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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 4, 2011

 

May 4, 2011                                                                                        11-18
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Sourdough Wheat Bread, 2 lb. loaf is packaged in a clear plastic bag with twist tie. This product has a UPC 832118001255. The product is labeled in part: "SOURDOUGH WHEAT BREAD***NET WT. 2 lb*** INGREDIENTS: Fresh stone ground organic whole grain wheat flour, organic unbleached wheat flour, water, natural sourdough starter (from organic wheat), salt (May contain sunflower seed, poppyseed, flaxseed, and sesame seed)***". Recall # F-1000-2011;
 
2) Oatmeal Bread, 1 lb. 8 oz loaf is packaged in a clear plastic bag with twist tie. This product has a UPC 832118001057. The product is labeled in part: "OATMEAL BREAD***NET WT. 1 lb 8 oz***INGREDIENTS: Stone ground organic whole grain wheat flour, organic oat flakes, water, honey, yeast, salt***". Recall # F-1001-2011;
 
3) Garlic Basil Parmesan Bread, 16 oz. baguette is packaged in a clear plastic bag with twist tie. This product has a UPC 832118001156. The product is labeled in part: "GARLIC BASIL PARMESAN BREAD***NET WT. 16 oz*** INGREDIENTS: Fresh stone ground organic whole grain wheat flour, organic unbleached wheat flour, water, fructose, Parmesan cheese (milk), yeast, garlic, basil, salt***". Recall # F-1002-2011
CODE
1) Pull dates: 03-31; 04-02; and 04-05;
2) and 3) Pull dates: 03-31
RECALLING FIRM/MANUFACTURER
Cottage Grove Farmhouse Bakery, Cottage Grove, OR, by telephone and visits beginning March 30, 2011 and by press release on April 1, 2011. Firm initiated recall is ongoing.
REASON
Undeclared Allergen. Oatmeal Bread, Garlic Basil Parmesan, and Wheat Sourdough Bread contained egg whites, but egg whites were not declared on label.
VOLUME OF PRODUCT IN COMMERCE
1) 137 loaves; 2) 68 loaves; 3) 42 loaves
DISTRIBUTION
OR
___________________________________
PRODUCT
1) Winfrey's Fudge & Chocolates Dark Caramello, chocolate covered caramel pieces, sold in bulk 5 lb. units. Recall # F-1003-2011;
 
2) Winfrey's Fudge & Chocolates Milk Caramello, chocolate covered caramel pieces, sold in bulk 5 lb. units. Recall # F-1004-2011;
 
3) Winfrey's Fudge & Chocolates Dark Scott-Mallow, chocolate covered marshmallow pieces, sold in bulk 5 lb. units. Recall # F-1005-2011;
 
4) Winfrey's Fudge & Chocolates Milk Scott-Mallow, chocolate covered marshmallow pieces, sold in bulk 5 lb. units. Recall # F-1006-2011
CODE
1) Lot #0211;
2) Lot #0211;
3) Lot #0211, 0711
4) Lots #0211, 0511
RECALLING FIRM/MANUFACTURER
Winfrey's Olde English Fudge Inc., Rowley, MA, by visit between March 31, 2011-April 1, 2011. Firm initiated recall is complete.
REASON
Undeclared egg, a sub-ingredient of frappe or Fondax.
VOLUME OF PRODUCT IN COMMERCE
87 - 5 lb. units (160 pieces each)
DISTRIBUTION
MA
___________________________________
PRODUCT
1) Cottage Hearth Stone Ground Wheat Bread, 24 oz UPC Number: 0-41380-80625-7. Recall # F-1007-2011;
 
2) 7 Select 100% Whole Wheat Bread, 24 oz, UPC Number: 0-52548-00181-0. Recall # F-1008-2011
CODE
Code date: Mar. 26
RECALLING FIRM/MANUFACTURER
Unified Grocers Inc., City Of Commerce, CA, by press release on March 18, 2011 and March 23, 2011. Firm initiated recall is ongoing.
REASON
Unified Grocers is recalling Cottage Hearth Stone Ground Wheat Bread (24 oz) and 7 Select 100% Whole Wheat Bread (24 oz) because they may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
833 units
DISTRIBUTION
CA, AZ
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Oak Farms Dairy 1% Chocolate Lowfat Milk Vitamin A&D 1% Milkfat Half Pint (236 mL). Recall # F-1012-2011;
 
