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Enforcement Report for May 14, 2008

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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May 14, 2008
08-20

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
a) Zebra Brand Sweetened Coconut, Net Wt. 170g (6 oz) --- Product of China ---
    ingredients: coconut, sugar --- --- Nutrition Facts: Serving Size Teaspoon
    (10g) -- Serving Per Bag 17 --- The product is packaged in a sealed, flexible plastic
    bag. Recall # F-321-8;
b) Zebra Brand Sweetened Lotusroot Seed, Net Wt. 170g (6 oz) --- Product of China,
     ingredients: lotus seed, sugar --- Nutrition Facts: Serving Size Teaspoon (10g) --   
     Serving Per Bag 17 --- The product is packaged in a sealed, flexible plastic bag.
     Recall # F-322-8
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega International Ltd. Inc., Brooklyn, NY, by press release on January 25, 2008.
Manufacturer: Hong Kong Ever Time Food & Grocery Co. Ltd., China. Firm initiated recall is complete.
REASON
The products contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Sweetened Coconut: 56 cases (50 - 6 oz. bags per case);
Sweetened Lotus Root Seed: 30 cases (50 - 6 oz. bags per case)
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
DELTA brand Golden Raisin, Net Wt. 16 oz. --- The product is packaged in a sealed plastic bag. Recall # F-323-8
CODE
No code
RECALLING FIRM/MANUFACTURER
Alaz Fine Food Corp., Brooklyn, NY, by press release on March 6, 2008. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (413 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
15 - 1 lb. packages
DISTRIBUTION
NY
___________________________________
PRODUCT
Frozen Mussel Meat (IQF 2 10x1 Kg Bag), Net weight 22.05 lbs., Sanford Brand, Product of New Zealand, sold in cardboard cases, 10 bags per case, Recall # F-324-8
CODE
All products with production date on the label between May 23 through November 21, 2007, Packhouse No. 177
RECALLING FIRM/MANUFACTURER
Recalling Firm: Union Fish Company, Alameda,CA, by letter on March 4, 2008.
Manufacturer: Sanford Ltd Auckland, Auckland, New Zealand. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Listeria Monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
869 cases
DISTRIBUTION
CA and HI
___________________________________
PRODUCT
a) Chocolate Covered Almonds, Net Wt 5 oz. (141g), Packed especially for Cracker    
    Barrel Old Country, Recall # F-325-8;
b) Chocolate Double Dipped Peanuts, Net Wt 5 oz. (141g), Packed especially for Cracker
    Barrel Old Country Store, Recall # F-326-8
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cracker Barrel Old Country Store, Lebanon, TN, by telephone on April 9, 2008
Manufacturer: Wythe Will Distributing, Lebanon, TN. Firm initiated recall is ongoing.
REASON
Chocolate Covered Almonds were labeled as Chocolate Double Dipped Peanuts and Chocolate Double Dipped Peanuts were labeled as Chocolate Covered Almonds.
VOLUME OF PRODUCT IN COMMERCE
5989 cases of 12
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Mrs Baird's Enriched Buns (4"), Net Wt 21 oz (1lb 5 oz) 595g; product packaged 12 buns per bag; UPC #70870 00374, Recall # F-327-8
CODE
Best By Date: April 8, 2008 and Best By Date: April 10, 2008
RECALLING FIRM/MANUFACTURER
Bimbo Bakeries USA Inc., Fort Worth, TX, by press release on April 1,2 008. Firm initiated recall is ongoing.  
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
7,524 units
DISTRIBUTION
OK, TX, LA, AR, MO, KS, TN, and MS.
__________________________________
PRODUCT
KORICA brand Dried Plum, Net Wt: 6oz (170g) +/- 5g --- Product of China --- Nutrition Facts: Serving Size 10 piece (25g) --- Servings Per Container About 2 --- The product is packed in a plastic jar. UPC barcode 6 868978 723376, Recall # F-329-8
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega International Ltd. Inc., Brooklyn, NY, by press release on February 4, 2008.
Manufacturer: Unknown. New York initiated recall is complete.
REASON
The product contained undeclared sulfites and non-permitted cyclamates based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
__________________________________
PRODUCT
a) Bass Pro Shops Uncle Buck's Light 'n Krispy Fish Batter Mix Original, packaged in
    8-oz. pouches and 22-oz. (623 g) canisters. The 22-oz. canister was also labeled for
    Canadian distribution. The labels show the product was produced and packaged for
    Bass Pro Shops. Recall # F-330-8;
b) Bass Pro Shops Uncle Buck's Light 'n Krispy Fish Batter Mix Hot & Spicy, packaged in 22-oz. canisters. The product is also labeled for Canadian distribution. The label shows the product was produced and packaged for Bass Pro Shops, Recall # F-331-8
CODE
a) 8 oz. pouches - Lot No. 3530716; 22 oz. jars - Lot No.'s 31207A11, 35107A11,
    06308A11;
b) Lot No. 06308A11
RECALLING FIRM/MANUFACTURER
Williams Foods Inc., Lenexa, KS, by telephone and e-mail on March 11, 2008, and March 13, 2008 and by press release on March 18, 2008. Firm initiated recall is ongoing.
REASON
An undeclared milk allergen was discovered in one of the product ingredients.
VOLUME OF PRODUCT IN COMMERCE
Original: 62/12/8-oz. pouch cs. & 1,070/12/22-oz. canister cs; Hot & Spicy: 140/12/22-oz. canister cs.
DISTRIBUTION
KS, MO, GA, VA, and MA.
___________________________________
PRODUCT
a) ICYBAY Brand Langostinos ,Cooked- IQF -Ready to eat 1 lb., clear plastic package.
    Packed 20 x 1 lb/Case Net Wt. 20 lb. Product of Chile; UPC 0-73129-61672-8, Recall
    # F-332-8;
b) IcyBay Langostinos, Cooked, IQF, Peeled . For Institutional Use. Packaged in five
    pound clear plastic packages containing, either 70-90 count, 90-125 count or
    120-150 count. Packed 4 x 5 lbs. Net Wt. 20 lbs. Product of Chile. Recall # F-333-8
CODE
a) Expiration date June 2009;
b) Production dates of July 18, 2007 through August 13, 2007 and/or Julian dates of 199
    through 232
RECALLING FIRM/MANUFACTURER
Recalling Firm: Slade Gorton & Company, Inc., Boston, MA, by telephone on March 13, 2008.
Manufacturer: Sociedad Guidomar Ltda, Coquimbo, Chile, Firm initiated recall is ongoing.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1754 cases (4x5lb) and 505 cases (20x1lb)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
America's Choice Classic Caesar Dressing. The product is sold in a 16 oz bottles. The product is shipped in cases containing 6 bottles. The label states distributed by The Great Atlantic & Pacific Tea Company, Recall # F-334-8
CODE
Best Before date: 02-09-09 62C/42302098
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bay Valley Foods, Westchester, IL, by telephone on March 30, 2008 and press release on March 31, 2008.
Manufacturer: Bay Valley Foods, LLC - North East, PA, North East, PA. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergens - fish, soy and wheat.
VOLUME OF PRODUCT IN COMMERCE
535 cases
DISTRIBUTION
CT, DC, DE, NJ, NY, and PA

