FILL & LOGO 180W/L, Exp. 01/11; 68180LWAOX, S0427 OXARC-WASH FILL/LOGO 180 LINER, Exp. 01/11; 68180LWAYEST, S0444 WAYEST SAFETY LOGO/STD 180 W/L, Exp. 01/11; 68180LWHITES, S0447 WHITE SPUNNER LOGO 180 3 SHELF, Exp. 01/11; 68180OCE, SW106 OIL CAPITOL EL LOGO/STD 3 SHLF, Exp. 01/11; 68180SHAW, S0006 SHAW FILL/ 3 SHELF FAK, Exp. 01/11; 68140PRL, PRL FILL/ SPC 2 SHELF FAK, Exp. 01/11; 681800LNT, 3 SHELF IND NO TABS FAK LOGO, Exp. 01/11; 68180ED, S0006 KINKOS FILL/FAK LOGO 3 SHELF, Exp. 01/11; 68180ELVIN, S0387 ELVIN SAFETY LOGO 180 FILL, Exp. 01/11; 68180ENCHANT, S0388 ENCHANTMENT LOGO/STAN 180 FILL, Exp. 01/11; 68180FEDX, S0006 FED X FILL FAK LOGO 180 KIT, Exp. 01/11; 68180FOOD, S0419 OXARC FOOD SERVICE 3 SHELF, Exp. 01/11; 68180FRYS, S0396 FRYS LOGO/3 SHELF KIT, Exp. 01/11; 68180GUCKRF, GUCKENHEIMER SPEC 180 REFILL, Exp. 01/11; 68180LABC, S0369 ABC FIRE LOGO/STD FILL W/LINER, Exp. 01/11; 68120ARB, ARBILL FILL/FAK OFFICE KIT 120, Exp. 01/11; 68140BO, S0242 BOJANGLES FILL & LOGO 140 KIT, Exp. 01/11; 68140BUFF, BUFFET FILL/FAK 2 SHELF KIT, Exp. 01/11; 68140DATA, OCHARLEY'S FILL/DATA-SOURCE KI, Exp. 01/11; 68140FEDX, S0006 FED X FILL FAK LOGO 140 KIT, Exp. 01/11; 68140FLBK, S0267 BURGER KING FILL/LOGO 2 SHELF, Exp. 01/11; 68140FLBKRF, BURGER KING REFILL KIT, Exp. 01/11; 68140FOOD, S0298 OXARC FOOD SERVICE 2 SHELF, Exp. 01/11; 68140LFAPS, APS FILL/LOGO 140 KIT W/LINER, Exp. 01/11; 68140LJEDUNN, S0276 JEDUNN FILL (MEMCO)2 SHLF LOGO, Exp. 01/11; 68499FA22 , FA2000 FILL 499 HANDY KIT FAK, Exp. 01/11; 6850SH, S0660 SHARPE SAFETY #50 FILL/LOGO, Exp. 01/11; 685741A, SHELF RELIANCE KIT "A" ZIP BAG, Exp. 01/11; 685741B, SHELF RELIANCE KIT "B" ZIP BAG, Exp. 01/11; 685741BB, S0821 SHELF RELIANCE KIT "B" LOGO, Exp. 01/11; 685741C, SHELF RELIANCE KIT "C" ZIP BAG, Exp. 01/11; 68600ARTIC, ARTIC FIRE CUSTOM 5 SHELF IND, Exp. 01/11; 686100LONE, LONESTAR SAFETY FILL 6100 BAG, Exp. 01/11; 688805PA, PROAM FILL/EMER.MED.LOGO FANNY, Exp. 01/11; 688820FW, FRED WEBER FILL MAJOR TRAUMA K, Exp. 01/11; 688820IBT, IBT TRAUMA FILL, Exp. 01/11; 6888GATEWAy, GATEWAY FILL / SOFT BAG EM MED, Exp. 01/11; 68AG70, S0005 MJ ELECT FILL/FAK W/MJE DECAL, Exp. 01/11; 68AGT, AIRGAS TRAUMA KIT SPEC. REFILL, Exp. 01/11; 68B3303PRO, PROGRESS ENERGY SPEC FILL RED, Exp. 01/11; 68FA4, MY-BAGS.COM REFILL FA-4, Exp. 01/11; 68FERNOBLS#2, FERNO BLS PLASTIC BAG 12/C #2, Exp. 01/11; 68GS10, NO LOGO RANBERRY FILL 10UN STL, Exp. 01/11; 68GS16, GRANBERRY FILL/BLANK 16UN STL, Exp. 01/11; 68GS36, GRANBERRY FILL/BLANK 36UN TRUK, Exp. 01/11; 68MEDBAG, AIRGAS SPEC FILL MED PLAIN BAG, Exp. 01/11; 68MOD3, LIFESECURE QUICK RESP MOD 3, Exp. 01/11; 68P05241, S0005 FA2000 TRUCK KIT/FAK PLST 460, Exp. 01/11; 68P10ARB, S0003 ARBILL FILL/BULK FIRST AID KIT, Exp. 01/11; 68P10BBL, BENNETT-BOWEN FILL FAK 24 PLAS, Exp. 01/11; 68P10BR, SW047 BRONER LOGO/FILL #10 PLASTIC, Exp. 01/11; 68P10SAFKP, S0003 SAFETYKITSPLUS FILL/16 UNIT PL, Exp. 01/11; 68P10SCHW, S0003 SCHWARZ FILL PLAS BULK FAK, Exp. 01/11; 68P10SF, S0065 FORESTRY LOGO 10U FILL PLASTIC, Exp.01/11; 68P10WEGMANS, WEGMANS FILL/LOGO 10U PLASTIC,Exp. 01/11; 68P16HM#3, S1022 HENKELS-MCCOY FILL & LOGO 16UP, Exp. 01/11; 68P16TREN, S0004 TRENCH-IT FILL 16U PLAST FAK, Exp. 01/11; 68P2010, 10 PERSON PLASTIC FAK LOGO 10P, Exp. 01/11; 68P2025P, 25 PERSON PLASTIC FAK LOGO 16P, Exp. 01/11; 68P24COT, CITY OF TACOMA/ FAK 25 PERSON, Exp. 01/11; 68P24TE, S0004 TEXAS ELECTRIC FILL/FAK 24U PL, Exp. 01/11; 68P25ED, S1082 EQUIP DIR FILL/LOGO 25 PERSON, Exp. 01/11; 68P36DOTFL, FLORIDA DOT FILL/LOGO 36U PLAS, Exp. 01/11; 68P36MCM S1098, MCM CONSTRUCTION FILL PLA LOGO, Exp. 01/11; 68STING, STING KIT IN A ZIP LOCK BAG, Exp. 01/11; 68T200AM, HART SPECIAL FILL T200 KIT, Exp. 01/11; 68T24PROE, SW032 PROGRESS ENERGY TRUCK KIT LOGO, Exp. 01/11; 68T24PROE SW032 PROGRESS ENERGY