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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 4, 2009

November 4, 2009
09-44

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1)  Dairyshake Powder, Vanilla, Net Wt. 100 grams. The product is packaged in a light brown plastic pouch with dark brown writing. Recall # F-716-9;

2) Dairyshake Powder, Strawberry, Net Wt. 100 grams. The product is packaged in a light brown plastic pouch with dark brown writing. Recall # F-717-9;

3) Dairyshake Powder, Strawberry/Banana, Net Wt. 100 grams. The product is packaged in a light brown plastic pouch with dark brown writing. Recall # F-718-9;

4) Dairyshake Powder, Chocolate, Net Wt 100 grams. The product is packaged in a light brown plastic pouch with dark brown writing. Recall # F-719-9
CODE
1) Lot #'s 7176, 7183, 7190, 7192, 7193, 7194, 7197, 7198, 7199, 7200, 7232, 7234, 7235, 7236, 7239, 7292, 8259, 8288, 8301, 8302, 9131, 9132, & 9133;

2) Lot #'s 7225, 7226, 7227, 7240, 7241, 7275, 7282, 7283, 7284, 7285, 7288, 7289, 7290, 7307, 7309, 7310, 7311, 7312, 7313, 7330, 7331, 7333, 7334, 7344, 7345, 8036, 8037, 8053, 8056, 8057, 8058, 8059, 8060, 8072, 8073, 8074, 8077, 8078, 8079, 8080, 8105, 8106, 8240, 8252, 8253, 8254, 8255, 8259, 8260, 8266, 8267, 8280, 8281, 8282, 8290, 8291, 8294, 8295, 8303, 8304, 8305, 8315, 8352, 8353, 8354, 9005, 9006, 9033, 9034, 9035, 9040, 9041, 9070, 9134, 9135, 9138, & 9139;

3) Lot #'s 8063, 8283, 8284, 8295, 8324, & 8325;

4) Lot #'s 7137, 7137, 7141, 7142, 7143, 7144, 7145, 7179, 7180, 7187, 7201, 7242, 7243, 7247, 7248, 7297, 7296, 7297, 7298, 7299, 7302, 7305, 7307, 7325, 7338, 7299, 7302, 7303, 7304, 7306, 7314, 7323, 7324, 7325, 7337, 7338, 7339, 7340, 7341, 8064, 8066, 8067, 8106, 8107, 8108, 8109, 8116, 8270, 8273, 8274, 8275, 8297, 8298, 8317, & 8318
RECALLING FIRM/MANUFACTURER
Trans-Packers Services Corp., Brooklyn, NY, by letter on June 26, 2009 and press releases on July 7, and July 13, 2009. Firm initiated recall is ongoing.
REASON
Product was manufactured using non-fat dried milk recalled by Plainview Milk products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
UT, IN, TN, OH
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PRODUCT 
STOP & SHOP HomeTown Bakery OLD FASHIONED MOLASSES COOKIES, Net Wt. 8.9 oz (252g), UPC 6 88267 08457 7. Recall # F-1689-9
CODE
SELL BY FEB.22,2010 A (printed on side of package)
RECALLING FIRM/MANUFACTURER
Petri Baking Products Inc., Silver Creek, NY, by telephone on August 30, 2009 and e-mail on August 31, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared peanuts and milk which are known allergens. This poses a health risk to individuals that are allergic to peanuts and/or milk if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
167 cases (2000 packages)
DISTRIBUTION
MA, NH, RI, CT, NY, ME, NJ
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PRODUCT 
1) Kroger Popcorn Seasoning Movie Theater Butter Flavored sold in 2.82-ounce jars under the following UPC code: 0 011110 72445 8. Recall # Recall # F-1690-9;

2) Kroger Fat Free Butter Flavored Sprinkles sold in 2-ounce jars under the following UPC code: 0 011110 66853 0. Recall # Recall # F-1691-9;

3) Kroger Popcorn Seasoning White Cheddar Flavored sold in 2.82-ounce jars under the following UPC code: 0 011110 72444 1. Recall # F-1692-9  
CODE
1) Sell-by date of JUN 08 10;
2) Sell-by dates of JUN 08 10 and JUN 09 10;
3) Sell-by date of JUN 09 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati, OH, by press release and e-mail on June 30, 2009. Firm initiated recall is ongoing.
Manufacturer: Pontiac Foods, Elgin, SC. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,076 bundles/6/2.82 oz packages/case
DISTRIBUTION
Nationwide
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PRODUCT 
Libert Brand 6 oz Mditranne Wild Blackberry Yogurt UPC 0 65684 65434.  Recall # F-1693-9
CODE
SEP02 (Best before or expired date)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Les Produits de Marque Liberte Inc., Saint-Hubert, Canada, by letter dated August 11, 2009 and press release on August 12, 2009.
Manufacturer: Les Produits de Marque Liberte Inc., Brossard, Canada. Firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
2,728 cases
DISTRIBUTION
Nationwide
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PRODUCT 
Red Pepper Ground, 40 SHU - ETO Treated; Product of India 50 pounds; 184577/2584.  Recall # F-1695-9
CODE
Lot number: V15270-05/50
RECALLING FIRM/MANUFACTURER
Van de Vries Spice Corp., East Brunswick, NJ, by telephone and e-mail on August 4, and  letter on August 5, 2009. Firm initiated recall is ongoing.
REASON
The firm received positive test results for Salmonella in Red Ground Pepper imported from India.
VOLUME OF PRODUCT IN COMMERCE
22,850 pounds
DISTRIBUTION
MD, NJ, OR and TX
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PRODUCT 
Van's All Natural Wheat Free Homestyle Pancakes, 12.4 ounce; UPC: 0-89947-60604-9. Recall # F-1696-9
CODE
Lot #200060629B1; Best if Used By Date: March 30, 2010  
RECALLING FIRM/MANUFACTURER
Recalling Firm: Van's International Foods, Vernon CA, by letter dated August 19, 2009.
Manufacturing Firm: Echo Lake Foods, Owensboro, KY. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk, egg, and wheat.
VOLUME OF PRODUCT IN COMMERCE
50 cases (12 units/case)
DISTRIBUTION
NH, CA, WA
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PRODUCT 
Chinese Vermicelli Dressing in 16 oz. plastic deli container labeled "PASTA & CO CHINESE VERMICELLI", 8/case with case labeled "Chinese Vermicelli Dressing". Recall # F-1697-9
CODE
Firm uses Julian dates as batch codes for date of manufacture, no year indicated. No expiration dates or best by dates. Julian Code dates for 2009: 113, 106, 99, 92, 84, 78, 69, 57, 48, 35, 28, 16, 04. Julian Code dates for 2008: 362, 354, 347, 339, 329, 315, 308, 300, 288, 277, 272, 267, 261, 254, 249, 239, 232, 225, 218, 210, 203, 198, 191, 185, 178, 172, 165, 156, 151, 147, 140, 134, 126, 120, 109, 105, 98, 86, 81, 74, 67, 58, 50, 46, 42, 32, 25, 21, 15, 04 
RECALLING FIRM/MANUFACTURER
Cucina Fresca, Inc., Seattle, WA, by telephone and email dated April 24, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using Lien How Chili Oil recalled by Union International Food Co. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,328/16 oz containers
DISTRIBUTION
WA
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PRODUCT 
1) Chinese Vermicelli Salad. Product is sold through cafe display case counter and have a food card identifying the name of the product. No UPC codes, or labeling other than a "pasta & co delibakerypantry" sticker on take away container. Product may be packaged in paper carton 16, 26, or 32 oz box for take away. First three ingredients for product: vermicelli pasta (durum semolina flour, egg, water), sesame seeds, Chinese vermicelli dressing (sesame oil, soy sauce (wheat, soybeans, salt), vinegar, chili oil (soybean oil, chili), sugar). Recall # F-1698-9;  