___________________________________
PRODUCT
Pulmuone Leek and Oriental Noodle Fried Dumplings, 25.4 oz, UPC Code 8-801114-306338, Recall # F-335-8
CODE
Code Date: 2/2/2009, 2/9/2009, 3/6/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pulmuone Wildwood Inc., Fullerton, CA, by telephone on April 14 – 15, 2008 and by letters on April 22, 2008.
Manufacturer:  Pulmuone Co Ltd., Seoul, Korea, Republic Of (South). Firm initiated recall is complete.
REASON
Product is labeled incorrectly. The product labeled as Leek and Oriental Noodle Fried Dumpling lists albumen as an ingredient but does not list egg as a source of the albumen as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
Approximately 12,000 units (1,000 cases)
DISTRIBUTION
CA, IL, TX, GA
___________________________________
PRODUCT
Chang Farm brand Soy Sprouts, Net Wt. 12 oz (340 g) in plastic bag Refrigerate All Natural Ready to Cook, Recall # F-336-8
CODE
SELL BY 04/19/08
RECALLING FIRM/MANUFACTURER
Chang & Son Enterprises, Inc., Whately, MA, by telephone and fax on April 17, 2008. Massachusetts initiated recall is ongoing.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
486 lbs
DISTRIBUTION
MA, CT
___________________________________
PRODUCT
S'morestick Kit, net wt. 18 oz., each kit includes 4 30 in. sticks, 1 bag of chocolate, 1 bag of marshmallows, 1 package of graham crackers, campfire songs, and The History of S'mores, Recall # F-337-8
CODE
Use by 02/14/09
RECALLING FIRM/MANUFACTURER
Grand Carnival Manufacturing LLC., Fenton, MO, by telephone on April 10, 11, 14,  2008 and by e-mail on April 14, 2008. Firm initiated recall is complete.
REASON
Milk was not declared as an ingredient on the kit label.
VOLUME OF PRODUCT IN COMMERCE
200/18/18-oz. kit cases
DISTRIBUTION
TX
___________________________________
PRODUCT
HC Fresh brand Frozen Salted Croaker, Net Wt. 16.9 oz, UPC Barcode - 0761898 633984, Recall # F-338-8
CODE
Expiry - 2009 08 02, Item # HC 0500402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grand Super Center Inc., Lyndhurst, NJ, by letters on April 1, 2008 and by e-mail on March 24, 2008.
Manufacturer: Hee Chang Trading Co., Ltd., Busan, Republic of (South) Korea. Firm initiated recall is complete.
REASON
NJDHSS discovered this product to be uneviscerated during a routine inspection. This could lead to potential contamination with Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
46 cartons
DISTRIBUTION
NJ, NY, PA, IL, and FL
___________________________________
PRODUCT
a) Rel's Roast Beef & Cheese sandwich Double Fill, Net Weight 10 oz. (284g) in plastic
    wrap, UPC: 751935 00443, Recall # F-339-8;
b) Rel's Pesto Chicken with Provolone pita sandwich, Net Wt 6 oz. in plastic wrap,
    UPC: 751935 01134, Recall # F-340-8
CODE
Date code 03 28
RECALLING FIRM/MANUFACTURER
Rel's Foods, Oakland, CA, by text message to route driver on March 27, 2008.
Firm initiated recall is ongoing.
REASON
Products may be contaminated with Listeria Monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Total 1102 sandwiches
DISTRIBUTION
NV and CA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
GFS Ultra-Pasteruized Non-Dairy Creamer, Product # 8881574, 464 3/8 Fl. oz. containers per case. Cases have Net Wt 11 lbs 9 oz, Reorder No. 427233, and UPC 0 00 93901 427236, Recall # F-320-8
CODE
Lot #APR088W024 (only on cases) Use by 04/08/2008
RECALLING FIRM/MANUFACTURER
Kohler Mix Specialties of Minnesota, LLC., White Bear Lake, MN, by telephone on March 12, 2008. Firm initiated recall is complete.
REASON
Product labeled as Half & Half actually contains Non-Dairy Creamer with soy lecithin as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
2016 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Belmont Apple Deep Dish, Net Wt. 42 oz (2 lb 10 oz) 1.19 Kg., M104.229CT,
    Recall # F-315-8;
b) Mrs. Smiths Restaurant Classic HEATH Crunch Pie, Keep Frozen. Thaw and Serve.
    Serve Chilled. Do Not Refreeze., Net Wt 40 oz (2 lbs 8 oz) 1.13 Kg., 8 053.
    Shipping case- Mrs. Smith's Restaurant Classics 10" Pies, 10" Thaw & Serve
    Cream/Meringue Pies 4000964 Health Crunch 8W 08053 02 22 08, Recall # F-316-8;
c) J. Horner's Banana Cream Pie, Net Wt 26 oz (1 lb 10 oz), KEEP Refrigerated.
    Shipping case; 07434 CH 2008053, Banana Cream Pie, Count per case 6 ea, Case
    Weight 12 lb 12 oz, Recall # F-317-8;
d) Bakers Square French Silk Pie, Net Wt 34 oz (2 lb 2oz), CH 2008053 08053,
    Shipping case; 07946 CH 2008053, French Silk Pie, Count Per Case 6 Ea., Case
    Weight 16 lb. 12 oz. Recall # F-318-8;
e) 10" TFF Country Apple Pie, Count Per Case 6 ea, Case Weight 25 lb 20z, 08205
    CH 2008053,  CH08053 APPLETFF, Recall #  F-319-8;
CODE
a) Best by Feb 16 09;
b) 8W08053;
c) 2008053,
d) 2008053
e) 2008053, Best by 02/16/2009
RECALLING FIRM/MANUFACTURER
Vicom, Chaska, MN, by telephone and email on March 4, 2008. Firm initiated recall is ongoing.
REASON
Pies are manufactured using flour, which may contain small plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
2420 cases
DISTRIBUTION
MI, WI, IL, MO, IA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