TRUCK KIT LOGO, Exp. 01/11; 68TK046PSC, DYNAMED DELUXE TRAUMA/02 REFIL, Exp. 01/11; 68VDRA, VOLUNTEER DISASTER RESP. KIT A, Exp. 01/11; 68VDRR, VOLUNTEER DISASTER REPL.ITEMS, Exp. 01/11; 68XS10BT, 10 PERSON FAK IN PLASTIC BOX, Exp. 01/11; 130001CL, BASIC IRK W/54501CBRN, LARGE, Exp. 01/11; 130001CL/LAB, BASIC IRK W/54401CBRN, LARGE, Exp. 01/11; 130001CM, BASIC IRK W/54501CBRN, MEDIUM, Exp. 01/11; 130001CM/LAB, BASIC IRK W/54401CBRN, MEDIUM, Exp. 01/11; 130001CS, BASIC IRK W/54501SCBRN, SMALL, Exp. 01/11; 130001HL, BASIC IRK W/ER2000CBRN, LARGE, Exp. 01/11; 130001HM, BASIC IRK W/ER2000CBRN, MEDIUM, Exp.01/11; 130001HS, BASIC IRK W/ER2000CBRN, SMALL, Exp. 01/11; 130001L, BASIC IRK, LARGE, Exp. 01/11; 130001L/LAB, BASIC IRK, LARGE, Exp. 01/11; 130001M, BASIC IRK, MEDIUM, Exp. 01/11; 130001M/LAB, BASIC IRK, MEDIUM, Exp. 01/11; 130001S, BASIC IRK, SMALL, Exp. 01/11; 130002L, INCIDENT RESPONSE KIT LG, Exp. 01/11; 130002M, INCIDENT RESPONSE KIT MD. Exp. 01/11; 130002S, INCIDENT RESPONSE KIT SM, Exp. 01/11; 130002S/LAB, INCIDENT RESPONSE KIT, Exp. 01/11; 130018CL/LAB, IRK CBRN SUIT TAPE LARGE/LAB, Exp. 01/11; 130018CM, IRK CBRN SUIT TAPE MED, Exp. 01/11; 130018CM/LAB, IRK CBRN SUIT TAPE MEDIUM/LAB, Exp. 01/11; 130018L/LAB, IRK BASIC SUIT TAPE LARGE/LAB, Exp, 01/11; 130018M/LAB, IRK BASIC SUIT TAPE MEDIUM/LAB, Exp. 01/11; 34180F, 3 SHELF INDUSTRIAL FAK LOGO, Exp. 01/11; 34180FB, 3 SHELF INDUSTRIAL W-BBK/FAK, Exp. 01/11; 34180FCP, 3 SHELF IND.W-CPR/FAK & PUMP, Exp. 01/11; 34180FP, 3 SHELF INDUSTRIAL FAK W/PUMP, Exp. 01/11; 34180FPRF, RE-FILL 180 FAK W/PUMP, Exp. 01/11; 34180LB, 3 SHELF IND W/LINER NO LOGO, Exp. 01/11; 34180LFB, 3 SHELF IND W/LINR & BBK/LOGO, Exp. 01/11; 34180LFBP, 3 SHELF IND W/LINR,BBK/FAK PMP, Exp. 01/11; 34180LFC, 3 SHELF IND W/LINR & CPR/LOGO, Exp. 01/11; 34180LFCP, 3 SHELF IND W/LINR & CPR/PUMP, Exp. 01/11; 34180LFP, 3 SHELF IND W/LINER FAK W/PUMP, Exp. 01/11; 34180RF, REFILL FOR 34-180 KIT, Exp. 01/11; 34180RFP, REFILL FOR 34-180 KIT W/PUMP, Exp. 01/11; 34400F, 4 SHELF INDUSTRIAL FAK LOGO, Exp. 01/11; 34400FBP, 4 SHELF IND.W-BBK/FAK & PUMP, Exp. 01/11; 34400FCP, 4 SHELF IND.W-CPR/FAK & PUMP, Exp. 01/11; 34400FP, 4 SHELF INDUSTRIAL FAK W/PUMP, Exp. 01/11; 34400LB, 4 SHELF IND W/LINER NO LOGO, Exp. 01/11; 34400LF, 4 SHELF IND W/LINER FAK LOGO, Exp. 01/11; 34400LFB, 4 SHELF IND W/LINR & BBK/LOGO, Exp. 01/11; 34400LFBP, 4 SHELF IND W/LN/FAK BBK,PMP, Exp. 01/11; 34400LFC, 4 SHELF IND W/LINR & CPR/FAK, Exp. 01/11; 34400LFCP, 4 SHELF IND W/LINR & CPR/PUMP, Exp. 01/11; 34400LFNP, 4 SHELF IND W/LINER FAK NO TAB, Exp. 01/11; 34400LFP, 4 SHELF IND W/LINER FAK W/PUMP, Exp. 01/11; 34400RF, REFILL FOR 34-400 KIT, Exp. 01/11; 34400RFP, REFILL FOR 34-400 KIT W/PUMP, Exp. 01/11; 34401RF, REFILL FOR 34-401 KIT, Exp. 01/11; 34600F, 600 X LRG INDUSTRIAL FAK LOGO, Exp. 01/11; 34600FC, 5 SHELF IND W/LINR & CPR/PUMP, Exp. 01/11; 34600FP, 600 X LG INDUST PUMP FAK LOGO, Exp. 01/11; 34600RF, REFILL FOR XLG INDUSTRIAL 600, Exp. 01/11; 34601F, 600 X LRG INDUSTRIAL FAK LOGO, Exp. 01/11; 34601RF, REFILL FOR XLG INDUSTRIAL 601, Exp. 01/11; 3536CA, 36 UN CONTRACTOR KIT ANSI FAK, Exp. 01/11; 63157989, LSS CPR EMERGENCY KIT, Exp. 01/11; SF00002012, S0002 16U MT ASPLUNDH TREE FILL, Exp. 01/11; SF00002062, 4909 10U PL LITTLE LEAGUE LOGO/FILL, Exp. 01/11; SF00002071, 3839 6UN COM ED CPR FILL/LOGO, Exp. 01/11; SF00002079, REDICARE MED BAG NO LOGO, Exp. 01/11; SF00002081, 4914 16UN MT CABLEVISION FILL, Exp. 01/11; SF00002087, 4918 16U MT NPL CONSTR WESCO FILL, Exp. 01/11; SF00002089, WEATHERFORD SURVIVAL FANNY PACK KIT, Exp. 01/11; SF00001914, BLUEGRASS TRAUMA BAG, Exp. 01/11; SF00001915, 4853 24UN MT MLGW FILL & LOGO, Exp. 01/11; SF00001925, REFILL FOR GRAINGER #3EWK5 4 SHELF, Exp. 01/11; SF00001932, PUBLIC SAFETY BLS REFILL, Exp. 01/11; SF00001942, 