2) Oak Farms Chocolate Milk Half Pint (236 mL). Recall # F-1013-2011;
 
3) Oak Farms Dairy Chocolate Whole Milk Half Gallon (1.89L). UPC 0 41271 00724 4. Recall # F-1014-2011
CODE
1) SELL BY MAR 22D Plant Code 48-3302 embossed on gable top;
2) SELL BY MAR 22B Plant Code 48-3302 embossed on gable top;
3) BEST BY 03/22/11 483302B
RECALLING FIRM/MANUFACTURER
Oak Farms Waco, Waco, TX, by press release and letters on March 11, 2011. Firm initiated recall is ongoing.
REASON
Product recalled due to the presence of Alkaline Phosphatase found in samples during routine testing.
VOLUME OF PRODUCT IN COMMERCE
64,130 bottles
DISTRIBUTION
TX
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT   
1) Whole Stemless S4 Chilies 50 lb bags (Labeled as: "BOAT BRAND PREMIUM GRADE WHOLE STEMLESS S4 CHILLIES ETO TREATED NET WT.: 50LB PRODUCT OF INDIA ***"). Recall # F-1010-2011;
 
2) Whole with stem S4 Chilies 50 lb bags (Labeled as: "BOAT BRAND PREMIUM GRADE WHOLE STEM S4 CHILLIES ETO TREATED NET WT.: 50LB PRODUCT OF INDIA ***"). Recall # F-1011-2011
CODE
1) Lot # 3066, 3047, 3049;
2) Lot # 3048
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spice & Spice, Inc., Rolling Hills Estates, CA, by telephone on February 18, 2011 and by letter on March 17, 2011.
Manufacturer: ITC Limited, Guntur, India. Firm initiated recall is ongoing.
REASON
The recall was initiated because Spice and Spice Inc. has confirmed the whole stemless S4 chilies and Whole with stem S4 chilies are contaminated with pesticide chemical contaminates. The affected products were refused by FDA and they were shipped out to customers by Red Hot Chilies, a third party warehouse.
VOLUME OF PRODUCT IN COMMERCE
939 total bags
DISTRIBUTION
CA, NC. TX
 
RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT   
Cisplatin Injection, 50 mg/50 mL (1 mg/mL), 50 mL Multiple Dose Vial, Rx only; NDC 0703-5747-11. Recall #D-445-2011
CODE
Lot # 10C16NA, Exp 09/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 2, 2010.
Manufacturer: Pharmachemie B.V., Haarlem, Netherlands. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Some vials may not meet the visible particle specification.
VOLUME OF PRODUCT IN COMMERCE
7,910 vials
DISTRIBUTION
AL, AZ, CA, FL, HI, KY, MA, MI, MO, NC, OH, PA, TN, TX and VA
___________________________________
PRODUCT   
Nifedipine Extended-Release Tablets, USP, 60 mg, 100 count unit dose box (10 blister cards of 10 unit dose tablets), Rx only, NDC 0182-8233-89. Recall # D-449-2011
CODE
Lot # 0809T01A exp 6/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 11, 2010.
Manufacturer: Biovail International Corp., Mississauga Ontario, Canada. Firm initiated recall is complete.
REASON
Does Not Meet Sustained Release Specifications: Above specification dissolution results at 4 hours were found during 9 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
1153 cartons (each containing 100 tablets in blister packs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Clomed Capsules Dietary Supplement, 50 mg proprietary blend, 60 capsules/bottle. UPC 858515000967 & 858515002657. Recall # D-451-2011
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: KiloSports Inc., Phoenix, AZ, by telephone and press release on September 15, 2010.
Manufacturer: Watson Industries Inc., Pomona, CA. FDA initiated recall is ongoing.  
REASON
Marketed without an approved NDA/ANDA.
VOLUME OF PRODUCT IN COMMERCE
20,000 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT   
Fexofenadine Hydrochloride Tablets USP, 180 mg, 100 count bottle, Rx only; NDC 0093-7253-01. Recall # D-448-2011
CODE
Lot number 26F109
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 23, 2011.  
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
14,072 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
0.9% Sodium Chloride Injection, USP, latex free IV bags, a) 1000 mL (NDC 0409-7983-09), b) 1000 mL VisIV Container (NDC 0409-7983-48), Rx only. Recall #D-450-2011
CODE
Lot #: a) 90-070-JT*, Exp 11/01/12, *Note: the lot code number may be followed by 01, 02, 03, 04, 90, or 91; b) 90-035-JT**, Exp 06/01/12, **Note: the lot code number may be followed by 01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on March 4, 2011 and March 23, 2011.  
Manufacturer: Hospira, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The product is being recalled due to defective containers. The bags containing the 0.9% Sodium Chloride Injection, USP solution has the potential to leak. Leaking bags have the potential to result in contamination.
VOLUME OF PRODUCT IN COMMERCE
518,376 bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Nabumetone Tablets USP, 750 mg, 100 count bottle, Rx only; NDC 0093-1016-01. Recall # D-454-2011
CODE
Lot # 05N243
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 23, 2011
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
8,085 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Lansoprazole Delayed-Release Capsules USP, 30 mg, 30-count bottle, Rx only; NDC 0093-7351-56. Recall #D-458-2011
CODE
Lot # 44L007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 23, 2011.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
74,521 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT   
1) Pjur med CLEAN, personal cleaning spray lotion, alcohol free, perfume free, Made in Germany, e100 ml 3.4 fl. oz. Recall # D-446-2011;
 