2) Pot Sticker Salad. Product is sold through cafe display case counter and have a food card identifying the name of the product. No UPC codes or labeling other than a "pasta & co delibakerypantry" sticker on take away container. Product may be packaged in paper carton 16, 26, or 32 oz box for take away. Ingredients include: vegetable ravioli (durum semolina flour, egg, zucchini, potato, yellow squash, olive oil, yellow onion, red peppers, garlic, ginger, balsamic vinegar, canola oil, salt, oregano, basil, thyme, marjoram, black pepper), carrots, celery, red bell pepper, broccoli, Chinese vermicelli dressing (sesame oil, soy sauce (wheat, soybeans, salt), vinegar, chili oil (soybean oil, chili), sugar), green onions. Recall # F-1699-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Sugar Mountain Capital, LLC dba Pasta & Co., Seattle, WA, by email on April 24, 2009 and press release on April 29, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using chili oil recalled by Union International Food Co. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Chinese Vermicelli: 7,291.01 lbs; and Pot Sticker Salad: 171.26 lbs
DISTRIBUTION
WA
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PRODUCT 
1) Asian Noodle (pasta salad with dressing). Product is packaged in 8 oz (6/case) round plastic containers and 5lb. (2/case) round plastic tubs. Catalog number 101008/6 for 8 oz., and 101008 for 5 lb. container. Case Label includes "Asian Noodle Keep Refrigerated" as well as "use by date:” Ingredient list, and package amount/size (6/8oz or 2/5lb). First three ingredients include: Pasta (durham wheat semolina, ferrous sulfate, niacin, thiamin mononitrate, riboflavin, folic acid. May contain a trace of egg), Peppers, Green Onion. Container labels: 8 oz. container is sold in retail grocery stores. Label includes "Asian Noodle Keep Refrigerated Net WT. 8oz (227g)", Use by: date, Ingredient list, Nutrition Facts, and UPC code 6 30271 10108 5. 5 lb. container is sold for Food Service only. Label includes "Asian Noodle Keep Refrigerated" as well as a "Use By:" date. Recall # F-1716-9;

2) Thai Peanut Salad (pasta salad with peanut dressing). Product is packaged in 5lb. (2/case) round plastic tubs. Catalog number 104080. Case Label includes "Thai Peanut Salad 2 / 5lb Keep Refrigerated" as well as "use by date:", and Ingredient list. First three ingredients include: Pasta (durham wheat semolina, ferrous sulfate, niacin, thiamin mononitrate, riboflavin, folic acid. May contain a trace of egg), Tofu (water, soybeans, bittern or nigari, calcium sulfate), Carrots. Container label: 5 lb. container is sold for Food Service only. Label includes "Thai Peanut Salad Keep Refrigerated" as well as a "Use By:" date. Recall # F-1717-9;

3) Picnic Spicy Noodle w Peanuts (pasta salad with sauce and nuts). Product is packaged in 9 oz (6/case) round plastic containers and 5lb. (2/case) round plastic tubs. Catalog number 144009/6 for 9 oz, and 144009 for 5lb container. Case Label includes "Picnic Spicy Noodle w Peanuts Keep Refrigerated" as well as "use by date:", Ingredient list, and package amount/size (6/9oz or 2/5lb). First three ingredients include: Pasta (durham wheat semolina, ferrous sulfate, niacin, thiamin mononitrate, riboflavin, folic acid. May contain a trace of egg), Peanuts, Carrots. Container labels: 9 oz. container is sold in retail grocery stores. Label includes "Picnic Spicy Noodle w Peanuts Keep Refrigerated Net WT. 9oz (255g)", Use by: date, Ingredient list, Nutrition Facts, and UPC code 6 30271 14409 9. 5 lb. container is sold for Food Service only. Label includes "Picnic Spicy Noodle w Peanuts Keep Refrigerated" as well as a "Use By:" date. Recall # F-1718-9;

4) Spicy Yakisoba Noodles (pasta with sauce). Product is packaged in 5lb. (2/case) round plastic tubs. Catalog number 275080. Case Label includes "Spicy Yakisoba Noodles 2 / 5lb Keep Refrigerated" as well as "use by date:", and Ingredient list. First three ingredients include: Noodles (wheat flour, water, egg, salt, baking soda and corn starch), Carrots, Worcestershire Sauce. Container label: 5 lb. container is sold for Food Service only. Label includes "Spicy Yakisoba Noodle Keep Refrigerated" as well as a "Use By:" date. Recall # F-1719-9;

5) Asian Broccoli & Edamame Crunch (vegetables with sauce). Product is packaged in 5lb. (2/case) round plastic tubs. Catalog number 345080. Case Label includes "Asian Broccoli & Edamame Crunch Real Foods Seattle, WA 98108 2 / 5lb Keep Refrigerated" as well as "use by date:", and Ingredient list. First three ingredients include: Broccoli, Carrots, Rice Vinegar (rice vinegar, water). Container label: 5 lb. container is sold for Food Service only. Label includes "Asian Broccoli & Edamame Crunch Keep Refrigerated" as well as a "Use By:" date. Recall # F-1720-9;

6) Peanut Sauce (Peanut butter with fruit and coconut). Product is packaged in 12 oz (6/case) round plastic containers and 1 gal. plastic jug. Catalog number 737012/6A for 12 oz, and 737128 for 1 gallon container. Case Label includes "Peanut Sauce, Keep Refrigerated" as well as "use by date:", Ingredient list, and package amount/size (6/12oz or 1 gal). First three ingredients include: Peanut Butter (peanuts, sugar, hydrogenated vegetable oils (canola, cottonseed, soybean, salt), Pineapple (pineapple and pineapple juice), Soy Sauce (water, wheat, soybeans, salt, sodium benzoate). Container labels: 12 oz. container is sold in retail grocery stores. Label includes "Real Foods Peanut Sauce Net Wt. 12 oz (340g) Keep Refrigerated", Use by: date, Ingredient list, Nutrition Facts, and UPC code 6 30271 73713 0. 1 gallon container is sold for Food Service only. Label includes "real Foods Peanut Sauce 1 Gal (3.79L) Keep Refrigerated" as well as ingredient statement, and "Use By:" date. Recall # F-1721-9;