4864 6UN MT STND CPR KIT NYC ENVIROM, Exp. 01/11; SF00002008, 6UN MT CPR NO LOGO INLAD TRUCK&VAN, Exp. 01/11; SF00002010, S0002 16U MT ASPLUNDH TREE FILL, Exp. 01/11; SF00001321, 4714 3 SHELF STD FILL LAWSON LOGO, Exp. 01/11; SF00001322, 4715 4 SHELF LAWSON, Exp. 01/11; SF00001368, 10U RPD LBL TRUCK KIT FILL, Exp.01/11; SF00001371, S0003 16U PL AIRGAS FILL, Exp. 01/11; SF00001411, 0010L 3 SHLF GRAINGER RAPID LB LOGO, Exp. 01/11; SF00001420, 0010L 3 SHLF GRAINGER FILL, Exp. 01/11; SF00001424, 4726 36U MT CHESAPEAKE ENERGY LOGO, Exp. 01/11; SF00001434, S0006 3 SHLF PLANT KIT LONE STAR, Exp. 01/11; SF00001463, 0009L 2 SHLF GRAINGER FILL, Exp. 01/11; SF00001504, 4744 24U MT WELDMARK LOGO/FILL, Exp. 01/11; SF00001528, 4732 24U MT FPL LOGO/FILL, Exp. 01/11; SF00001537, S0006 3 SHLF ELVIN SAFETY FILL, Exp. 01/11; SF00001537, S0006 3 SHLF ELVIN SAFETY FILL, Exp. 01/11; SF00001564, S0004 24U MT GRAINGER FILL, Exp. 01/11; SF00001688, S0006 3 SHLF ARTIC FIRE FILL, Exp. 01/11; SF00001731, 4807 36U MT FILL NJ DOT LOGO/FILL, Exp. 01/11; SF00001740, S0005 36U MT THERMO FISHER FILL, Exp. 01/11; SF00001748, REFILL FOR SF00001685 BIGGE CRANE, Exp. 01/11; SF00001759, 4812 24U MT TEICHERT LOGO/FILL, Exp. 01/11; SF00001818, MJR TRAUMA BAG LIBRA SAFETY FILL, Exp. 01/11; SF00001851, S0004 24U PL GALLS FILL, Exp. 01/11; SF00001853, 4914 16U MT CABLEVISION, Exp. 01/11; SF00001889, REDI CARE LRG. CITY IF JACKSON, Exp. 01/11; SF00000034, 10 UNIT CITY OF MOUNTAIN VIEW FILL, Exp. 01/11; SF00000274, S1051 SSI LOGO FILL2025P 682025PSSI, Exp. 01/11; SF00000302, TRAUMA KIT IN RED FANNY PK 11"X7"X5", Exp. 01/11; SF00000327, S0005 FA LOGO/#36 MT TOTAL TOOL FILL, Exp. 01/11; SF00000334, 4634 16UN MT ARMY CORP FILL/LOGO, Exp. 01/11; SF00000414, S0006 FA LOGO 4 SHELF CABINET HNA, Exp. 01/11; SF00000471, S0905 SSI LOGO FILL H 2200 682200SSI, Exp. 01/11; SF00000474, S0905 SSI LOGO STD 3SH IND 180KIT, Exp. 01/11; SF00000491, PERSON PACK HAGEMEYER FILL, Exp. 01/11; SF00000506, 4643 HIP POCKET KIT W/FRUCON LOGO, Exp. 01/11; SF00000657, S0005 FA LOGO 36U METAL SPI FILL, Exp. 01/11; SF00000660, 24UNIT MTL FP&L FILL, Exp. 01/11; SF00000664, 4712 16UN MT COACH&EQUIPMENT FILL, Exp.01/11; SF00000726, DEL RIO EMERGENCY KIT RED DUFFLE, Exp. 01/11; SF00000763, 150P CABINET NORTH,FIND MRO MODIFIED, Exp. 01/11; SF00000768, S0006 FA LOGO 4SHF USPS FILL, Exp. 01/11; SF00000813, S0006 FEDEX LOGO 2 SHELF FEDEX FILL, Exp. 01/11; SF00000842, SW153 3SHELF HAGEMEYER LOGO L&P FILL, Exp. 01/11; SF00000849, S0006 FA LOGO 3 SHLF ANTHOINE RUBBER, exp. 01/11; SF00000853, REFILL FOR RITZ KIT# 6834600F, Exp. 01/11; SF00000903, SHERIFF FILL IN DUFFLE BAG, Exp. 01/11; SF00000941, 16U MT GRAINGER FILL, Exp. 01/11; SF00000941, 16U MT GRAINGER FILL, Exp. 01/11; SF00000955, S0006 FA LOGO 3 SHELF Z0160 FILL, Exp. 01/11; SF00000972, 4670 WARDS NURSING, Exp. 01/11; SF00001022, S0004 24U PL CITY OF RALEIGH FILL, Exp. 01/11; SF00001068, S075 400 W/LINER QUAD CITY FILL/LOGO, Exp. 01/11; SF00001088, S0006 3SHLF IND WAREHOUSE CARE SAFET, Exp. 01/11; SF00001096, S1022 16U PL HENKELS-MCCOY FILL, Exp. 01/11; SF00001109, SM NYLON BAG SURVIVAL AIRGAS FILL, Exp. 01/11; SF00001113, EMER MED BG 8X8X6 AIRGAS FILL, Exp. 01/11; SF00001129, SW163 3SHLF W/LINER STND FILL/BELFOR, Exp. 01/11; SF00001140, S0003 10UN MT CITY OF MOUNTAIN VIEW, Exp. 01/11; SF00001141, S0004 24UNT MT CITY OF MOUNTAIN VIEW, Exp. 01/11; SF00001214, SURVIVAL BAG GASES PLUS, Exp. 01/11; SF00001240, 4695 16UN MT ORANGE COUNTY FILL/LOGO, Exp. 01/11; SF00001241, 4696 36UN MT ORANGE COUNTY FILL/LOGO, Exp. 01/11; SF00001253, 4683 16U MT NICOR WESCO FILL, Exp. 01/11; SF00001255, AIRGAS PPE POLYBAG FILL, Exp. 01/11; SF00001300, S0006 2 SHLF GRAINGER FILL, Exp. 01/11; SF00001305, S0006 3SHLF ALYESKA PIPELINE FILL, Exp. 01/11. Recall # D-1458-2011;
 