2) Pjur med CLEAN, personal soft cleaning fleece, alcohol free, parfume free, 25 soft cleaning fleece, Made in Germany. Recall # D-447-2011
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pjur Group USA, Miami Beach, FL, by letter dated February 22, 2011.
Manufacturer: Dr. Schumacher, Melsungen, De, Germany. FDA initiated recall is ongoing.
REASON
Misbranded-Labeling Bears Unapproved Their Claims: The product labeling contains drug claims which make these products unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
640 Packets Fleece; 4404 Bottle Spray
DISTRIBUTION
Nationwide and Canada

 

 

___________________________________
PRODUCT   
Pulmolite, Kit for the Preparation of Technetium Tc 99m Albumin Aggregated for Injection, 30 vial kit, Rx only, NDC 45567-0415-2. Recall # D-452-2011
CODE
Lot 160041 Exp. July 31, 2011
RECALLING FIRM/MANUFACTURER
Pharmalucence, Inc., Bedford, MA, by letter on February 24, 2011. Firm initiated recall is ongoing.
REASON
Product Lacks Stability: Stability test data for particle size at 12-months found one particle >150um does not meet specification.
VOLUME OF PRODUCT IN COMMERCE
385/30 vial kits
DISTRIBUTION
Nationwide, Australia
___________________________________
PRODUCT   
Metformin Hydrochloride Tablets 1000 mg, 60 count bottles, NDC 0781-5052-61. Recall # D-453-2011
CODE
Lot number: BJ0003
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letter on February 24, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets; Metformin HCl 500mg tablets may have been packaged with Metformin HCl 1000mg tablets.
VOLUME OF PRODUCT IN COMMERCE
17,784 / 60 count bottles
DISTRIBUTION
IN
___________________________________
PRODUCT   
1) Glyburide Tablets, USP, 1.25 mg, 100 count bottle, Rx only, NDC 0781-1138-01. Recall # D-455-2011;
 
2) Glyburide Tablets, USP, 2.5 mg, 100 count bottle, Rx only; NDC 0781-1146-01.  Recall # D-456-2011;
 
3) Glyburide Tablets, USP, 5 mg Rx only, 1) 100 count bottle, NDC 0781-1191-01; 2) 1000 count bottle, NDC 0781-1191-10. Recall#D-457-2011
CODE
1) Lot number: 100724, Exp date: 04/11; Lot number: 101238, Exp date: 05/11; Lot number: 102102, Exp date: 08/11; Lot number: 102684, Exp date: 10/11;
 