7) Asian Noodle Salad - LL (pasta with Asian vinagrette). Product is packaged in 5lb. (2/case) round plastic tubs. Catalog number 9310080. Case Label includes "Asian Noodle Salad - 2/5lb Keep Refrigerated" as well as "use by date:", and Ingredient list. First three ingredients include: Pasta (durham wheat semolina, iron (ferrous sulfate), thiamin mononitrate (vitamin B1), riboflavin (vitamin B2), folic acid), Soy Sauce (water, soy beans, salt, sugar & wheat flour), Sesame Oil. Container label: 5 lb. container is sold for Food Service only. Label includes "Asian Noodle Salad - L Keep Refrigerated" as well as a "Use By:" date. Recall # F-1722-9
CODE
1), 2), 3), 4), 5), 7) Use by dates include March-1-2009 through May-12-2009;
6) Use by dates include March-1-2009 through June-5-2009
RECALLING FIRM/MANUFACTURER
Real Foods, Seattle, WA, by email and telephone on April 23, 2009 and April 24, 2009 and by press release on May 1, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using chili oil recalled by Union International Food Co. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
486/ 8oz; 180/ 9oz; 18/ 12oz; 1,045/ 5lb; 22/ 1gal containers
DISTRIBUTION
WA, OR
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PRODUCT 
1) TexJoy Red Pepper (Cayenne), Net Wt. 3 oz. 85 g and Net Wt 8 oz. 225 g; UPC 7821600413 for 8 oz; UPC 7821600621 for 3 oz. Recall # F-1723-9;

2) Bad Byron's Butt Rub Barbeque Seasoning, Net Wt. 4.5 oz (128g), UPC 4492312067. Recall # F-1724-9;

3) Leo's Italian Spice Mix, 17.5 lbs. net wt., UPC 78216 20596. Recall # F-1725-9
CODE
Lots: A29A07A2012, A28A07A2012, and A30A07A2012
RECALLING FIRM/MANUFACTURER
Texas Coffee Co, Inc., Beaumont, TX, by telephone and press release on August 31, 2009. Firm initiated recall is ongoing.
REASON
Product has the potential to contain salmonella.
VOLUME OF PRODUCT IN COMMERCE
630 pounds Italian mix; 3,240 units rub; and 1,596 units red pepper
DISTRIBUTION
TX, LA
___________________________________
PRODUCT 
1) Explosive Espresso Chip Cookie dated 01/15/09 through 02/05/09. The product was distributed in packages of 5/4.25 oz. individually wrapped cookies. UPC is 703741 001014. Recall # F-1726-9;

2) Colossal Chocolate Chip Cookie dated 01/15/09 through 02/05/09. The product was distributed in packages of 5/4.25 oz. individually wrapped cookies. UPC is 703741 000178. Recall # F-1727-9;

3) Peanut Butter Chocolate Chip Cookie dated 01/15/09 through 02/05/09. The product was distributed in packages of 5/4.25 oz. individually wrapped cookies. UPC is 703741 000635. Recall # F-1728-9;

4) Double Chocolate Decadence Cookie dated 01/15/09 through 02/05/09. The product was distributed in packages of 5/4.25 oz. individually wrapped cookies. UPC is 703741 000628. Recall # F-1729-9;

5) Mac the Chip Cookie dated 01/15/09 through 02/05/09. The product was distributed in packages of 5/4.25 oz. individually wrapped cookies. UPC is 703741 000352. Recall # F-1730-9
CODE
"015" through "036" stamped on fold of cellophane package
RECALLING FIRM/MANUFACTURER
Alternative Baking Company Inc., Sacramento, CA, by letter dated March 10, 2009. Firm initiated recall is ongoing.
REASON
Chocolate Chips in cookies contain undeclared milk.

VOLUME OF PRODUCT IN COMMERCE
103,618 cookies
DISTRIBUTION
Nationwide, including Alaska and Hawaii

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

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PRODUCT 
Apple Cider McIntosh Blend 1/2 Gallon plastic jug. Recall # F-1606-9
CODE
Exp Date 08/06/09  
RECALLING FIRM/MANUFACTURER
Ricker Hill Orchards, Turner, ME, by telephone on June 11, 2009. Firm initiated recall is complete.
REASON
A sample of apple cider collected by the Connecticut Department of Consumer Protection tested positive for Fenhexamid at 0.030 ppm.
VOLUME OF PRODUCT IN COMMERCE
24 cases 9 1/2 gallon jugs per case
DISTRIBUTION
ME, NH, MA, CT, RI
___________________________________
PRODUCT 
Libert 6 oz Mditranne Plum Walnut Yogourt UPC 0 65684 65431 4. Recall # F-1694-9
CODE
SEP02 (Best before or expired date)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Les Produits de Marque Liberte Inc., Saint-Hubert, Canada, by letter dated August 11, 2009 and press release on August 12, 2009.
Manufacturer: Les Produits de Marque Liberte Inc., Brossard, Canada. Firm initiated recall is ongoing.
REASON
The product labeled as Plum & Walnut Yogourt actually contains a different product, Wild Blackberry Yogourt.
VOLUME OF PRODUCT IN COMMERCE
2,728 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Ricos Condensed Aged Cheddar Cheese Sauce; net wt. a) 15 oz. cans (#303 can), UPC 0 79426 21112 3, 12 cans per case, and net wt. b) 6 lb. 11 oz. cans (#10 can), UPC 0 79426 76000 3, 6 cans per case; 15 oz. can - UPC 0 79426 21112 3, 6 lb. 11 oz. can - UPC 0 79426 76000 3. Recall # F-1655;

2)  Casa Solana Sharp Aged Cheddar Cheese Sauce, Ready to Serve, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 74865 29224 5. Recall # F-1656-9; 

3) Operators' Choice Sharp Aged Cheddar Cheese Sauce, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 27000 24115. Recall # F-1657-9; 

4) Mi Pueblo Aged Cheddar Cheese Sauce, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 51974 17092 3. Recall # F-1658-9;

5) Cheddar Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; packaged under the following labels: a) Checkers/Rally's Ready to Serve Sharp Aged Cheddar Cheese Sauce, UPC 0 41195 07663 0; b) Classic Foods Cheddar Cheese Sauce, UPC 7 57928 00530 2 . Recall # F-1659-9;

6) Ready to Serve Creamy Cheddar Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; packaged under the following labels: a) Bay Valley Foods Select Ready to Serve Creamy Aged Cheddar cheese Sauce; UPC 0 41820 05582 5; b) Sysco Reliance Ready to Serve Mild Creamy Cheddar Cheese Sauce; UPC 0 74865 26353 9. Recall # F-1660-9;

7) Bay Valley Foods Select Ready to Serve Cheddar Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 41820 04393 8 . Recall # F-1661-9;

8)  Cheddar Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; packaged under the following labels: a) Club Select Special Blend Cheddar Cheese Sauce; UPC 0 40000 03521 3; b) Menu Solutions Nacho Cheese Sauce, UPC 7 500093 231341. Recall # F-1662-9;

9) Bay Valley Foods Select Ready to Serve Nacho Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 41820 04397 6. Recall # Recall # F-1663-9;

10) Sysco Reliance Ready to Serve Nacho Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 74865 12230 6. Recall # F-1664-9;

11) Harvest Value Nacho Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 7 58108 01968 3. Recall # F-1665-9;

12) El Pasado Nacho Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 7 58108 02176 1. Recall # F-1666-9;

13) Casa Solana Nacho Cheese Sauce, Ready to Serve, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 74865 29227 6. Recall # F-1667-9; 

14) Mi Pueblo Nacho Cheese Sauce, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 51974 17091 6. Recall # F-1668-9; 

15) Ricos Gourmet Nacho Cheddar Cheese Sauce; net wt. 15 oz. cans (#303 can), 12 cans per case; UPC 0 79426 21110 9. Recall # F-1669-9;

16) Casa Solana Jalapeno Cheese Sauce, Ready to Use, Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 74865 29225 2. Recall # F-1670-9;

17) Sysco Reliance Ready to Serve Jalapeno Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 74865 12229 0. Recall # F-1671-9;