__________________________________
PRODUCT
Stonyfield Organic Fat Free Blueberry Yogurt, 6 oz cup, Recall # F-311-8
CODE
Use By dates: Apr 13 08; Apr 14 08; Apr 15 08; Apr 25 08; Apr 26 08
RECALLING FIRM/MANUFACTURER
Stonyfield Farm, Londonderry, NH, by letter on March 28, 2008. Firm initiated recall is complete.
REASON
Yogurt may contain small foreign objects.
VOLUME OF PRODUCT IN COMMERCE
22901 cases
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Gia Russa Miniature Bow Tie Chicken Flavored Noodle Soup, in Net Wt. 5 oz cellophane packets. The product is distributed 12 x 5 oz. packets per case. The UPC codes subject to recall were: Gia Russa 12/5 oz Small Bow Tie Soup - UPC #26825-01109; and Gia Russa 72/5 oz Small Bow Tie Soup Shipper - UPC #26825-01122,
Recall # F-312-8
CODE
Uncoded. All products distributed from May, 2007 through October, 2007 was subject to recall
RECALLING FIRM/MANUFACTURER
Recalling Firm: John Zidian Co Inc., Youngstown, OH, by e-mail on March 3, 2008.
Manufacturer: Royal Products International Inc., Lodi, OH. Firm initiated recall is ongoing.  
REASON
The pasta ingredient of the firm's chicken flavored soup was found to contain live insect larvae. Upon contacting the firm, following the receipt of an FDA consumer complaint (CC #58853), it was learned that the affected product had been voluntarily recalled by the firm
VOLUME OF PRODUCT IN COMMERCE
2222 cases
DISTRIBUTION
NY
__________________________________
PRODUCT
a) Naked Juice Protein Zone All Natural Protein Juice Smoothe; 15.2 oz & 32 oz,
    Recall # F-313-8
b) Trader Joe's Protein with Pzazz, 15.2 oz, Recall # F-314-8
CODE
a) Lot Numbers: 002B7360M, 002A7361M, 002A7361M, 002A7361M;
b) Lot Number: 002B7360M
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Naked Juice Co., Inc., Azusa, CA, by letters on January 18, 2008.
Manufacturer: Beverage Concepts, Inc., Rancho Santa Margarita, CA. Firm initiated recall is complete.
REASON
Product contains yeast and lactic acid bacteria.
VOLUME OF PRODUCT IN COMMERCE
18,003 cases
DISTRIBUTION
Nationwide
___________________________________

