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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 23, 2012

 

May 23, 2012                                                                                           12-21
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT
1) Catfish Carl's Realistic Washes, 0.30-proof Tattoo Wash, 2-oz. and 4-oz. bottles, Hand-blended Lite Wash Pigment. The product is in plastic squeeze bottle with turn nozzle on top. Recall # F-1256-2012;
 
2) Catfish Carl's Realistic Washes, 0.60-proof Tattoo Wash, 2-oz. and 4-oz. bottles, Hand-blended Medium Wash Pigment. The product is in plastic squeeze bottle with turn nozzle on top. Recall # F-1257-2012;
 
3) Catfish Carl's Realistic Washes, 0.90-proof Tattoo Wash, 2-oz. and 4-oz. bottles, Hand blended Dark Wash Pigment. The product is in plastic squeeze bottle with turn nozzle on top. F-1258-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
4 Forty 4 Tattoo, Tucson, AZ, by telephone and email beginning April 25, 2012. FDA initiated recall is ongoing.
REASON                                                                                                                                                 
The product is potentially contaminated with Mycobacterium chelonae
VOLUME OF PRODUCT IN COMMERCE
62 sets (3 per set)
DISTRIBUTION
NV, AZ
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
HUIPU brand CHINESE WOLFBERRY, NET WT: 150 G (5.28oz) -- UPC 6 922601 399892 -- PRODUCT OF CHINA --- Nutrition Facts: Serving Size 30g, Servings per container 5. --- The product is packed in a sealed, plastic package (bag). Recall # F-1237-2012
CODE
UPC and no other coding
RECALLING FIRM/MANUFACTURER
Strong America Limited, Long Island City, NY, by press release and letters dated September 14, 2011. New York Initiated recall is complete.
REASON                                                                                                                                                
The product was found to contain undeclared sulfites (850.7 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Mastiha shop --- Pie with Chios Mastiha --- Ingredients: Sugar, Corn Syrup, Albumen, Waffle, Almonds 12%, Chios Mastiha 0.1%, Mastiha oil. Recall # F-1238-2012;
 
2) Mastiha shop --- Halva Pie with Chios Mastiha and Peanuts --- Ingredients: Sugar, Corn Syrup, Albumen, Waffle, Peanuts 12%, Chios Mastiha 0.1%, Mastiha oil. Recall # F-1240-2012;
 
3) Mastiha shop --- Honey Pie with Almonds --- Ingredients: Sugar, Corn Syrup, Honey 5%, Almonds 12%, albumen, waffle. Recall # F-1241-2012;
 