2) Repacked Triad Alcohol Prep Pads (brands include North First Aid Kits, North Safety & Swift, and North by Honeywell) with the following Item #s and names: a) 720374T, Alcohol Prep Pads, Bulk; b) 155818, Alcohol Prep Pads100 Pack; c) 156818, Alcohol Prep Pads 200 Pack; d) 240820, Bulk Alcohol Prep Pads 3000/CS; e)154818, Alcohol Prep Pads 50'S; f) 021047,Alcohol Prep Pads 10/Pack; g) 021057, Alcohol Prep Pads 50/Pack; h) 35224AS, Alcohol Prep Pads 100 Pack, and i) 032525, Alcohol Prep Pads 100 Box. Recall # D-1459-2011
CODE
1) All lots;
 
2) a) Exp. 01/11; b) Exp. 01/11; c) Exp. 01/11; d) Exp. 01/11; e) Exp.01/11; f) Exp. 01/11; g) Exp. 01/11; h) Exp. 01/11; i) Exp. 01/11. All lots were manufactured from 01/01/2008 through 01/06/2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: North Safety Products, Inc., Cranston, RI, by email and fax on January 13, 2011.
Manufacturers: H & P Industries, Inc., Hartland, WI;
North Safety Products (dba Swift First Aid), Mexicali, Mexico. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Product: North Safety Kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential bacillus cereus. contamination.
VOLUME OF PRODUCT IN COMMERCE
844,868 kits
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Dow Corning Q7-2587 and Q7-2587N (both generally referred to as Q7-2587), 30% Simethicone Emulsion USP, Caution for further Manufacturing, Processing and Repacking. AVOID FREEZING. Recall # D-1577-2011
CODE
0006069707, 0006149739, 0006069708, 0006196492, 0006069709, 0006196493, 0006069711, 0006196494, 0006069712, 0006196496, 0006080715, 0006212095, 0006080716, 0006212097, 0006085086, 0006215410, 0006085087, 0006215411, 0006099045, 0006215412, 0006099046, 0006221786, 0006099047, 0006221788, 0006104719, 0006223129, 0006104723, 0006245087, 0006104725, 0006245088, 0006104731, 0006245089, 0006125019, 0006245090, 0006125022, 0006276742, 0006125030, 0006276743, 0006125032, 0006276744, 0006125036, 0006283390, 0006125041, 0006285606, 0006135924, 0006285607, 0006135925, 0006296408, 0006135926, 006296410, 0006135927, 0006296412 and 0006314980
RECALLING FIRM/MANUFACTURER
Dow Corning Corporation Healthcare Industries Materials Site, Hemlock, MI, by e-mail on December 14, 2010 and December 21, 2010 and by letter on July 20, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non Sterile Product; mold found in gasket area of drum lid.
VOLUME OF PRODUCT IN COMMERCE
558 units
DISTRIBUTION
CA, SC, MI, NE, AL, PA, MA, Canada, Mexico, Germany and UK
__________________________________
PRODUCT
Non-Sterile Alcohol Prep Pads/Swabs, saturated with 70% v/v Isopropyl Alcohol, distributed under the following labels, sizes and codes: a) PDI Alcohol Prep Pad, MEDIUM, For Professional and Hospital Use, 200 Packets (pads) per box, NDC 10819-3912-1, 10 x 200s, 15 x 200s, 3000 pads; a-c) PDI Item #s B-33901, B33905, B33973, B68870, C29600; b) PDI Alcohol Pads, medium, 100 Individually Foiled Wrapped Pads per box, NDC 10819-3912-3, UPC 0 74887 10050 4; c) PDI Alcohol Prep Pad, LARGE, For Professional and Hospital Use, 100 Packets (pads) per box, NDC 10819-3912-2; d) McKesson Medi-Pak Alcohol Prep Pads - MEDIUM, Non-Sterile, Single Use, Latex-Free, 200 Packets (pads) per box, NDC 68599-5805-1, McKesson Medi-Pak Item #s B-85637, Reorder No. 58-104; e) McKesson Medi-Pak Alcohol Prep Pads - LARGE, Non-Sterile, Single Use, Latex-Free, 100 Packets (pads) per box, NDC 68599-5805-2, McKesson Medi-Pak Item # C42500, Reorder No. 58-304; f) Medichoice Alcohol Prep Pads, MEDIUM, Non-Sterile, Single Use, Latex-Free, 200 Packets (pads) per box, NDC 65517-00021, Medichoice Item #s B91437 and C73400; Reorder # 4725APP101, g) Medichoice Alcohol Prep Pads, LARGE, Non-Sterile, Single Use, Latex-Free, 100 Packets (pads) per box, NDC 65571-00021, Medichoice Item # C73400, Reorder # 4725APP103; h) ProAdvantage Non-Sterile Alcohol Prep Pads, Medium, For Professional and Hospital Use, 200 Packets (pads) per box, NDC 43128-3910-2, ProAdvantage Item #s B34700; i) ProAdvantage Non-Sterile Alcohol Prep Pads, Large, For Professional and Hospital Use,100 packets (pads) per box, NDC 43128-3910-1, ProAdvantage Item #C36100; j) Duane Reade Alcohol Prep Swab,100 Swabs per box, UPC 6 39194 00694 1, Duane Reade Item # B81071; k) ShopRite Alcohol Prep Swabs,100 Swabs per box, UPC 0 41190 20995 4, ShopRite Item # B32071. Recall # D-1579-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Professional Disposables International, Inc., Orangeburg, NY, by letters dated September 16, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The non-sterile alcohol prep pads/swabs were found to be contaminated with Bacillus cereus based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
285,478,600 Packets (Pads)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Cramer #111100, Trainer's Kit Refill, packaged in a shipping box labeled with the bar code 3 11960 51530 6, Cramer Products, Gardner, Kansas 66030. The kit includes 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, Triad Disposables, Inc., Brookfield, WI 53045, as well as other components not listed. Recall # D-1580-2011;
 