PRODUCT
Looney Tunes Valentine Candy Watches & Bracelets, made in China, Net Wt. 14.8 oz (420g), UPC code 752041-21413. Recall # F-328-8
CODE
Production date Y29007
RECALLING FIRM/MANUFACTURER
Recalling Firm: H E B, San Antonio, TX, by press release, e-mail and telephone on February 15, 2008.
Manufacturer: Unknown. Firm initiated recall is complete.
REASON
Ready to eat snack food has potential for containing a foreign object.
VOLUME OF PRODUCT IN COMMERCE
5,736 retail packs
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

__________________________________
PRODUCT
BP Balance AF (Enhanced BP Balance), Original Chinese formula, Herbal supplement, 250 milligram Vegetarian Caplets, 100 count and 200 count bottles, Recall # D-204-2008
CODE
There are no codes or lot numbers assigned to these products.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Geromatrix Health Products, Boca Raton, FL, by website, e-mail and letter on April 9, 2008
Manufacturer: Active Nutraceuticals, Carrollton, GA. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains undeclared promethazine.
VOLUME OF PRODUCT IN COMMERCE
185 containers of 100 count.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a)  Schwarz Pharma Neupro (rotigotine transdermal system) 2 mg/24 hours, Rx, 7
    systems (NDC 0091-6486-21); 30 systems (NDC 0091-6486-01); and
    PROFESSIONAL SAMPLES - Not for sale, Recall # D-205-2008;
b) Schwarz Pharma Neupro (rotigotine transdermal system); 4 mg/24 hours, Rx, 7
    systems (NDC 0091-6487-21); 30 systems (NDC 0091-6487-01); and
    PROFESSIONAL SAMPLES - Not for sale, Recall # D-206-2008;
c) Schwarz Pharma Neupro (rotigotine transdermal system); 6 mg/24 hours, Rx, 7
    systems (NDC 0091-6488-21); 30 systems (NDC 0091-6487-01); and
    PROFESSIONAL SAMPLES - Not for sale, Recall # D-207-2008;
d) Schwarz Pharma Neupro Titration Kits (rotigotine transdermal system); Kits contain:
    7 patches, 2 mg/24 hours, -7 patches, 4 mg/24 hours, -7 patches, 6 mg/24 hours, Rx
    only, NDC 0091-6480-99, Recall #  D-208-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schwarz Pharma Manufacturing, Seymour, IN, by letters dated March 21, 2008.
Manufacturer: Lohmann Thereapie-Systeme AG, Andernach, Germany. Firm initiated recall is ongoing.
REASON
Crystallization; active ingredient is forming crystals, which may result in a lower dose being delivered.
VOLUME OF PRODUCT IN COMMERCE
1,090,814 packages
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
InVite brand Yeast Rice Extract, Herbal Support For Cholesterol Levels Already Within a Normal Range, 600 mg, Dietary Supplement, 120 capsules, UPC 6 66782 50525 8, Recall # D-210-2008
CODE
Lots: 0710106 (exp. 10/2010) and 0704020 (04/2010)
RECALLING FIRM/MANUFACTURER
Bactolac Pharmaceutical, Inc., Hauppauge, NY, by letters dated March 28, 2008. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain Lovastatin, the active pharmaceutical ingredient in Mevacor.
VOLUME OF PRODUCT IN COMMERCE
2247 bottles
DISTRIBUTION
NY and NJ