18) Bay Valley Foods Premium Ready to Serve Jalapeno Cheese Sauce; Net Wt. 6 lb. 11 oz. (3.03 kg); 6 #10 cans/case; UPC 0 41820 04398 3. Recall # F-1672-9;

19) Bay Valley Foods Premium Milk First Ready to Serve Chocolate Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; UPC 0 41820 04400 3. Recall # F-1673-9; 

20) Sysco Classic Ready to Serve Chocolate Pudding; Net 3.18 kg/7 lb, 6 #10 cans/case; Product of U.S.A.; UPC 0 74865 46354 6. Recall # F-1674-9;

21) Ready to Serve Chocolate Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; sold under the following labels: a) Monarch Chocolate Pudding; UPC 7 58108 09118 4; b) Sysco Classic Ready to Use Chocolate Pudding; UPC 0 74865 10381 7; c) Thank You The Ultimate Chocolate Pudding; UPC 0 41820 06219 9; d) Signature Chocolate Pudding; UPC 0 41493 27236 9. Recall # F-1675-9

22) Ready to Serve Milk Chocolate Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; sold under the following labels: a) Sysco Classic Ready to Use Milk Chocolate Pudding; UPC 0 74865 10549 1; b) Thank You The Ultimate Milk Chocolate Pudding; UPC 0 41820 06220 5; c) UniPro Foodservice Marquis Milk Chocolate Pudding; UPC 0 44105 67553 4. Recall # F-1676-9;

23) Bay Valley Foods Premium Milk First Ready to Serve Vanilla Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; UPC 0 41820 04401 0. Recall # F-1677-9;

24) Sysco Classic Ready to Serve Vanilla Pudding Artificially Flavored Vanilla; Net 3.18 kg/7 lb, 6 #10 cans/case; Product of U.S.A.; UPC 0 74865 46355 3. Recall # F-1678-9

25) Ready to Serve Vanilla Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; sold under the following labels: a) Monarch Vanilla Pudding; UPC 7 58108 09122 1; b) Sysco Classic Ready to Use Vanilla Pudding; UPC 0 74865 10384 8; c) Thank You The Ultimate Vanilla Pudding; UPC 0 41820 06221 2; d) Pocahontas Vanilla Pudding; UPC 0 41560 14108 6 e) UniPro Foodservice Marquis Vanilla Pudding; UPC 0 44105 67557 2. Recall # F-1679-9;

26) Bay Valley Foods Premium Milk First Ready to Serve Butterscotch Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; UPC 0 41820 04402 7. Recall # F-1680-9;

27) Sysco Classic Ready to Serve Butterscotch Pudding Artificially Flavoured; Net 3.18 kg/7 lb, 6 #10 cans/case; Product of U.S.A; UPC 0 74865 46356 0. Recall # F-1681-9;

28) Ready to Serve Butterscotch Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; sold under the following labels: a) Monarch Butterscotch Pudding; UPC 7 58108 09117 7; b) Sysco Classic Ready to Use Butterscotch Pudding; UPC 0 74865 10380 0; c) Thank You The Ultimate Butterscotch Pudding; UPC 0 41820 06223 6; d) UniPro Foodservice Marquis Butterscotch Pudding; UPC 0 44105 67551 0. Recall # F-1682-9;

29) GFS Rice Pudding; Net Wt. 112 oz. (7 lb.) 3.18 kg, 6 #10 cans/case; UPC 0 93901 18028 5. Recall # F-1683-9;

30) Sysco Classic Ready to Serve Rice Pudding; Net 3.18 kg/7 lb, 6 #10 cans/case; Product of U.S.A.; UPC 0 74865 46358 4. Recall # F-1684-9;

31) Ready to Use Rice Pudding; Net Wt. 7 lb. (3.18 kg), 6 #10 cans/case; sold under the following labels: a) Monarch Rice Pudding; UPC 7 58108 09120 7; b) Sysco Classic Ready to Use Rice Pudding; UPC 0 74865 10518 7. Recall # F-1685-9;

32) GFS Tapioca Pudding; Net Wt. 108 oz. (6 lb. 12 oz.) 3.06 kg, 6 #10 cans/case; UPC 0 93901 18029 2. Recall # F-1686-9;

33) Ready to Serve Tapioca Pudding; Net Wt. 6 lb. 12 oz. (3.06 kg), 6 #10 cans/case; sold under the following labels: a) Monarch Tapioca Pudding; UPC 7 58108 09121 4; b) Sysco Classic Ready to Use Tapioca Pudding; UPC 0 74865 10386 2; c) Thank You The Ultimate Tapioca Pudding; UPC 0 41820 04405 8; d) UniPro Foodservice Marquis Tapioca Pudding; UPC 0 44105 67556 5. Recall # F-1687-9
CODE
1) a) Lot number 08007019, use by 12/30/2010; b) lot 08806239, use by 12/22/2010; lot 08806269, use by 12/25/2010; lot 08807029, use by 12/31/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

2) Lot number 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

3) Lot 08806179, use by 9/16/2010 Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

4) Lot 08807099, use by 10/8/2010 Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

5) Checkers label: Lot 08106279, use by 9/26/2010; lot 08806179, use by 9/16/2010; lot 08807099, use by 10/8/2010. Classic Foods label: lot number 08806179, use by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

6) Lot number 08806179, best by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

7) Lot number 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

8) a) Lot 08106279, use by 12/26/2010; b) lot 08106189, use by 12/17/2010 and lot 08106279, use by 12/26/2010;
 
9) Lot 08806179, use by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

10) Lot 08107039, use by 10/2/2010 and lot 08806179, use by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

11) Lot 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

12) Lot 08107039, use by 10/2/2010;  

13)  Lot 08806179, use by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

14) Lot 08107039, use by 10/2/2010 and lot 08806179, use by 9/16/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

15) Lot 08006189, use by 12/17/2010, lot 08006259, use by 12/24/2010 and lot 08007089, use by 1/6/2011;

16) Lot 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

17) Lot 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

18) Lot 08807099, use by 10/8/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

19) Lot 08806159, use by 9/14/2010 and lot 08806309, use by 9/29/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

20) Lot 08806159, use by 9/14/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

21) a) Lot 08106159, use by 6/16/2010; lot 08806159, use by 6/16/2010; lot 08806239, use by 6/24/2010; lot 08806309, use by 7/1/2010; Sysco, b) lot 08806159, use by 9/14/2010 and lot 08806309, use by 9/29/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

22) Lot 08806159, use by 9/14/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

23) Lot 08806299, use by 6/30/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

24) Lot 08806229, use by 6/23/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

25) Lot 08806239, use by 6/24/2010 and lot 08806299, use by 6/30/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall.

26) Lot 08806229, use by 6/23/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall.