2) Cramer #111300, Pro Soft Sided Equipped Kit, black nylon bag with a rip-stop front packaged in a shipping box labeled with the bar code 3 11960 64079 4. The kit contains the #111100 Trainers Kit Refill, which includes 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1581-2011;
 
3) Cramer #111700, Deluxe JR Varsity Equipped Kit, black plastic box packaged in a shipping box labeled with the bar code 3 11960 664679 6. The kit contains 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1582-2011;
 
4) Cramer #111800, Junior Soft Sided Equipped Kit, black nylon bag with a rip-stop front packaged in a shipping box labeled with the bar code 3 11960 64379 5. The kit contains the #111100 Trainers Kit Refill, which includes 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1583-2011;
 
5) Cramer #112000, Retail First Aid Kit, white plastic case with a built in handle, containing 3 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1584-2011;
 
6) Cramer #111900, Super Soft Sided Equipped Kit, black nylon bag with a rip-stop front packaged in a shipping box labeled with the bar code 3 11960 64479 2. The kit contains the #111100 Trainers Kit Refill, which includes 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1585-2011;
 
7) Cramer #112600, Varsity Equipped Kit, black steel kit with the Cramer logo packaged in a shipping box labeled with the bar code 3 11960 64779 3. The kit contains the #111100 Trainers Kit Refill, which includes 1 ziplip bag containing 16 pads per kit of Povidone Iodine Prep Pads, 10% Povidone Iodine, USP, Cat. No. 10-3201, NDC 50730-3201-1, as well as other components not listed. Recall # D-1586-2011
CODE
1) Lot #s: LUB056, LUK475, LVB093, LVD171, LVI330, LVI332, LVI333, LVI352, LVI354, LVI355, LWB065, or any other lot found to contain Povidone Iodine Pads;
 
2) Lot #s: LUK477, LVC116, LVI335, or any other lot found to contain Povidone Iodine Pads manufactured by Triad
 
3) Lot #s: LVB043, LVB044, LVI345, LUG333, LVH317, or any other lot found to contain Povidone Iodine Pads manufactured by Triad;
 
4) Lot #s: LUK476, LVG261, or any other lot found to contain Povidone Iodine Pads manufactured by Triad;
 
5) Lot #s: LUI403, LVC127, LVC129, LVG280, or any other lot found to contain Povidone Iodine Pads manufactured by Triad;
 
6) Lot #s: LUC118, LVC118, LVL426, LVI336, or any other lot found to contain Povidone Iodine Pads manufactured by Triad;
 
7) Lot #s: LVL427, LVI331, or any other lot found to contain Povidone Iodine Pads manufactured by Triad.
RECALLING FIRM/MANUFACTURER
Cramer Products Inc., Gardner, KS, by e-mail letter, fax or telephone on March 28, 2011 and April 7, 2011 and by letter beginning August 15, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: Products contain povidone iodine prep pads which were recalled by their supplier.
VOLUME OF PRODUCT IN COMMERCE
4,489 kits
DISTRIBUTION
Nationwide, Puerto Rico, Canada, and Bermuda
__________________________________
PRODUCT
Fluoxetine Capsules USP, 20 mg, 1000-count bottle, Rx only, NDC 16714-352-02. Recall # D-1605-2011
CODE
 Lot #: 1A14009MA, Exp 12/12
RECALLING FIRM/MANUFACTURER
Alembic Limited, Formulation Division, Village Panelav, Gujarat, India, by e-mail on September 23, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablet; A capsule of Fluoxetine 40mg was found in a bottle of Fluoxetine 20mg.
VOLUME OF PRODUCT IN COMMERCE
1,900 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III 
___________________________________
PRODUCT
1) Sea Breeze Actives, with 1% Salicylic Acid Acne Treatment, Deep-Clean Astringent, packaged in a) 10-fl. oz. and b) 16-fl. oz bottles, UPC #: a) 827755030201, b) 827755030249. Recall # D-1587-2011;
 