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

__________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1185-08
CODE
Unit: 4248278
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1358-08
CODE
Units: 18GT20580
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, Mi, by telephone on June 26, 2007 and follow-up letter dated July 10, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not undergo quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1360-08
CODE
Unit: 71X15314X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on March 4, 2006.
Manufacturer: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL. 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
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1369-08
CODE
Units: 71R46171-2, 71R46176-1, 71R46182-8, 71R46183-X, 71R46187-7, 71R46234-0, 71R46246-8, 71R62291-7, 71R13828-7, 71R13829-9, 71R13831-8, 71R45232-2, 71R45233-4, 71R45235-8, 71R45239-5, 71R45461-6, 71R45462-8
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on February 1, 2006.
Manufacturer: LifeSouth Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood components, processed from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
AL
__________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1382-08
CODE
Unit: 6874856
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on March 10, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Fresh Frozen Plasma unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1383-08
CODE
Unit: 6978564
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on December 27, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
__________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1384-08
CODE
Unit: 6738788
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on March 15, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Fresh Frozen Plasma unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0399-08
CODE
Unit: 29GM28404
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone on September 29, 2006 and letter dated October 12, 2006. Firm initiated recall is complete.
REASON
Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
__________________________________
PRODUCT
Source Plasma, Recall # B-1183-08
CODE
Units: GZ036528, GZ036100, GZ035920, GZ035663 and GZ035540
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by facsimile on August 10, 2007. 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
5 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-1184-08
CODE
Unit: 4849522
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
__________________________________
PRODUCT
Source Plasma, Recall # B-1385-08
CODE
Unit: 06RMID7667
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Kentwood, MI, by facsimile on November 29, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product      Numbers 9012B1011 and 9012B1001, Recall # Z-0517-2008
CODE
No devices are being returned. The field action is being done to communicate and emphasize the current Instructions for Use (IFU) regarding detachment of the Capsule from the Delivery System.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter in December 2007.
Manufacturer: Arizona Device Mfg., Tempe AZ. Firm initiated recall is ongoing.
REASON
Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
VOLUME OF PRODUCT IN COMMERCE
169,365
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O, Recall # Z-1118-2008
CODE
Lot Numbers: hCG6120203, hCG6120204, hCG7010080, hCG7010081, hCG7010038, hCG7010039, hCG7010040, hCG7030144, hCG7030145, hCG7030146, hCG7040076, hCG7040077, hCG7040078, hCG7040079, hCG7050121, hCG7050122, hCG7060073, hCG7060216, hCG7070042, hCG7070043, hCG7070044, hCG7007045, hCG7070060, hCG7070061, hCG7070186, hCG7070187, hCG7070191, hCG7080182, hCG7090049, hCG7090050, and hCG7090052
RECALLING FIRM/MANUFACTURER
Recalling Firm: Innovacon Inc., San Diego, CA, by letter dated October 1, 2007.
Manufacturer: Abon Biopharm (Hangzhou) Co., Ltd, Hangzhou, Zhejiang, China. Firm initiated recall is ongoing.
REASON
Incorrect results; The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.
VOLUME OF PRODUCT IN COMMERCE
1,825,480 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ADVIA Centaur HAV lgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Recall # Z-1119-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions Diagnostics, East Walpole, MA, by letter on January 12, 2008. Firm initiated recall is ongoing.
REASON
Incorrect results; False reactive specimens on the ADVIA Centaur HAV lgM assay.
VOLUME OF PRODUCT IN COMMERCE
49,533 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ev3 IntraStent Biliary Stent, Model Number: S10-26, Catalog Number: 90-0648-001,
    Recall # Z-1120-2008;
b) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, Catalog Number:
    90-0952-000, Recall # Z-1121-2008;
c) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, Catalog Number:
    90-0952-001, Recall # Z-1122-2008;
d) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, Catalog Number:
    90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36,
    Catalog Number: 90-1075-002 (not approved within the USA), Recall # Z-1123-2008;
e) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16,
    Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter
    Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not
    approved within USA), Recall # Z-1124-2008;
f) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36,
    Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter
    Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not
    approved within USA), Recall # Z-1125-2008;
g) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16,
    Catalog Number: 90-2313-000 ev3 IntraStent LD Mega Large Diameter Peripheral
    Stent, Model Number: S17-16, Catalog Number: 90-2336-000 (not approved within
    USA), Recall # Z-1126-2008;
h) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26,
    Catalog Number: 90-2313-001. ev3 IntraStent LD Mega Large Diameter Peripheral
    Stent, Model Number: S17-26, Catalog Number: 90-2336-001 (not approved within
    USA), Recall # Z-1127-2008;
i) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36,
    Catalog Number: 90-2313-002. ev3 IntraStent LD Mega Large Diameter Peripheral
    Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within
    USA), Recall # Z-1128-2008;
j) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16,
    Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral
    Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within
    USA), Recall # Z-1129-2008;
k) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26,
    Catalog Number: 90-2319-001. ev3 IntraStent LD Max Large Diameter Peripheral
    Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within
    USA), Recall # Z-1130-2008;
l) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36,
    Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Peripheral
    Stent, Model Number: S18-36, Catalog Number: 90-2337-002. (not approved
    within USA), Recall # Z-1131-2008