2) Lot Number: 100275, Exp. date: 02/12; Lot Number: 100277, Exp. date: 02/12; Lot Number: 100607, Exp. date: 04/12; Lot Number: 100629, Exp. date: 04/12; Lot Number: 100976, Exp. date: 05/12; Lot Number: 100977, Exp. date: 05/12; Lot Number: 100994, Exp. date: 05/12; Lot Number: 101042, Exp. date: 05/12; Lot Number: 101044, Exp. date: 05/12; Lot Number: 101631, Exp. date: 07/12; Lot Number: 101851, Exp. date: 07/12; Lot Number: 101852, Exp. date: 07/12; Lot Number: 102240, Exp. date: 09/12; Lot Number: 102241, Exp. date: 09/12; Lot Number: 102686, Exp. date: 10/12;
 
3) 1) Lot number: 100351, Exp. date: 03/12; Lot number: 100352, Exp. date: 03/12; Lot number: 100595, Exp. date: 03/12; Lot number: 100596. Exp. date: 04/12; Lot number: 100813, Exp. date: 04/12; Lot number: 100814, Exp. date: 04/12; Lot number: 101072, Exp. date: 05/12; Lot number: 101073, Exp. date: 05/12; Lot number: 101811, Exp. date: 07/12; Lot number: 102231, Exp. date: 09/12; Lot number: 102333, Exp. date: 09/12;
2) Lot number: 100349, Exp. date: 03/12; Lot number: 100350, Exp. date: 03/12; Lot number: 100356, Exp. date: 03/12; Lot number: 100389, Exp. date: 03/12; Lot number: 100390, Exp. date: 03/12; Lot number: 100399, Exp. date: 03/12; Lot number: 100537, Exp. date: 03/12; Lot number: 100545, Exp. date: 03/12; Lot number: 100546, Exp. date: 03/12; Lot number: 100547, Exp. date: 03/12; Lot number: 100572, Exp. date: 03/12; Lot number: 100592, Exp. date: 03/12; Lot number: 100593, Exp. date: 03/12; Lot number: 100594, Exp. date: 03/12; Lot number: 100811, Exp. date: 04/12; Lot number: 100812, Exp. date: 04/12; Lot number: 100815, Exp. date: 04/12; Lot number: 100816, Exp. date: 04/12; Lot number: 100817, Exp. date: 04/12; Lot number: 100818, Exp. date: 04/12; Lot number: 100819, Exp. date: 04/12; Lot number: 100820, Exp. date: 04/12; Lot number: 100821, Exp. date: 04/12; Lot number: 101045, Exp. date: 05/12; Lot number: 101046, Exp. date: 05/12; Lot number: 101047, Exp. date: 05/12; Lot number: 101048. Exp. date: 05/12; Lot number: 101074, Exp. date: 05/12; Lot number: 101075, Exp. date: 05/12; Lot number: 101076, Exp. date: 05/12; Lot number: 101077, Exp. date: 05/12; Lot number: 101083, Exp. date: 05/12; Lot number: 101084, Exp. date: 05/12; Lot number: 101085, Exp. date: 05/12; Lot number: 101086, Exp. date: 05/12; Lot number: 101087, Exp. date: 05/12; Lot number: 101088, Exp. date: 05/12; Lot number: 101504, Exp. date: 06/12; Lot number: 101505, Exp. date: 06/12; Lot number: 101506, Exp. date: 06/12; Lot number: 101507, Exp. date: 06/12; Lot number: 101508, Exp. date: 06/12; Lot number: 101509, Exp. date: 06/12; Lot number: 101779, Exp. date: 07/12; Lot number: 101780, Exp. date: 07/12; Lot number: 101803, Exp. date: 07/12; Lot number: 101804, Exp. date: 07/12; Lot number: 101805, Exp. date: 07/12; Lot number: 101806, Exp. date: 07/12; Lot number: 101807, Exp. date: 07/12; Lot number: 101808, Exp. date: 07/12; Lot number: 101809, Exp. date: 07/12; Lot number: 101810, Exp. date: 07/12; Lot number: 102047, Exp. date: 08/12; Lot number: 102048, Exp. date: 08/12; Lot number: 102049, Exp. date: 08/12; Lot number: 102050, Exp. date: 08/12; Lot number: 102078, Exp. date: 08/12; Lot number: 102079, Exp. date: 08/12; Lot number: 102080, Exp. date: 08/12; Lot number: 102081, Exp. date: 08/12; Lot number: 102092, Exp. date: 08/12; Lot number: 102094, Exp. date: 08/12; Lot number: 102095, Exp. date: 08/12; Lot number: 102096, Exp. date: 08/12; Lot number: 102097, Exp. date: 09/12; Lot number: 102098, Exp. date: 09/12; Lot number: 102099, Exp. date: 09/12; Lot number: 102100, Exp. date: 09/12; Lot number: 102101, Exp. date: 09/12; Lot number: 102334, Exp. date: 09/12; Lot number: 102335, Exp. date: 09/12; Lot number: 102390, Exp. date: 10/12; Lot number: 102391, Exp. date: 10/12; Lot number: 102392, Exp. date: 09/12; Lot number: 102393, Exp. date: 09/12; Lot number: 102394, Exp. date: 10/12; Lot number: 102395, Exp. date: 10/12; Lot number: 102715, Exp. date: 11/12; Lot number: 102716, Exp. date: 11/12; Lot number: 102717, Exp. date: 11/12 Lot number: 102718, Exp. date: 11/12; Lot number: 102720, Exp. date: 11/12; Lot number: 102721, Exp. date: 11/12; Lot number: 102722, Exp. date: 11/12
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letter on March 24, 22011. Firm initiated recall is ongoing.  
REASON
Labeling: Incorrect or Missing Package Insert: Product is packaged with an obsolete version of the package insert (outsert).
VOLUME OF PRODUCT IN COMMERCE
720,647 bottles
DISTRIBUTION
CO
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0851-11
CODE
Units: 2117969; 2117779; 2117779
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated June 13, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Advil, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1233-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1234-11
CODE
1) Units: 12FY30253, 12FY30254, 12FY30255, 12FY30256, 12FY30258, 12FY30259, 12FY30260, 12FY30261, 12FY30263, 12FY30264, 12FY30265, 12FY30266, 12FY30267, 12FY30268, 12FY30269, 12FY30270, 12FY30271, 12FY30272 12FY30273, 12FY30274, 12FY30275, 12FY30276, 12FY30277, 12FY30278, 12FY30279, 12FY30280, 12FY30281, 12FY30282;
 