2) Sea Breeze Actives, with 2% Salicylic Acid Acne Treatment, Clear-Pore Astringent, packaged in 10-fl. oz bottles, UPC#: 827755030225. Recall # D-1588-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Marianna Industries Inc., Omaha, NB, by telephone on April 8, 2011 and email on April 12, 2011. Firm initiated recall is complete.
REASON
Labeling Illegible: Lot coding and expiration dates were illegible on some containers.
VOLUME OF PRODUCT IN COMMERCE
349,164 bottles
DISTRIBUTION
MS
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1888-11
CODE
Unit: GG42474
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone and facsimile on October 31, 2007 and November 7, 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
1) Red Blood Cells. Recall # B-1965-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1966-11
CODE
1) Unit: W088411516204;
2) Unit: W088411401736
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter on August 3, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2089-11
CODE
Unit: 53FF86877
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by electronic mail on May 28, 2011. Firm initiated recall is complete. 
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2091-2011
CODE
Unit: W035811104673 (part 1); W035811104673 (part 2)
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and facsimile on June 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-2092-11
CODE
Units: AU0016260; AU0016607; AU0026522; AU0026666
RECALLING FIRM/MANUFACTURER
DCI Biologicals Austin, LLC, Austin, TX, by facsimile on June 11, 2011 and electronic mail on July 21, 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
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2093-11
CODE
Units: W227710071425; W227711401748; W227710071807
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on July 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2094-11
CODE
Unit: W227710350917
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on January 23, 2011 and electronic mail on July 6, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-2095-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2096-11
CODE 
1) Unit: W04201102731900 (part 3);
2) Units: W04201102731900 (part 1); W04201102731900 (part 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone and facsimile on June 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2098-11
CODE
Unit: 53G18699
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by electronic mail on June 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2123-11
CODE
Unit: W089811003430
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by telephone on June 20, 2011 and by letter on June 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who previously tested repeat reactive for anti-HTLV-I/II was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2140-11
CODE
Units: 01FH14774 (part 1); 01FH14774 (part 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, West Henrietta, NY, by facsimile on June 15, 2011.
Manufacturer: The American National Red Cross, Albany, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2141-11
CODE
Units: W047011066570A; W047011066570B
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY, by letter on July 12, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced but did not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2147-11
CODE
Unit: W050911025267
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by facsimile and telephone on May 23, 2011, and by follow-up letter on May 24, 2011 and August 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2149-11
CODE
Unit: LJ90080
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated September 14, 2006. 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
Platelets Pheresis Leukocytes Reduced. Recall # B-2150-11
CODE
Unit: LV12851
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated October 16, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2151-11
CODE
Unit: FM95448
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on December 26, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2152-11
CODE
Unit: FM08084
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on December 19, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2154-11;
2) Recovered Plasma. Recall # B-2155-11
CODE
1) and 2) Unit: LM89139
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on December 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2156-11;
2) Recovered Plasma. Recall # B-2157-11
CODE
1) and 2) Units: W038611334841
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by facsimile on July 19, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2158-11
CODE
Unit: 16GP90698
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on July 20, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2159-11
CODE
Unit: W038111061703
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers – Lake Park, Palm Beach Gardens, FL, by letter on July 19, 2011.
Manufacturer: Florida’s Blood Centers – Miramar, Miramar, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2160-11
CODE
Unit: 042FR67826
RECALLING FIRM/MANUFACTURER
American National Red Cross, Cleveland, OH, by fax on June 21, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Antihemophilic Factor (Recombinant). Recall # B-2165-11
CODE
Unit: TRA09834AB
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Thousand Oaks, CA, by letter dated July 25, 2011. Firm initiated recall is ongoing.
REASON
Antihemophilic Factor (Recombinant), manufactured with a potential breach in asceptic processing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) MEDITECH Blood Bank Software MAGIC 5.6 Release. Recall # B-2167-11;
2) MEDITECH Blood Bank Software Client Server 5.6, 6.0 and 6.1. Recall # B-2168-11
CODE
1) MAGIC 5.6 Release;
2) Client Server 5.6, 6.0 and 6.1
RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mail task updates on May 3, 2011. Firm initiated recall is complete.
REASON
Software, with a glitch or defect which could lead to an incompatible unit being transfused, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1) 391; 2) 298
DISTRIBUTION
Nationwide, Canada, UK
___________________________________
PRODUCT
1) MEDITECH Blood Bank Software MAGIC 5.63 and 5.64. Recall # B-2169-11;
2) MEDITECH Blood Bank Software Client Server 5.65, 6.05 and 6.06. Recall # B-2170-11
CODE
1) Versions 5.63 and 5.64;
2) Client Server 5.65, 6.05 and 6.06
RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mail task updates on July 15, 2011. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect which could lead to an incompatible unit being transfused, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1) 354; 2) 274
DISTRIBUTION
Nationwide, Canada, UK, South Africa
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2179-11
CODE
Unit: LV28691
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by e-mail on March 2, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B -2183-11
CODE
Units: LJ42667, LJ65018
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated March 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B -2184-11
CODE
Unit: LV02722
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated March 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1887-11
CODE
Unit: GG42474
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone and facsimile on October 31, 2007 and November 7, 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
Platelets Pheresis Leukocytes Reduced, Recall # B-1968-11
CODE
Units: FN34838, FN28547, FN33076 (part 1), FN33076 (part 2)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Source Plasma. Recall # B-2081-11
CODE
Units: 5130060159; 5130058994; 5130058656; 5130057508; 5130056394; 5130056031; 5130054812; 5130054626; 5130053693; 5130053442; 5130050399; 5130050190