27) Lot 08806229, use by 6/23/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

28) Lot 08107139, use by 7/14/2010 and lot 08806229, use by 6/23/2010; Please note: For lots beginning with "088", only cans with an "A" between the lot and military time are affected, i.e. "088061597311B A 21:36" is subject to the recall while "088061597311B H 21:36" is not subject to the recall. Also those lots beginning with "088" that have a case code ending in L1 are affected by the recall, but those lots beginning with "088" that have a case code ending in L3 are not affected by the recall;

29) Lot 08106169, use by 6/17/2010;

30) Lot 08106169, use by 6/17/2010;

31) Lot 08106249, use by 6/25/2010;

32) Lot 08106169, use by 6/17/2010 and lot 08107079, use by 7/8/2010;

33) a) Lot 08106249, use by 6/25/2010, lot 08106279, use by 6/28/2010 and lot 08107079, use by 7/8/2010; b) Lot 08106169, use by 6/17/2010, lot 08106249, use by 6/25/2010 and lot 08107079, use by 7/8/2010; c) Lot 08106169, use by 6/17/2010 and lot 08107079, use by 7/8/2010; d) Lot 08106249, use by 6/25/2010 and lot 08107079, use by 7/8/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bay Valley Foods, Westchester, IL, by letters on July 10, 2009, July 30, 2009, August 24, 2009, and September 1, 2009.
Manufacturer: Bay Valley Foods LLC, Dixon, IL. Firm initiated recall is ongoing. 
REASON
Some of the cheese sauce and puddings have experienced flat sour spoilage.
VOLUME OF PRODUCT IN COMMERCE
#303 can - 12,232 cases, #10 can - 58,150 cases
DISTRIBUTION
Nationwide, Canada, Mexico

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Pure & Klean Hand Sanitizer (Isopropyl Alcohol 65%), packaged in 10 fl. oz. (296 ml) bottles, Kills 99.99% of Germs, Moisturizes with Vitamin E, also labeled as: Klean Hands Hand Sanitizer and Guaynabo City Hand Sanitizer. Recall # D-025-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Universal Manufacturing Corp., Vega Alta, PR, by letter, on September 29, 2009. Firm initiated recall is ongoing.
REASON
GMP Deviations
VOLUME OF PRODUCT IN COMMERCE
24,595 bottles
DISTRIBUTION
PR
___________________________________
PRODUCT 
1)  Clonazepam Tablets, USP, 0.5 mg in 100 count bottles (NDC 0093-0832-01 - shipped 120 bottles per case) and 500 count bottles (NDC 0093-0832-05 - shipped 72 bottles per case), Rx Only. Recall # D-026-2010;

2) Clonazepam Tablets 1.0 mg in 100 count bottles (NDC 0093-0833-01 - shipped 144 bottles per case), 500 count bottles (NDC 0093-0833-05 - shipped 48 bottles per case) and 1000 count bottles (NDC 0093-0833-10 - shipped 36 bottles per case), Rx Only. Recall # D-027-2010
CODE
1) Lot numbers: 35200435A exp 9/2010, 35200408A exp 9/2010, 35200409A exp 9/2010, 35200436A exp 9/2010, 35200437A exp 9/2010, 35200460A exp 9/2010, 35200462A exp 9/2010, and 35200438A exp 9/2010;

2) Lot numbers: 35200199A exp 2/2010, 35200200A exp 2/2010, 35200201A exp 2/2010, 35200218A exp 2/2010, 35200219A exp 2/2010, 35200278A exp 2/2010, 35200202A exp 2/2010, 35200248A exp 2/2010, 35200220A exp 2/2010 and 35200203A exp 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on August 25, 2009 and August 31, 2009.
Manufacturer: Novopharm Ltd., Scarborough, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Tablets may exceed specifications for weight, thickness and potency.
VOLUME OF PRODUCT IN COMMERCE
870,531 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 mg Single Use Vial, For IV Use only, Sterile lyophilized Suspension, Rx Only, NDC 68817-134-50 --- Australian label: Abraxane 100 mg Nanoparticle albumin-bound paclitaxel powder for injection (suspension) For Intravenous Use Only, PRESCRIPTION ONLY MEDICINE --- Each vial contains: paclitaxel 100 mg, Human Albumin 900 mg --- Abraxis BioScience LLC Distributed in Australia. Recall # D-028-2010
CODE
Lots 406580 (exp. 6/30/2010), 407545 (exp. 6/30/2010), 406427 (exp 9/30/2010), 406453 (exp. (9/30/2010), 406617 (exp. 10/31/2010), 407150 (exp. 2/28/2011). Product Code 103450 and AU103450 (Australia)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Bioscience LLC dba Abraxis Oncology, Los Angeles, CA, by letters dated September 4, 2009.
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
13,455 units (commercial) and 4,732 units (clinical use)
DISTRIBUTION
Nationwide, PR and Australia

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Cryoprecipitated AHF. Recall # Recall # B-0014-10
CODE
Unit: 9862515
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax On March 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0015-10
CODE
Units: 7373689, 7367377, 7343194, 7333394
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Melbourne, FL, by telephone and letter on June 18, 2009, July 29, 2009 and August 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0016-10;
2) Platelets Leukocytes Reduced. Recall # B-0017-10
CODE
1) and 2) Unit: 42L48974
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by fax on June 22, 2009 and July 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported living in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0018-10;
2) Cryoprecipitated AHF. Recall # B-0019-10
CODE
1) and 2) Unit: 004J14656
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on June 18, 2009 and by e-mail and follow-up letter on June 24, 2009. 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
MA, ME
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0022-10;  
2) Red Blood Cells. Recall # B-0023-10;  
3) Plasma Frozen Within 24 Hours After Phlebotomy (FP24).  Recall # B-0024-10
CODE
1) Unit: 004LF27246;
2) and 3) Unit: 004Z53797
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on June 18, 2009 and by follow-up letter dated June 19, 2009. 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
NY, MA
___________________________________
PRODUCT 
Source Plasma. Recall # B-0025-10
CODE
Unit: 08FOHJ7754
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P, Findlay, OH, by fax on July 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma. Recall # B-0026-10
CODE
Recall # 08BMTF3762
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P, Billings, MT, by fax on July 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0032-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0033-10
CODE
1) and 2) Unit: 012FG24781
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter dated February 20, 2009.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC, NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0035-10