2) Units: 12FY30253, 12FY30254, 12FY30256, 12FY30258, 12FY30261, 12FY30263, 12FY30270, 12FY30271, 12FY30272, 12FY30276, 12FY30280
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by letter dated December 12, 2008.
Manufacturer: American Red Cross Blood Services, Cary, NC. Firm initiated recall is complete
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
NC
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1247-11
CODE
Unit: W038111004033
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL, by telephone on February 11, 2011. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1248-11;
2) Recovered Plasma. Recall # B-1249-11;
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1250-11
CODE
1) and 2) Unit: W117010108710;
3) Units: W117010187555; W117010187555
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone and fax on March 2, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1251-11
CODE
Unit: 5176007
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone on April 19, 2006.  
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malaria and leishmaniasis endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1252-11
CODE
Units: 7250127 Part 1 ;7250127 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone on August 16, 2007. 
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium Acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. B-1253-11
CODE
Unit: 012GC21818
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who tested repeat reactive for Chagas Disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1255-11
CODE
Unit: LE96854
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 17, 2005. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1257-11
CODE
Units: 0490676072, 0490675564, 0490674498, 0490673944, 0490672943, 0490672432, 0490671363, 0490670838, 0490669852, 0490668373, 0490662657, 0490661979, 0490661215, 0490660503, 0490659757
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Grand Prairie, TX, by electronic mail on September 22, 2008. 
Manufacturer: CSL Plasma, Inc., Grand Prairie, TX. Firm initiated recall is complete.
REASON
Blood products, in which donor screening/donor record were incomplete or incorrect, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Switzerland and Germany
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1265-11
CODE
Unit: W127811300216
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on February 23, 2011 and by letter dated February 23, 2011. Firm initiated recall is complete.
REASON
Blood product, for which the sterility may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1266-11
CODE
Unit: W037710059530
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letters dated January 25, 2011 and March 18, 2011. 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
OH