CODE
a) Lot Number: 2099706;
b) Lot Numbers: 2709041, 2537571, and 4493725;
c) Lot Number: 3604128;
d) Lot Numbers: 2418012, 2703169, and 1688108;
e) Lot Numbers: 2767839, 2715678, and 2790795;
f) Lot Numbers: 2722702, 2099726, and 1831865;
g) Lot Numbers: 3548016, 1940595, 1501170, 2417423, and 2313515;
h) Lot Numbers: 1646893, 1940629, 1940630, 2107072, 2293418, 2838055, 2563128,
    2417407, 2829684, and 3293069;
i)  Lot Numbers: 1646894, 2107075, 2107080, 2703209, 1879156, 2417413, and
    1695067;
j) Lot Numbers: 3766729 and 2417395;
k) Lot Numbers: 1879157, 1940667, 2429814, 2431937, 1646895, 3151708, 3104952,
    2601011, 2107071, 2036017, 4206244, 2036018, and 2829735;
l) Lot Numbers: 1788817, 1940694, 1979985, 2356512, 1831905, 3170756, 2681547,
   1940695, 2158549, 3182196, 3003378, 3013044, 1688027, 1688029, 3002623,
    2968850, 1688030, 1688031, and 1979986
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter on January 18, 2008. Firm initiated recall is ongoing.
REASON
Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
VOLUME OF PRODUCT IN COMMERCE
949
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008
CODE
iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on January 21, 2008.  Firm initiated recall is ongoing.
REASON
Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
VOLUME OF PRODUCT IN COMMERCE
196 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking
    syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic,
    isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of
    heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride
    in water for injection. The pre-filled syringes were packed 60 syringes per dispenser
    box, 16 boxes per shipping carton in the following syringe configurations:
    a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe,
    b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe,
    c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe,
    Recall # Z-1543-2008;
b) Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe
    containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic
    injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium
    derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for
    injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes
    per shipping carton in the following syringe configurations:
    a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe;
    b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe,
    Recall # Z-1544-2008;
c) Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe
    containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic
    injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium
    derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for
    injection; The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box,
    16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425,
    Recall # Z-1545-2008
CODE
a) a) Catalog #MIH-3335: lot H107301, exp. date 09/09; H107305, exp. date 09/09;
    H107309, exp. date 10/09; H107313, exp. date 10/09; H107317, exp. date 10/09; 
    H107322, exp. date 10/09; H107340, exp. date 11/09; H108111, exp. date 12/09;
    H108116, exp. date 12/09; H108122, exp. date 01/10; H108127, exp. date 01/10;
    b) catalog #MIH-3333: lot H107332, exp. date 11/09; H108106, exp. date 12/09;
    H108118, exp. date 12/09;
    c) catalog #MIH-3323: lot H108117, exp. date 12/09;
b) Catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09;
    catalog #MIH-2233: lot H08124, exp. date 01/10;
c) Catalog #MIH-4425: lot H207335, exp. date 11/09
RECALLING FIRM/MANUFACTURER
Medefil, Inc., Glendale Heights, IL, by telephone on March 20, 2008, and by e-mail and letter on March 21, 2008 and March 24, 2008. Firm initiated recall is ongoing. 
REASON
The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.
VOLUME OF PRODUCT IN COMMERCE
3,713,040 syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml,
    REF # 8881580121, Recall # Z-1594-2008;
b) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL
    REF # 8881580123, Recall # Z-1595-2008;
c) Tyco Healthcare Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush
    Syringe 5mL REF # 8881580125, Recall # Z-1596-2008;
d) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL
    in 3mL syringe REF # 8881580300, Recall # Z-1597-2008;
e) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL,
    with BLUNTIP plastic cannula REF # 8881581125, Recall # Z-1598-2008;
f) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL
    REF # 8881590121, Recall # Z-1599-2008;
g) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL
    REF # 8881590123, Recall # Z-1600-2008;
h) Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL
    REF # 8881590125, Recall # Z-1601-2008;
i) Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL,
    with BLUNTIP plastic cannula REF # 8881591125, Recall # Z-1602-2008
CODE
a) Lot Numbers: 7082274; 7113214;
b) Lot Numbers: 7051524; 7113214;
c) Lot Numbers: 7051524; 7082274; 7113164; 7113174;
d) Lot Number: 7051444;
e) Lot Number: 7082274;
f) Lot Number: 7113064;
g) Lot Numbers: 7041194; 7072154; 7113034; 8010194;
h) Lot Numbers: 7041194; 7102804; 7041204; 7113034; 7051534; 7113044;
    7051544; 7113054; 7051554 ; 7113104; 7071924 ; 7113114; 7072034; 7113154;
    7072044; 8010064; 7072054; 8010114; 7072064 ; 8010134; 7072154; 8010174;
    7082284;
i) Lot Number: 7082284;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, by letter beginning March 28, 2008, through April 1, 2008.
Manufacturer: Covidien, Montreal, Quebec, Canada. Firm initiated recall is ongoing.
REASON
Scientific Protein Laboratories (SPL) disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient have a heparin-like contaminant.
VOLUME OF PRODUCT IN COMMERCE
11,054,950
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
a) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item
    number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis
    kit, Recall # Z-1035-2008;
b) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item
    number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis
    kit, Recall # Z-1036-2008
CODE
a) Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06;
b) Lot Number 07G04 exp 2012-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter dated December 12, 2007.
Manufacturer: B. Braun Carex SpA, Mirandola (MO), Italy. Firm initiated recall is ongoing.
REASON
Faulty tubing does not prime machine as intended.
VOLUME OF PRODUCT IN COMMERCE
2,500 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, UPC Code: 30003-020917 and UPC Code: 30003-020917, Recall # Z-1179-2008
CODE
Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N and 7F1816N;
Added 2/21/07 - Lot 7F2009N. 4-14-08: 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ, by letters on February 14, 2008, February 21, 2008 and April 10, 2008.
Manufacturer: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. Firm initiated recall is ongoing.
REASON
Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
VOLUME OF PRODUCT IN COMMERCE
3,986 market units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LIASON® 25-OH Vitamin D Kit, Vitamin D test system, Model Number 310900, Recall # Z-1240-2008
CODE
Lot Numbers: 120422 and 120423
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter sent by e-mail on February 1, 2008. Firm initiated recall is ongoing.
REASON
Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
VOLUME OF PRODUCT IN COMMERCE
2,267 units
DISTRIBUTION
Nationwide and Austria