CODE
Unit: 22FS76038
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and e-mail on June 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
1) Plasma Frozen Within 24 hours After Phlebotomy (FP24). Recall # B-0038-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0039-10
CODE
1) and 2) Unit: 22KH39833
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone and fax on April 29, 2009. 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
NJ, PA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0040-10;
2) Plasma Frozen Within 24 hours After Phlebotomy (FP24). Recall # B-0041-10 
CODE
1) and 2) Unit: 004FR40511
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone on June 4, 2009 and fax on June 16, 2009. 
Manufacturer: American Red Cross Blood Services NE Region, Portland, ME. 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, CT
___________________________________
PRODUCT 
Source Plasma, Recall # B-0049-10
CODE
Units: AU0058868, AU0059433, AU0060491, AU0058011
RECALLING FIRM/MANUFACTURER
DCI Biologicals Austin, LLC, Austin, TX, by fax on June 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding having received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0050-10
CODE
Unit: W090709005628
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by telephone and fax on May 29, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0051-10
CODE
Unit: 032FT19944
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone and e-mail on May 14, 2009 and by letter on May 14, 2009 and June 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-0055-10
CODE
Units: 1379867, 1242501
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by e-mail on July 14, 2009 and by letter on July 28, 2009. 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
MN
___________________________________
PRODUCT 
Source Plasma. Recall # B-0056-10
CODE
Unit: 08FING7057
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by fax on June 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0058-10
CODE
Units: 6287648 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 13, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0059-10;
2) Fresh Frozen Plasma. Recall # B-0060-10
CODE
1) and 2) Unit: 2445685
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for the variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets. Recall # B-0062-10
CODE
Units: FF52897; FF53017; GM69029; GM69027; GM69024; GM69020; GM69019; GM69018;  GM70380; GM70376; GM70377
RECALLING FIRM/MANUFACTURER
Washington Hospital Center Building Bk, Washington, DC, by letter dated December 11, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not prepared in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
DC, MD
___________________________________
PRODUCT 
Source Plasma. Recall # B-0070-10
CODE
Units: 365107805; 365107036; 365105148; 365102546; 365102351; 365101734; 365101634; 365086097; 365086072
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by fax on July 28, 2008.
Manufacturer: Telecris Plasma Resources, Roanoke, VA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was indefinitely deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-0071-10
CODE
Unit: 4252491
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on March 4, 2005. 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
FL
___________________________________
PRODUCT 
Platelets. Recall # B-0073-10
CODE
Units: 9218043; 9218048; 9218050; 9217894
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on August 20, 2007 and by fax on September 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0075-10
CODE
Units: 18GN51993 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on August 14, 2006 and by follow-up letter on August 28, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced. Recall # B-0079-10
CODE
Unit: 13FC69921
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on May 2, 2006 and by follow-up letter on May 26, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced. Recall # B-0080-10
CODE
Unit: 18GM34303
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 6, 2008 and follow-up letter on November 17, 2008. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Source Plasma. Recall # B-0115-10 
CODE
Units: GA1144231; GA1144705; GA1145453; GA1146020; GA1146672; GA1147282; GA1147890; GA1148377; GA1149114; GA1149756; GA1150447; GA1150976; GA1152179; GA1155886; GA1156325; GA1157119; GA1157638; GA1158431; GA1158754; GA1159350; GA1159876; GA1160500; GA1161083; GA1161821; GA1163218; GA1164052; GA1164395; GA1167461; GA1168030; GA1169073; GA1169630; GA1176451; GA1177480; GA1177952; GA1178951; GA1179287; GA1180066
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by electronic mail on February 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
NY, UK, Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0020-10
CODE
Unit: 004J14656
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on June 18, 2009 and by e-mail and follow-up letter on June 24, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0021-10
CODE
Unit: 004LF27246
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on June 18, 2009 and by follow-up letter dated June 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma, Recall # B-0027-10
CODE
Unit: 08MOHF7064
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH, by fax on July 17, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0034-10
CODE
Unit: 22FS76038
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and e-mail on June 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Fresh Frozen Plasma (Apheresis), Recall # B-0036-10; 
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0037-10
CODE
1) Unit: 3728412;
2) Units: 3728412, 3722785
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on June 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using expired apheresis collection kits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0052-10
CODE
Unit: 032FT19944
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone and e-mail on May 14, 2009 and by letter on May 14, 2009 and June 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-0053-10
CODE
Unit: 6120132155
RECALLING FIRM/MANUFACTURER
CSI Plasma, Inc., Columbia, SC, by fax on June 10, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0054-10
CODE
Units: 1379867, 1242501
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by e-mail on July 14, 2009 and by letter on July 28, 2009. 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
Switzerland
___________________________________
PRODUCT 
Source Plasma. Recall # B-0074-10
CODE
Unit: 365074882
RECALLING FIRM/MANUFACTURER
Telecris Plasma Resources, Roanoke, VA, by fax on June 4, 2008. 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
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red blood cells, leukocytes reduced. Recall # B-0081-10
CODE
Units: 13GF06670, 13GF06671, 13GF06672, 13GF06673, 13GF06674, 13GF06675, 13GF06676, 13GF06677, 13GF06678, 13GF06679, 13GF06681, 13GF06684, 13GF06685, 13GF06686, 13GF06687, 13GF06688, 13GF06689, 13GF06690, 13GF06691, 13GF06692, 13GF06693, 13GF06694, 13GF06695, 13GF06696, 13GF06697, 13GF06698, 13GF06699, 13GF06700, 13GF06701, 13GF06703 and 13GF06704
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on September 1, 2006 and by follow-up letters dated between September 19, 2006 and November 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales for which the daily quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
MI, NB, PR

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy. Recall # Z-2030-2009
CODE
Serial Numbers: 37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211, 37038365, 37135986, 37154526 and 37154638
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by telephone beginning August 18, 2009and letter dated August 2009. Firm initiated recall is ongoing.
REASON
The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System (SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
DC, MN, and Japan
__________________________________
PRODUCT 
Pedi-Cap CO2 Detector, 1 kg - 15 kg, Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement. Recall # Z-2047-2009
CODE
Lot Numbers: 8294199, 8301112, 8301113, 8315189, 8315190, 8319262, 8319263, 8322181, 8322182, 8326251, 8326252, 8326253, 8326254, 8329072, 8329073, 8330001, 8333183, 8350018, 8350019, 8354221, 8354224, 8357021, 8357022, 8361153, 9005011, 9005012, 9012058, 9012059, 9026042, 9026043, 9033128, 9033129, 9040067, 9040068, 9047127, 9047128, 9054110, 9054111, 9061066, 9061067, 9065209, 9068061, 9068062, 9072281, 9075059, 9075060, 9079160, 9082376, 9082377, 9086312, 9089126, 9089127, 9103038, 9103039, 9110481, 9110482, 9117039, 9117040, 9124134, 9124135, 9131188, 9131189, 9138084, 9138085, 9138226, 9145088, 9145089, 9152238, 9152239, 9159128, 9159129, 9170191, 9170192, 9170197, 9176471, 9176477, 9184145, 9191233, 9191234 and 9204128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien Limited, Boulder, CO, by letter dated August 14, 2009.
Manufacturer: Nellcor Puritan Bennett Mexico, S.A. de C.V., Tijuana B.C., Mexico. Firm initiated recall is ongoing.
REASON
CO2 detector may increase resistance to air flow in an intubated patient.
VOLUME OF PRODUCT IN COMMERCE
238,380 units (US), 38,010 units (Foreign)
DISTRIBUTION
FL, ID, MD, NC, VA, PA, PR, Australia, Belgium, Canada, Japan, Singapore
___________________________________
PRODUCT 
Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Recall # Z-2049-2009
CODE
Lot Number: F15174
RECALLING FIRM/MANUFACTURER
Penumbra, Inc., Alameda, CA, by telephone and e-mail on May 29, 2009. Firm initiated recall is ongoing.
REASON
Leakage – Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IA, NJ, NY, VA, and Canada
___________________________________
PRODUCT
1) Protex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm, Product Code: 100/105/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2056-2009;

2) Protex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code: 100/105/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2057-2009;

3) Protex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.5 mm, Product Code: 100/105/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2058-2009;

4) Protex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Product Code: 100/111/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2059-2009;

5) Protex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code: 100/111/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2060-2009;

6) Protex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm Product Code: 100/111/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2061-2009;

7) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2062-2009;

8) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.0 mm Product Code: 100/126/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2063-2009;

9) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.5 mm Product Code: 100/126/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2064-2009;

10) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2065-2009;

11) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm Product Code: 100/141/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2066-2009;

12) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2067-2009;
13) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 2.5 mm Product Code: 100/127/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2068-2009;

14) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code: 100/127/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2069-2009;

15) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm Product Code: 100/127/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2070-2009;

16) Protex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2071-2009;