 

 

___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1267-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1268-11;
3) Platelets Leukocytes Reduced. Recall # B-1269-11
CODE
1), 2) and 3) Unit: 032KL22445
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone on December 14, 2006 and by facsimile on December 15, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI, IL
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1232-11
CODE
Unit: 7325356
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York New, NY, by telephone on June 14, 2007 and by facsimile on June 20, 2007.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1254-11
CODE
Units: FM47151 Part 1; FM47151 Part 2
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on March 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using an expired collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma.Recall # B-1256-11
CODE
Unit: 007GE46765
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, via the LOGIC system on February 16, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Ellex Super Q LQP3106 ophthalmic laser. Recall # Z-1840-2011;
2) Ellex Ultra Q LQP3106-U ophthalmic laser. Recall # Z-1841-2011;
3) Alcon 3000LE ophthalmic laser. Recall # Z-1842-2011;
4) Ellex Tango LT5106-T ophthalmic laser (not sold in USA). Recall # Z-1843-2011;
5) Ellex Solo LT5106-S ophthalmic laser (not sold in USA). Recall # Z-1844-2011
CODE
All units manufactured before 20 February 2011
RECALLING FIRM/MANUFACTURER
Ellex Medical Pty Ltd, Adelaide, Australia, by Service Bulletin dated 25 February 2011. Firm initiated recall is ongoing.
REASON
Unintended laser emission while the user was moving the joystick for targeting.
VOLUME OF PRODUCT IN COMMERCE
2,335 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011
CODE
All units with Version 3.20 software.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter dated March 14, 2011.
Manufacturer: Gambro Lundia Ab - Disposables Division, Lund, Sweden. FDA initiated recall is ongoing.
REASON
Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.
VOLUME OF PRODUCT IN COMMERCE
1,300 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water. Recall # Z-1960-2011
CODE
All codes manufactured from 5/5/2010 through 3/8/2011.
RECALLING FIRM/MANUFACTURER
Steris Corporation Hopkins Facility, Mentor, OH, by letter dated March 14, 2011. FDA initiated recall is ongoing.
REASON
The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to incomplete processing.
VOLUME OF PRODUCT IN COMMERCE
106 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1962-2011;
 
2) ExactaMix EVA Container, 250mL, REF: 737, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1963-2011
 
3) ExactaMix EVA Container, 500mL, REF: 738, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1964-2011;
 
4) ExactaMix EVA Container, 1000mL, REF: 739, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1965-2011;
 
5) ExactaMix EVA Container, 2000mL, REF: 740, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1966-2011;
 
6) ExactaMix EVA Container, 3000mL, REF: 741, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1967-2011
CODE
All codes sold since 7/23/2009.
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated March 8, 2011. Firm initiated recall is ongoing.
REASON
TPN bags may leak during filling operation, due to bag manufacturing error.
VOLUME OF PRODUCT IN COMMERCE
6,831,000 bags
DISTRIBUTION
Nationwide, and Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela
___________________________________
PRODUCT
UniCel DxC Clinical Systems with UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102 Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP. Recall # Z-1972-2011
CODE
Serial Number less than 3412 (labeled behind the lower right side instrument door).
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter dated November 16, 2010. Firm initiated recall is ongoing.  
REASON
The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.
VOLUME OF PRODUCT IN COMMERCE
1,535 units
DISTRIBUTION
Nationwide, Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom
___________________________________
PRODUCT   
1) UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1977-2011;
 
2) UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1978-2011
CODE
All serial numbers, SW version 1.1.3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for populations with small volume specimen draws such as newborns.
VOLUME OF PRODUCT IN COMMERCE
422 units
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
___________________________________
PRODUCT   
Coulter AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356. The Coulter ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial). Recall # Z-1979-2011
CODE
All Serial Numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated February 23, 2011.
Manufacturer: Horiba ABX SAS, Montpellier, France. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment, or the delivery of temporarily ineffective treatment, due to HCT 4.0 - 9.8% misleading effects on diagnoses for anemia, internal bleeding, Polycythemia Vera or dehydration; (2) False high PLT may cause permanent damage to patients with critically low PLT who require immediate corrective or prophylactic platelet transfusion; (3) A false high MPV is unlikely to affect immediate clinical assessment of a patient.
VOLUME OF PRODUCT IN COMMERCE
1,211 units
DISTRIBUTION
Nationwide, Angola Mexico, Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Tanzania, and Turkey
___________________________________
PRODUCT
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1980-2011
CODE
All serial numbers, SW version 1.1.3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.
VOLUME OF PRODUCT IN COMMERCE
422 units total (175 in US)
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
___________________________________
PRODUCT
Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided. Recall # Z-1983-2011.
CODE
All serial numbers manufactured prior to February 1, 2011.
RECALLING FIRM/MANUFACTURER
Arjo, Inc. dba ArjoHuntleigh, Addison, IL, byletter dated March 4, 2011.
Manufacturer: B.h.m. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.
REASON
The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.
VOLUME OF PRODUCT IN COMMERCE
1,246 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution, Femoral and Provisional Impactor/Extractor, REF 00-5901-026-00. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1985-2011;
 
2) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer, REF 00-5901-040-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1986-2011;
 
3) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer Boom, REF 00-5901-040-10, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1987-2011;
 
4) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Peg Drill Guide Handle, REF 00-5903-060-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1988-2011;
 
5) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Quick-Connect Handle, REF 00-5901-034-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1989-2011;
 
6) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Modular T-Handle, REF 00-5901-061-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1990-2011;
 
7) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Distal Telescoping Tube, REF 00-5901-071-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1991-2011;
 
8) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Proximal Telescping Rod, REF 00-5901-072-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1992-2011
 
9) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Modular Spike Arm Post, REF 00-5901-074-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1993-2011;
 
10) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Distal Femoral Resection Guide, REF 00-5901-063-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1994-2011;
 
11) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Femoral Valgus Alignment Guide, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1995-2011;
 
12) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Clamp, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1996-2011;
 
13) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Osteotomy Guide, REF 00-5903-010-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1997-2011
CODE
1) Lots: 61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596, 61675231, 61691488, 61701224 and 61708918;
 
2) Lots: 61510769, 61558673, 61584439, 61584919 and 61610687;
 
3) Lots: 61505400, 61558201, 61570225, 61574608, 61580669, 61585371 and 61594877;
 
4) Lots: 61511575, 61532582, 61539020, 61542246, 61554844, 61580690, 61610344, 61630733 and 61509149;
 
5) Lots: 61501824, 61542065, 61550601, 61575890, 61585376, 61612789, 61615894, 61626378, 61634995, 61635431, 61648520, 61657310, 61660292, 61675232 and 61682485;
 
6) Lots: 61491168, 61517185, 61580671, 61609572, 61635436, 61655095 and 61658440;
 
7) Lots: 61515856, 61559187, 61581693, 61582497, 61593950, 61610647, 61633778, 61635523, 61637140 and 61659209;
 
8) Lots: 61495957, 61543636, 61583135 and 61586295;
 
9) Lots: 61488062, 61549223, 61584526, 61593951, 61516298 and 61517186;
 
10) Lots: 61511564, 61548704, 61583731, 61586294, 61608148, 61610172, 61615895, 61632405, 61635449, 61658442, and 61673283;
 
11) Lots: 61516151, 61517153, 61559529, 61585375, 61587424, 61603824, 61610584, 61610623, 61625078, 61628952, 61635427, 61635428, 61655097 and 61658448;
 
12) Lots: 61516147, 61554517, 61555948, 61587399, 61610586, 61635432, 61652932 and 61658455;
 