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Portsmouth, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-2082-11
CODE
Units: 5130049431; 5130048162
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Portsmouth, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-2083-11
CODE
Units: 5130034326; 5130033780; 5130033160; 5130032756
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Portsmouth, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-2084-11
CODE
Units: 5020100789; 5020098770; 5020098368; 5020097725; 5020095595; 5020095268; 5020094695; 5020087185; 5020085855; 5020085376; 5020083461; 5020082789; 5020112706; 5020112071
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Omaha, NB, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2085-11
CODE
Units: 5020061871; 5020085632; 5020083449; 5020080991; 5020080693; 5020078943; 5020073346; 5020072388; 5020071964; 5020070809; 5020069750; 5020068363; 5020067161; 5020064890; 5020078443; 5020074299; 5020064414 
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Omaha, NB, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2086-11
CODE
Units: 5020150946; 5020149431; 5020148684 
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Omaha, NB, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2087-11
CODE
Units: 4570139412; 4570138906; 4570138231; 4570137624; 4570135610; 4570134455; 4570133514; 4570132947; 4570132413
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Charlotte, NC, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2088-11
CODE
Units: 4590125897; 4590125179
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Jacksonville, FL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-2097-11
CODE
Unit: W053311604049
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on July 5, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to current Good Manufacturing Practices, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2099-11
CODE
Unit: 53G18699
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by electronic mail on June 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2145-11
CODE
Units: 29KM72106; 29KM72108; 29KM72091; 29KM72092; 29KM72093; 29KM72094; 29KM72097; 29KM72098; 29KM72099; 29KM72101; 29KM72102; 29KM72103; 29KM72104; 29KM72105; 29KM72096; 29KM72107
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by facsimile on July 1, 2011 and letter on July 8, 2011. Firm initiated recall is complete.
REASON
Blood products, in which the hemoglobin QC was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2146-11
CODE
Unit: 011GG75061
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile and letter on July 28, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2148-11
CODE
Unit: LV41398
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by telephone on August 3, 2006 and by letter dated August 3, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the minimum requirement for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2153-11
CODE
Unit: LM60977, LM66239
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on November 10, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at an inappropriate temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B- 2162-11
CODE
Unit: 12GN41187
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter on July 16, 2011.
Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
HLA Fusion Software Version, Product Number: FUSPGR, version 2.0.0-SP1, RSSOH1AC-Update.exe, Product: RSSOH1A. Recall # 2166-11
CODE
RSSOH1A LOT 003, RSSOH1C LOT 001, RSSOH1C LOT 002, RSSOH1A LOT 004, RSSOH1B LOT 005, RSSOH2B1 LOT 004, RSSOH2B1 LOT 005, RSSOH2B1 LOT 006, RSSOH2B1 LOT 04A
RECALLING FIRM/MANUFACTURER
One Lambda, Inc., Canoga Park, CA, by letter on January 17, 2011. Firm initiated recall is ongoing.
REASON
HLA Fusion Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units (14 in US)
DISTRIBUTION
CA, OK, TX, AL, AR, MO, MN, PA, Canada, UK, France, Germany, Netherlands, Sweden/Finland, Spain/Portugal, Middle East, China, Japan
___________________________________
PRODUCT
MEDITECH Blood Bank Software Client Server 6.0 and 6.1. Recall # B-2171-11
CODE
Client Server 6.0 and 6.1
RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mailed task updates on February 11, 2011. Firm initiated recall is complete.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide, Canada, UK
___________________________________
PRODUCT
1) Liquid Plasma. Recall # B-2180-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2181-11;
3) Plasma Frozen. Recall # B-2182-11
CODE
1) Units: S195931, S189391;
2) Unit: S115071;
3) Unit: S140331
RECALLING FIRM/MANUFACTURER
Community Hospital of the Monterey Peninsula, Monterey, CA, by facsimile on October 12, 2005 or November 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis associated with mononucleosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, FL
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system.
Model number 10094012; Model number 7008530. Recall # Z-3009-2011
CODE
Serial numbers: 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432; b) Serial numbers: 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated June 13, 2011. Firm initiated recall is ongoing.
REASON
When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240: Door open/Switching tube/X-ray lock" will appear.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area. Recall # Z-3275-2011
CODE
All-OPMI Pentero
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carl Zeiss Meditec, Inc., Dublin, CA, letter dated September 7, 2011.
Manufacturer: Carl Zeiss, Oberkochen, Germany. Firm Initiated recall is ongoing.
REASON
Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.
VOLUME OF PRODUCT IN COMMERCE
1,677, (741 OPMI Pentero; 739 OPMI Vario and OPMI Neuro 197)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma. Recall # Z-3278-2011
CODE
Units: 71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on August 26, 2011. Firm initiated recall is ongoing.
REASON
The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
VOLUME OF PRODUCT IN COMMERCE
6,269 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use. Part 00-6202-052-21. Recall # Z-3279-2011
CODE
Lot #: 61132698
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated July 27, 2011. Firm initiated recall is ongoing.
REASON
Product may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. There has been one reported incident where the surgeon was unable to lock the liner into the shell because the locking ring groove was too shallow. Investigation revealed that there may be other shells from the same part/lot combination that have the same manufacturing non conformance.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide and Australia, Germany, The Netherlands, and Switzerland
___________________________________
PRODUCT
Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking. Recall # Z-3280-2011
CODE
All 6240-5F and 6240-JR5F wheeled walkers distributed by the firm between 12/15/2010 and 3/4/2011, are subject to recall/correction.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, by letter dated April 7, 2011.
Manufacturer: Hebei HealthPlus Medical Device Co, LTD, Handan City, China. Firm initiated recall is ongoing.
REASON
The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would result in instability of the product and poses the potential for serious injury to the user in the event of a fall.
VOLUME OF PRODUCT IN COMMERCE
12,764 walkers
DISTRIBUTION
Nationwide, PR, Canada, Columbia, and Israel
___________________________________
PRODUCT
ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. Recall # Z-3282-2011
CODE