17) Protex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2072-2009  
CODE
Product manufactured before September 2009 and within its expiration date.
RECALLING FIRM/MANUFACTURER
Smiths Medical, Hythe Kent, United Kingdom, by letter dated August 24, 2009 and September 9, 2009. Firm initiated recall is ongoing.
REASON
Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
VOLUME OF PRODUCT IN COMMERCE
655,164 units (US) 3,294,426 units (International)
DISTRIBUTION
Nationwide, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, Côte d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-1810-2009
CODE
All system Serial Numbers C128 and higher with 2005 edition Robot Controller
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter dated June 22, 2009. Firm initiated recall is ongoing.
REASON
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
Nationwide and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand 
___________________________________
PRODUCT 
EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Recall # Recall # Z-1937-2009
CODE
Lot Number: 222090401, Serial Numbers: 27U000001 - 27U001700, Strip Expiration Date: 2010/09; Lot Number: 222090902: Serial Numbers: 27U001702 - 27U003401, Strip Expiration Date: 2010/11; Lot Number: 222091101, Serial Numbers: 27U003404 - 27U005903, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008404 - 27U008503, Strip Expiration Date: 2010/11; Lot Number: 222091102, Serial Numbers: 27U005904 - 27U008242, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008243 - 27U008430, Strip Expiration Date: 2010/11; and Lot Number: 222091201, Serial Numbers: 27U008504 - 27U010503, Strip Expiration Date: 2010/1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oak Tree International Holdings, LLC, Inc., Elyria, OH, by letter dated May 26, 2009.
Manufacturer: EPS Bio Technology Corp., Hsinchu City, Taiwan. Firm initiated recall is ongoing.
REASON
Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5,396 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021. The indications for use are routine MR imaging. Recall # Z-1938-2009
CODE
Serial Number: 070810, 070811, 100804, 100805, and X110810
RECALLING FIRM/MANUFACTURER
Quality Electrodynamics Llc, Cleveland, OH, by e-mail beginning December 29, 2008. Firm initiated recall is ongoing.
REASON
The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL, OH
___________________________________
PRODUCT 
1) Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-15301; and b) Catalog Number: 5-15401. Recall # Z-1940-2009;

2) Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-16028; b) Catalog Number: 5-16035; c) Catalog Number: 5-16037; d) Catalog Number: 5-16039; and e) Catalog Number: 5-16041. Recall # Z-1941-2009;

3) Hudson RICA Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-16128; b) Catalog Number: 5-16135; c) Catalog Number: 5-16137; d) Catalog Number: 5-16139; and e) Catalog Number: 5-16141. Recall # Z-1942-2009;

4) Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. Catalog Number: 5-16142. Recall # Z-1943-2009;

5)  Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: V5-16035; b) Catalog Number: V5-16037, c) Catalog Number: V5-16039; and d) Catalog Number: V5-16041. Recall # Z-1944-2009
CODE
1) a) Lot Numbers: 1132962, 1135424, 1136773, 1169645, 1173522, 1178399, 1188200, 1186993, 1194489,1201020, 1212344, 1258338, 1269036, 01L0700243, 01A0800245, 01C0800104, 01E0800341, 01F0800283, 01F0800354, 01L0800005, 01M0800250 and 01A0900036; and b) 5-15401, Lot Numbers: 1152620, 1153518, 1153626, 1155031, 1156400, 1156986, 1157666, 1160298, 1164076, 1169644, 1168080, 1172007, 1173521, 1182297, 1186762, 1193750, 1195118, 1276554, X1198365, X1198635, 01B0800103, 01F0800284, 01G0800362, 01H0800175, 01J0800015, 01A0900367 and 01D0900087;

2) a) Lot Numbers: 1163823, 1206612, 1223205, 1231357, 1244556, 1252502, X1240217, 01F0800193, 01F0800289 and 01L0800169; b) Lot Numbers: 1138516, 1140269, 1142027, 1143591, 1143610, 1143775, 1145101, 1145384, 1146183, 1148986, 1149631, 1150442, 1155626, 1157564, 1164122, 1165476, 1169574, 1170554, 1174447, 1178483, 1183447, 1185568, 1189653, 1194375, 1195121, 1201934, 1209310, 1210115, 1211569, 1216011, 1235840, 1238472, 1241371, 1241505, 1243845, 1244254, 1252504, 1258990, 1261906, 1263704, 1264908, 1263863, 1268698, 1271774, 1271775, 1274789, 1279285, 1280242, X1148352, X1158229, 01L0700413, 01L0700299, 01A0800102, 01B0800270, 01C0800185, 01D0800066, 01D0800257, 01F0800056, 01F0800191, 01F0800288, 01H0800056, 01H0800171, 01J0800458, 01J0800459, 01K0800275, 01K0800276, 01L0800292, 01L0800293, 01M0800058, 01M0800059, 01B0900229, 01C0900084, 01C0900345 and 01D0900001; c) Lot Numbers: 1134390, 1134620, 1135985, 1136800, 1137694, 1139466, 1140266, 1141630, 1143594, 1143781, 1145079, 1145383, 1146242, 1147855, 1149630, 1150443, 1152635, 1153621, 1158924, 1159137, 1165584, 1167116, 1170556, 1175203, 1176065, 1179985, 1183449, 1186327, 1188199, 1189032, 1190949, 1193073, 1193746, 1199353, 1200164, 1201040, 1212368, 1218623, 1224867, 1229983, 1230412, 1231358, 1232761, 1236305, 1237250, 1238139, 1239644, 1240215, 1245593, 1251482, 1252221, 1255615, 1263705, 1264907, 1266782, 1270819, 1273893, 1273896, 1277744, 1280243, 1280705, 1281123, X1179890, X1180634, X1181534, X1238185, 01L0700055, 01L0700056, 01L0700225, 01L0700300, 01M0700001, 01B0800021, 01B0800195, 01B0800356, 01C0800106, 01C0800186, 01D0800215, 01E0800063, 01E0800232, 01E0800328, 01F0800290, 01F0800355, 01G0800319, 01H0800403, 01J0800074, 01J0800149, 01J0800222, 01J0800223, 01K0800011, 01K0800038, 01K0800147, 01L0800067, 01L0800068, 01L0800523, 01L0800524, 01M0800206, 01M0800272, 01M0800317, 01A0900043, 01A0900125, 01C0900361; d) Lot Numbers: 1133790, 1135142, 1136768, 1139464, 1140267, 1142034, 1152984, 1156320, 1161353, 1162526, 1164081, 1167117, 1170557, 1171390, 1173367, 1173518, 1179984, 1184132, 1184133, 1186959, 1191585, 1198623, 1202821, 1205971, 1206609, 1207350, 1215046, 1215133, 1220397, 1225847, 1234644, 1238473, 1239645, 1240216, 1246654, 1252180, 1255614, 1263866, 1266009, 1270820, 1270821, 1271773, 1273897, 1273898, 1281125, 01K0700058, 01K0700359, 01L0700149, 01B0800196, 01B0800357, 01C0800351, 01D0800068, 01E0800133, 01E0800397, 01E0800398, 01G0800370, 01J0800328, 01J0800329, 01K0800503, 01K0800504, 01A0900044, 01B0900081 and 01B0900404; and e) Lot Numbers: 1144302, 1161067, 1167582, 1172627, 1175218, 1185570, 1190334, 1193744, 1197170, 1215132, 1228699, 1232762, 1233315, 1274787, 1280244, X1240255, 01K0700159, 01B0800358, 01E0800327, 01H0800058, 01H0800170 and 01M0800060;