__________________________________
PRODUCT
a) Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm,
    .070 in (internal dia), shaft length, 90 cm, Catalog Number: 34356-446,
    UPN H749343564460, Sterile EO, Recall # Z-1300-2008;
b) Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in
    (internal dia), Shaft length 55cm, Catalog Number: 19-600, UPN M001196000,
    Sterile EO, Recall # Z-1301-2008;
c) Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm,
     .070 in (internal dia), Shaft length 90cm, Catalog Number: 19-626, UPN
    M001196260, Sterile EO, Recall # Z-1302-2008;
d) Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve,
    .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-666, UPN M001196660,
    Sterile EO, Recall # Z-1303-2008;
e) Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in
    (internal dia), Shaft length 55cm, Catalog Number: 19-723, UPN M001197230,
    Sterile EO, Recall # Z-1304-2008;
f) Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve,
    .091 in (internal dia), Shaft length 55cm, Catalog Number: 19-866, UPN M001198660,
    Sterile EO, Recall # Z-1305-2008
CODE
a) Lot Number: 20022689;
b) Lot Number: 20025890;
c) Lot Numbers: 20034251 and 20025906;
d) Lot Number: 20030656;
e) Lot Number: 20030666;
f) Lot Number: 20039169
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on February 7, 2008.
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Mislabeled: Seven lots/batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS I