Units: 00000156053GE1 00000156054GE9 00000160141GE8 00000160142GE6 00000163510GE1 00000177462GE9 00000177463GE7 00000178185GE5 00000181683GE4 00000188460GE0 00000190791GE4 00000193324GE1 00000197286GE8 00000197290GE0 00000199300GE5 00000211314GE0 00000213647GE1 00000224809GE4 00000224810GE2 00000235766GE3 00000154900GE5 00000156057GE2 00000163515GE0 00000174344GE2 00000176430GE7 00000177464GE5 00000183715GE2 00000190793GE0 00000197289GE2 00000202806GE6 00000211312GE4 00000224811GE0 00000230390GE7 00000230391GE5 00000235769GE7 00000239644GE8 00000B10232002 00000R10048002 00000S10145004 00000Z11048001 00000P10256003 00000S10349006 00000Y11012001 000000U9229001 0000AD11124002 0000AH11070001 00000E10344008 000000F9146004 000000F9146006 000000R9210001 000000R9250003 0000AG11102002 0000ZD10349001 00000F10186001 00000R11013001 00000S11004001 00000T11062001 00000U11056001 000000L9299001 000000Q9349002 000000T9285001 00000C11167002 00000P10137001 00000R10117001 00000H10158001 00000K10140002 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00000178184GE8 00000188459GE2 00000197288GE4 00000202807GE4 00000207408GE6 00000207409GE4 00000207410GE2 00000207411GE0 00000207412GE8 00000211313GE2 00000226751GE6 00000227620GE2 00000227623GE6 00000227625GE1 00000230388GE1 00000230392GE3 00000235767GE1 00000235768GE9 00000235771GE3 00000239641GE4 00000239643GE0 00000P10256001 0000AA10243002 00000E10069008 00000X10054002 0000AE11063001 00000T10033004 00000S10165001 0000AD10230002 000000Q9330001 00000U11028003 00000197287GE6 00000213649GE7 00000226748GE2 00000227621GE0 00000230393GE1 00000Y11109001
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, byletters dated August 18, 2011.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France, Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
697
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Boston Scientific, LATITUDE RF Communicator & Software, Model 6482. LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-3283-2011
CODE
MODEL SERIAL 6476 195543 6476 195544 6476 195550 6476 195555 6476 195556 6476 195557 6476 195560 6476 195562 6476 195563 6476 195566 6476 195701 6476 195707 6476 195708 6476 195711 6476 195713 6476 195717 6476 195722 6476 195725 6476 195726 6476 195727 6476 195728 6476 195729 6476 195733 6476 195734 6476 195735 6476 195736 6476 195739 6476 195740 6476 195742 6476 195744 6476 195748 6476 195749 6476 195751 6476 195764 6476 195765 6476 195767 6476 195768 6476 195769 6476 195770 6476 195773 6476 195775 6476 195776 6476 195780 6476 195783 6476 195786 6476 195797 6476 195800 6476 195803 6476 195867 6476 195870 6476 195872 6476 195876 6476 195909 6476 195910 6476 195911 6476 195914 6476 195915 6476 195916 6476 195919 6476 195922 6476 195923 6476 195924 6476 195928 6476 195929 6476 195930 6476 195934 6476 195938 6476 195977 6476 195980 6476 196034 6476 196052 6476 196083 6476 196086 6476 196167 6476 196170 6476 196171 6476 196172 6476 196173 6476 196174 6476 196177 6476 196181 6476 196183 6476 196184 6476 196187 6476 196188 6476 196189 6476 196192 6476 196194 6476 196196 6476 196220 6476 196223 6476 196228 6476 196231 6476 196237 6476 196238 6476 196240 6476 196244 6476 196247 6476 196253 6476 196256 6476 196270 6476 196295 6476 196307 6476 196347 6476 196350 6476 196353 6476 196354 6476 196356 6476 196361 6476 196365 6476 196368 6476 196369 6476 196371 6476 196375 6476 196376 6476 198243 6476 198293 6476 198304 6476 198485 6476 198487 6476 198502 6476 198512 6476 198515 6476 198516 6476 198873 6476 198881 6476 198888 6476 198890 6476 199443 6476 199444 6476 199446 6476 199447 6476 199448 6476 199449 6476 199450 6476 199451 6476 199452 6476 199453 6476 199454 6476 199455 6476 199456 6476 199457 6476 199458 6476 199459 6476 199460 6476 199464 6476 199465 6476 199467 6476 199468 6476 199470 6476 199471 6476 199473 6476 199474 6476 199476 6476 199485 6476 199488 6476 199489 6476 199491 6476 199501 6476 199503 6476 199504 6476 199507 6476 199508 6476 199509 6476 199510 6476 199511 6476 199512 6476 199513 6476 199514 6476 199515 6476 199516 6476 199517 6476 199518 6476 199519 6476 199520 6476 199521 6476 199522 6476 199523 6476 199524 6476 199525 6476 199526 6476 199527 6476 199528 6476 199529 6476 199530 6476 199531 6476 199532 6476 199533 6476 199534 6476 199535 6476 199536 6476 199537 6476 199538 6476 199544 6476 199552 6476 199557 6476 199562 6476 199565 6476 199568 6476 199569 6476 199570 6476 199571 6476 199572 6476 199573 6476 199574 6476 199575 6476 199576 6476 199577 6476 199578 6476 199579 6476 199580 6476 199581 6476 199582 6476 199583 6476 199584 6476 199585 6476 199586 6476 199587 6476 199588 6476 199589 6476 199590 6476 199591 6476 199592 6476 199593 6476 199594 6476 199595 6476 199596 6476 199597 6476 199598 6476 199600 6476 199601 6476 199602 6476 199603 6476 199606 6476 199607 6476 199608 6476 199609 6476 199610 6476 199611 6476 199612 6476 199613 6476 199615 6476 199618 6476 199621 6476 199624 6476 199627 6476 199642 6476 199660 6476 199661 6476 199663 6476 199664 6476 199665 6476 199666 6476 199667 6476 199668 6476 199669 6476 199670 6476 199671 6476 199672 6476 199673 6476 199674 6476 199675 6476 199676 6476 199677 6476 199678 6476 199679 6476 199680 6476 199681 6476 199682 6476 199683 6476 199684 6476 199685 6476 199686 6476 199687 6476 199688 6476 199719 6476 199720 6476 199721 6476 199722 6476 199723 6476 199724 6476 199725 6476 199726 6476 199727 6476 199728 6476 199729 6476 199730 6476 199731 6476 199732 6476 199733 6476 199734 6476 199735 6476 199736 6476 199737 6476 199738 6476 199739 6476 199740 6476 199741 6476 199742 6476 199743 6476 199744 6476 199745 6476 199746 6476 199747 6476 199748 6476 199749 6476 199750 6476 199751 6476 199752 6476 199753 6476 199754 6476 199755 6476 199756 6476 199757 6476 199758 6476 199759 6476 199760 6476 199761 6476 199762 6476 199763 6476 199764 6476 199765 6476 199766 6476 199767 6476 199768 6476 199769 6476 199770 6476 199771 6476 199772 6476 199773 6476 199774 6476 199775 6476 199776 6476 199777 6476 199778 6476 199845 6476 199846 6476 199847 6476 199848 6476 199849 6476 199850 6476 199851 6476 199852 6476 199853 6476 199854 6476 199855 6476 199856 6476 199857 6476 199858 6476 199859 6476 199860 6476 199861 6476 199862 6476 199863 6476 199864 6476 199865 6476 199866 6476 199867 6476 199868 6476 199869 6476 199870 6476 199871 6476 199872 6476 199873 6476 199874 6476 199875 6476 199876 6476 199877 6476 199878 6476 199879 6476 199880 6476 199881 6476 199882 6476 199883 6476 199884 6476 199885 6476 199886 6476 199887 6476 199888 6476 199889 6476 199890 6476 199891 6476 199892 6476 199893 6476 199894 6476 199895 6476 199896 6476 199897 6476 199898 6476 199899 6476 199900 6476 199901 6476 199902 6476 199903 6476 199904 6476 199920 6476 199921 6476 199922 6476 199923 6476 199924 6476 199925 6476 199926 6476 199929 6476 199930 6476 199932 6476 199933 6476 199966 6476 199967 6476 199969 6476 199970 6476 199972 6476 199973 6476 199975 6476 199976 6476 199978 6476 199979 6476 199982 6476 199984 6476 199985 6476 199986 6476 199987 6476 199988 6476 199990 6476 199991 6476 199993 6476 199994 6476 199995 6476 199998 6476 200001 6476 200004 6476 200007 6476 200010 6476 200013 6476 200016 6476 200019 6476 200022 6482 045402 6482 045406 6482 045411 6482 045423 6482 045431 6482 045436 6482 045441
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by letter dated August 2011.
Manufacturers: Benchmark Electronics Inc, Winona, MN;
Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall is ongoing.
REASON
A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message
VOLUME OF PRODUCT IN COMMERCE
470 units
DISTRIBUTION
Nationwide and United Kingdom, France
 
END OF ENFORCEMENT REPORT FOR OCTOBER 5, 2011
 
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