3) a) Lot Numbers: 1169573, 1183453, 1186960, 1197168, 1205969, 1219532, 1233316, 1247807, 1256372, X1177389, 01K0800372 and 01D0900068; b) Lot Numbers: 1138507, 1141035, 1145947, 1146249, 1148606, 1151231, 1152184, 1157033, 1169746, 1174454, 1176787, 1186981, 1190223, 1193745, 1198626, 1242901, 1256154, 1274788, 1279286, 1281124, 01K0700161, 01L0700414, 01A0800144, 01H0800280 and 01K0800146; c) Lot Numbers: 1137695, 1140908, 1142035, 1144366, 1147062, 1148460, 1151236, 1152636, 1153628, 1154943, 1182363, 1187556, 1190332, 1192253, 1198625, 1241506, 1241616, 1244557, 1270823, 1278941, 1279287, X1158231, X1184238, X1189657, X49036, 01K0700357, 01L0700150, 01L0700226, 01E0800064, 01E0800132, 01E0800400, 01F0800057, 01F0800356, 01G0800167, 01K0800123, 01K0800384 and 01L0800167; d) Lot Numbers: 1136908, 1141067, 1142803, 1155672, 1162104, 1163822, 1172148, 1175219, 1179997, 1183450, 1190333, 1192254, 1219531, 1247271, 1270822, 1273899, 01K0700060, 01K0700258, 01C0800327, 01E0800399, 01F0800192, 01K0800385 and 01A0900218; and e) Lot Numbers: 1141964, 1162103, 1172149, 1185571, 1197167, X1176100 and 01C0800328;

4) Lot Numbers: 1162530, 1167118, 1169739, 1169740, 1190331, 1200165 and 1207348;

5) a) Lot Numbers: 1140268, 1140907, 1170555, 1178484, 1183448, 1194376, 1201935, 1208297, 1244546, 1275365, 01A0800182, 01D0800258, 01H0800057 and 01H0800402; b) Lot Numbers: 1145385, 1153622, 1158906, 1160679, 1163824, 1176066, 1182302, 1185569, 1190950, 1193074, 1199354, 1236306, 1246651, 1271778, 1278921, 1280706, 01K0700358, 01B0800201, 01C0800187, 01G0800445, 01J0800075 and 01A0900206; c) Lot Numbers: 1133751, 1152985, 1161068, 1164080, 1170555, 1176067, 1184133, 1191586, 1197169, 1198624, 1214179, 1215134, 1234645, 1266007, 166785, 1268697, 1271779, 01B0800049, 01B0800202, 01C0800352, 01G0800444 and 01A0900241; and d) Lot Numbers: 1167165, 1178485, 1197171, 1205970, 01K0700160 and 01K0800041
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by letters starting July 31, 2009.  
Manufacturer: Teleflex Medical, Inc., Tecate, B.C., Mexico. Firm initiated recall is ongoing.
REASON
The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
VOLUME OF PRODUCT IN COMMERCE
569,465 units
DISTRIBUTION
Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia
___________________________________
PRODUCT 
BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective. a) Catalog Number: 441242; and b) Catalog Number: 441244. Recall # Z-1963-2009
CODE
a) Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and b) Lot Number: 03T08218
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Diagnostics, GeneOhm Sciences, Inc., San Diego, CA, by telephone on November 17, 2008 followed by a letter dated November 21, 2008. 
Manufacturer: Bd Diagnostics Geneohm, Quebec, Canada. Firm initiated recall is ongoing.
REASON
BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.
VOLUME OF PRODUCT IN COMMERCE
114 kits
DISTRIBUTION
Nationwide, Belgium and Japan
___________________________________
PRODUCT 
1) Roche/Hitachi Preciset TDM I; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. Recall # Z-2000-2009;

2) Roche/Hitachi Preciset TDM II; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. Recall # Z-2001-2009
CODE
1) Lot Numbers: 15617400 and 15612200;
2) Lot Number: 15612300
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated April 22, 2009. Firm initiated recall is ongoing.
REASON
The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
VOLUME OF PRODUCT IN COMMERCE
3,970 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Roche ACCU-CHEK Performa blood glucose test strips, Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood. REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001. Recall # Z-2005-2009;

2) Roche ACCU-CHEK Performa blood glucose meters/kits. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood. REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023. Recall # Z-2006-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 10, 2009. Firm initiated recall is ongoing.
REASON
There may be a significant negative bias when testing neonate samples.
VOLUME OF PRODUCT IN COMMERCE
1,518 units
DISTRIBUTION
Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela
___________________________________
PRODUCT 
Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A, P/N: 70309-03900-101, Mfg P/N 3261165-0101. Z-2009-2009
CODE
Serial Numbers: Qualification Unit - 99251000003454 and 99251000008047; and Production Units - 000036019, 000036336, 000036429, 000029395, 000037473, 99251000100933, 99251000101044, 99251000101224, 99251000101545, 99251000102031, 99251000102144, 99251000102523, 99251000102612, 99251000049251, 99251000104094, 99251000103934, 99251000104405, 99251000049252, 99251000049253, 99251000049254 and 99251000049255
RECALLING FIRM/MANUFACTURER
Carleton Life Support Systems Inc., Davenport, IA, by letters dated July 24, 2009 and July 28, 2009. Firm initiated recall is ongoing.
REASON
The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
CT and AL

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT 
Oxytetracycline Hydrochloride Injection, 100 mg/ml, packaged in 500-ml. bottles, OTC, ANADA 200-068, under the following labels: (1) AmTech Group, Inc. Maxim 100, NDC 59130-673-03; (2) Butler Oxybiotic 100, NDC 11695-3533-3; (3) Terra-Vet 100 Injectable; (4) Durvet Duramycin-100, NDC 30798-577-17; and (5) Agripharm Oxy-Mycin 100. Recall # V-004-2010
CODE
Lot 7040565, Exp. 4/2010
RECALLING FIRM/MANUFACTURER
TEVA Animal Health, Inc., Saint Joseph, MO, by letters dated August 21, 2009. Firm initiated recall is ongoing.
REASON
Total filtration time exceeded specification and the product was not manufactured in conformance with GMP’s.
VOLUME OF PRODUCT IN COMMERCE
6,951/500-ml. bottles
DISTRIBUTION
OH, GA, FL, PA, IL, KY, NY, TN, TX, OR, UT, MO, IA, and TX
___________________________________
PRODUCT 
This medicated feed is packaged in 50 lb (net weight) white poly bags with the product label stitched to the bag seam. Labeling reads in part: "Net Weight 50 lbs. ***WST Pride PLUS AMPROLIUM CRUMBLE 1.25% For Beef and Dairy Calves***An aid in the prevention and treatment of coccidiosis***ACTIVE DRUG INGREDIENT Amprolium (Corid) 1.25%***" The firm's product number is "35016601". The label does not have a best by or expiration date. Recall # V-005-2010
CODE
Lot code: 11639-033109
RECALLING FIRM/MANUFACTURER
Western Stockmen’s, Caldwell, ID, by telephone on October 8, 2009. Firm initiated recall is ongoing.
REASON
Medicated feed was found to be sub-potent for Amprolium.
VOLUME OF PRODUCT IN COMMERCE
93/50 lb bags
DISTRIBUTION
OR, ID

END OF ENFORCEMENT REPORT FOR NOVEMBER 4, 2009

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