___________________________________
PRODUCT
Diamond Pet Foods Nutra Nuggets Lamb Meal and Rice formula dog food in 40 lb. yellow and green paper bag, Recall # V-031-2008
CODE
Production codes of NLR0404A2SL or NLR0404B2SL, “Best Before” Oct. 9, 2008
RECALLING FIRM/MANUFACTURER
Diamond Pet Foods, Lathrop, CA, by press release and letters on May 23, 2007. Firm initiated recall is ongoing.
REASON
Product is contaminated with melamine.
VOLUME OF PRODUCT IN COMMERCE
6,064 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Hartz Vitamin Care for Cats and Kittens; Net contents: 100 chewable tablets; Feeding instructions: Kittens – ½ to 1 tablet daily; Cats -1 – 2 tablets daily. UPC 32700-97701, Recall # V-036-2008
CODE
Lot: SZ22771
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hartz Mountain Corp., Secaucus, NJ, by press release on March 7, 2008 and letters via e-mail on March 7 – 10, 2008.
Manufacturer: UFAC (USA) Inc., Baconton, GA. Firm initiated recall is ongoing.
REASON
FDA sampling of product had positive results for the presence of salmonella.
VOLUME OF PRODUCT IN COMMERCE
888 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS II

___________________________________
PRODUCT
SurgiVet V6004 NIBP Monitor, Recall # V-043-2008
CODE
AJ07080083 AJ07080085 AJ07080064 AJ07080066 AJ07080067 AJ07080073 AJ07080070 AJ07080068 AJ07080069 AJ07080072 AJ07080077 AJ07080060 AJ07080061 AJ07080074 AJ07080065 AJ07080076
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter on April 2, 2008. Firm initiated recall is ongoing.
REASON
The tantalum capacitor located at C5 on the V64004 display board of the Smith Medical PM, Inc., BCI ®Mini-Torr Plus® NIBP Monitor with SpO2 Built-In Printer, may be reverse polarized. As a result the monitor may turn off or the monitor may immediately reset.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
PA, AL, WI, TX, NM, LA, Canada, Ecuador, Hong Kong

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS III

___________________________________
PRODUCT
a) Lamb Wise brand Lamb & Sheep Feed 20% Lamb Pre-Str Medicated, in 50 lb paper
    bags. The labeled content of Chlorotetracycline was 50 gms/ton, Recall V-039-2008;
b) Nutra Beef Cattle Grower brand #4 Bull R 30, produced and sold in bulk. Product is
    medicated feed containing Rumensin 80 (Monensin), Recall # V-040-2008;
c) Miller Feed Lot 45/27 472g Mon, a custom feed with no brand name. Product is
    produced and sold in bulk. Product is medicated feed containing Rumensin 80  
    (Monensin), Recall # V-041-2008;
d) Llama Mineral, a custom feed with no brand name, in 50 lb paper bags. Product is a
    non-medicated feed, Recall # V-042-2008
CODE
a) Lot: 2P8035 275, Mfg product identifier code: 52176 (2P = Billings facility, 8 = year,
    035 = Julian date, 275 = run number);
b) Lot: 2P7309 1843, Mfg product identifier code: 92187-A (2P = Billings facility,
    7 = year, 309 = Julian date, 1843= run number);
c) Lot: 2P7323 1966, Mfg product identifier code: 870143-MF (2P = Billings facility,
    7 = year, 323 = Julian date, 1966= run number);
d) Lot: 2P8008 072, Mfg product identifier code: 051251-B (2P = Billings facility,
    8 = year, 008 = Julian date, 072= run number)
RECALLING FIRM/MANUFACTURER
Cargill, Inc., Billings, MT, by telephone on February 22, 2008 and April 1, 2008. Firm initiated recall is complete.
REASON
Product contains excessive and undeclared amounts of Chlortetracycline.
VOLUME OF PRODUCT IN COMMERCE
34.15 tons total: Lamb & Sheep -16, 50 lb bags, Cattle Grower - 24.07 tons, Miller Feed Lot - 5.68 tons, Llama mineral - 159, 50 lb bags
DISTRIBUTION
MT and WY

END OF ENFORCEMENT REPORT FOR MAY 14, 2008

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