13) Lots: 61510164 and 61559367
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated March 14, 2011. Firm initiated recall is ongoing.  
REASON
The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
VOLUME OF PRODUCT IN COMMERCE
6,026 units
DISTRIBUTION
Nationwide, Australia, Canada, Germany, Japan, New Delphi and Singapore
___________________________________
PRODUCT
GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; list 13092-04-01. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Recall # Z-1999-2011
CODE
Lot numbers: 71-494-G1, 72-613-G1 and 84-832-G1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, letters dated March 23, 2011.
Manufacturer: Hospira Inc., Morgan Hill, CA. Firm initiated recall is ongoing.
REASON
The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.
VOLUME OF PRODUCT IN COMMERCE
139 units
DISTRIBUTION
Nationwide, Canada, Chile, Colombia and Singapore

 

 

___________________________________
PRODUCT
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Recall #Z-2059-2011
CODE
Serial numbers: P16C080002, P16E080005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E090006, P16E090007, P16E090009, P16E090012, P16E090003, P16E090010, P16E090011, P16E090013, P16EM09003, P16EM09004, P16E090002, P16E090014, P16E090015, P16EM08003, P16E090016, P16E090018, P16E090019, P16E090020, P16E090021, P16E090026, EP16E090001, P16E090028, P16E090027, P16E090017, P16EM09002, P16E090024, P16E090025, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, P16C090001, EP16E090010, EP16E090011, EP16E090012, EP16E090014, EP16E090015, EP16E100001, EP16E100002, EP16E100004, EP16E100003, EP16E100005, EP16E100006, EP16E100007, EP16E090013, EP16E100008, EP16E100009, EP16E100010, P16C100001, EP16E100011, EP16E100012, EP16E100013, EP16E100014, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, P16C080001, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100027, EP16E100026, EP16E100030, EP16E100031, EP16E100029, P16C100003, EP16E100025, EP16E100028, P16C100002, EP16E100034, EP16E100033, EP16E100032, EP16E100035, EP16E100036, EP16E100037, P16E100002, P16C100004, EP16E100039, EP16E100038, EP16E100042, EP16E100043, EP16E100041, EP16E100044, EP16E100046, EP16E100045, EP16E100048, EP16E100047, EP16E100051, EP16E100049, EP16E100050, EP16E100053, EP16E100052, EP16E100054, EP16E100056, EP16E100055, P16C100005, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, P16C100007, EP16E100067, EP16ER100003, EP16ER100004, EP16ER100005, EP16E100070, EP16E100069, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100078, EP16E100075, EP16E100076, EP16E100077, EP16E100079, EP16E100080, EP16E100082, EP16E100081, EP16E100083, EP16E100084, P16C100008, P16C100009, EP16E100085, EP16E100086, EP16E100087, P16C100010, EP16E100088, EP16E100089, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100092, P16C100014, P16C100015, EP16E100095, P16C100011, EP16E100096, EP16E100097, EP16E100098, P16C100017, EP16E100099, EP16E100100, EP16E100101, EP16E100102, P16C100013, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100109, EP16E100107, P16C100012, EP16E100108, EP16E100111, EP16E100110, P16C100018, EP16E100112, EP16ER100008, EP16ER100007, EP16E100113, EP16E110003, EP16E110001, EP16E110002, EP16E110004, and EP16E110005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 10, 2011.
Manufacturer: Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China. Firm initiated recall is ongoing.
REASON
The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inaccurate dimension information to patients, which could result in misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
168 units
DISTRIBUTION
AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC, TX, Puerto , Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, Japan, Kenya
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Family Farm Complete Horse 10, 10% Pelleted Feed, packaged in 40-lb. bags, nonmedicated feed. Recall # V-125-2011
CODE
Bag tag - 1006; White strip sewn across bottom of bag - MADE 010611W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Manna Pro Corp., Chesterfield, MO, by telephone, e-mail and visit on January 21, 2011 and by press release on January 28, 2011.  
Manufacturer: Western Milling LLC, Goshen, CA. Firm initiated recall is on complete.
REASON
Some of the horse feed bags contain monensin.
VOLUME OF PRODUCT IN COMMERCE
513/40-lb.bags
DISTRIBUTION
CA, NV, OR
 
END OF ENFORCEMENT REPORT FOR MAY 4, 2011
 

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