4) Mastiha shop --- Handmade "Trahana" Pasta with Mastiha --- Ingredients: wheat flour, semoline, yogurt, tomato, onion, olive oil, chios mastiha 1.8%, salt. Recall # F-1242-2012
CODE
1) LOT09120202 and best before end 12/30/2012;
2) LOT85111104 and best before end 06/25/2012;
3) LOT27111107 and best before end 06/30/20;
4) LOT03101125 and best before end 04/30/2012
RECALLING FIRM/MANUFACTURER
Mediterra SA, Khios, Greece, by telephone and e-mail on March 28, 2012 and by press release on April 12, 2012. FDA initiated recall is complete.
REASON                                                                                                                                                 
Mediterra SA has recalled pies because "albumen" is not declared as "egg albumen"; Mediterra SA has recalled Trahana pasta because "yogurt" is not declared as "milk yogurt"
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT
GourMates Tartar Sauce Pouch 200/12g, UPC Code: 00802073701309, Item # 85667. Recall # F-1243-2012
CODE
Lot numbers: MP3131B, MP3532B, MP0241C, MP0311C, MP0442C, MP0513C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamond Crystal Brands, Inc., Savannah, GA, by telephone on April 23, 2012 and follow-up letter on April 24, 2012.
Manufacturer: Diamond Crystal Brands Inc., Bremen, GA. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Product contains undeclared allergens, milk and egg.
VOLUME OF PRODUCT IN COMMERCE
1298 cases (200/12g units per case)
DISTRIBUTION
AL, CA, GA, IL, MO, NJ and WA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Snack mix in a plastic bag, labeled in part: a) Powers SNACK TIME HIGH ENERGY SNACKS Bandito Snack Mix Combinacion de Bocado Bandito Net. Wt. 7.5 oz (213g)*** UPC: 041373016090; Ingredients: Peanuts roasted in Vegetable Oil (Sunflower), Enriched Wheat Flour (Unbleached Wheat,Barley, Corn,Potato, Bulgar Wheat, Tomato, Niacin, Reduced Iron, Thiamine, Mononitrate, Riboflavin, Folic Acid, Citric Acid), Sesame Seeds, Beet Powder, Salt, Maltodextrin, Malt, Natural Flavor (Garlic, Onion, Green Bell Pepper, Spices, Cocoa), Paprika, Yeast, Baking Soda, Monosodium Glutamate, Tumeric.***Best By Date***ALLERGY ALERT: Product is stored in a facility and processed on equipment that also processes Peanuts, Tree Nuts (Almonds, Pecans, Walnuts), Soybeans, and Milk***" There is also a second size: b) "Net. Wt. 28 oz. (1.75 lbs.) 794 g", UPC: 041373012429, Recall # F-1233-2012
CODE
a) 11 APR 2012*DB, 31 MAY 2012*JK, 01 JUN 2012*JK, 03 AUG 2012*JK, 04 AUG 2012*JK, 07SEP2012*JK, 02 NOV 2012*JK, 09 FEB 2013*PC;
b) 07 PAR 2012*DB, 08 PAR 2012*DB, 31 MAY 2012*JK, 01 JUN 2012*JK, 02 JUN 2012*JK, 02 AUG 2012*DB, 03 AUG 2012*DB, 07 SEP 2012*JK, 01 NOV 2012 * JK, 14 DEC 2012*JK, 07 FEB 2013*JK
RECALLING FIRM/MANUFACTURER
Powers Candy & Nut Co., Spokane, WA, by e-mail, telephone or visit beginning April 2, 2012. Washington initiated recall is ongoing.
REASON
Soy oil was not declared on the finished product label.
VOLUME OF PRODUCT IN COMMERCE
7.5 oz-7331 caes, 6 bags per case & 28 oz-5132 cases, 6 bags per case
DISTRIBUTION
Unknown
___________________________________
PRODUCT
1) Old Fashioned Foods , Jalapeno Cheese Snack Spread, Net Wt 8 oz (227g)., Ingredients: water, partially hydrogenated soybean oil, modified food starch, salt, less than 2% sodium phosphate , lactic acid, jalapeno peppers, guar gum , sorbic acid (as a preservative), annatto color, cheese culture, pepper concentrate, enzymes, UPC 48707 44112. Recall # F-1234-2012;
2) Old Fashioned Foods, Pepper jack, Cheese Snack Spread, Net Wt 8 oz (227g).,Ingredients: water, whey, partially hydrogenated soybean oil, cheddar cheese, red bell peppers, modified food starch, jalapeno peppers, sodium phosphate, less than 2% salt, green bell peppers, lactic acid, guar gum , sorbic acid (as a preservative), pepper flavor, annatto color, UPC 48707 44111. Recall # F-1235-2012;
3) Old Fashioned Foods , Nacho, Cheese Snack Spread, Net Wt 8 oz (227g)., Ingredients: water, whey, partially hydrogenated soybean oil, cheddar cheese, modified food starch, red bell peppers, less than 2% sodium phosphate, salt, green bell peppers, , lactic acid, guar gum , jalapeno peppers, sorbic acid (as a preservative), nacho seasoning (chili peppers, spices, dehydrated onion, and garlic, paprika, natural flavor, malto dextrin), annatto color, UPC 48707 44118. Recall # F-1236-2012
CODE
1) Sell By 17 Apr2012, Sell By 02 May2012, Sell By 10 May2012, Sell By 18 May2012, Sell By 23 May2012, Sell By 03 Jun2012, Sell By 08 Jun2012, Sell By 16 Jun2012, Sell By 23 Jun2012, Sell By 27 Jun2012, Sell By 07 July 2012, Sell By 04 Aug 2012, Sell By 16 Aug 2012, Sell By 29 Aug 2012, Sell By 21 Sept 2012, Sell By 11 Oct 2012, Sell By 26 Oct 2012, Sell By 08 Nov 2012, Sell By 22 Nov 2012, Sell By 01 Dec 2012, Sell By 07 Dec 2012, Sell By 05 Jan 2012, Sell By 10 Jan 2013, Sell By 12 Jan 2013, Sell By 10 Feb 2013, , Sell By 22 Feb 2013, Sell By 27 Mar 2013, Sell By 04 Apr 2013, Sell By 11 Apr 2013;
 
2) Sell By 27 Apr2012, Sell By 10 May2012, Sell By 16 Jun2012, Sell By 23 Jun2012, Sell By 13 July 2012,Sell By 25 July2012, Sell By 16 Aug 2012, Sell By 27 Sept 2012, Sell By 11 Oct 2012, Sell By 13 Oct 2012, Sell By 05 Jan 2012, Sell By 10 Jan 2013, Sell By 12 Jan 2013, Sell By 10 Feb 2013, , Sell By 29 Feb 2013, Sell By 17 Mar 2013, Sell By 11 Apr 2013;
 
3) Sell By 27 Apr 2012, Sell By 03 Jun 2012, Sell By 16 Jun 2012, Sell By 23 Jun 2012, Sell By 27 Jun 2012, Sell By 25 July 2012, Sell By 04 Aug 2012, Sell By 09 Aug 2012, Sell By 08 Sept 2012, Sell By 19 Oct 2012, Sell By 26 Oct 2012, Sell By 28 Nov 2012, Sell By 21 Dec 2012, Sell By 12 Jan 2013, Sell By 31 Jan 2013, Sell By 08 Mar 2013
RECALLING FIRM/MANUFACTURER
Old Fashioned Foods, Inc., Mayville, WI, by letter dated April 23, 2012. FDA initiated recall is ongoing.
REASON
Recall due to incorrect ingredient statements where milk has been inadvertently omitted.
VOLUME OF PRODUCT IN COMMERCE
36,405 cases (12/case)
DISTRIBUTION
AR, CA, IL, IA, KY, MA, MI, MN, NE, NV, NY, NC, ND, OH, SD, TN, TX, WI
___________________________________
PRODUCT
Mastiha shop --- Greek Garlic Spread with Almond --- Ingredients: Water, bread (32%), extra virgin olive oil (12%), almond (5%), vinegar, garlic, salt. Recall # F-1239-2012
CODE
LOT03110916 and best before end 09/30/2012
RECALLING FIRM/MANUFACTURER
Mediterra SA, Khios, Greece, by telephone and e-mail on March 28, 2012 and by press release on April 12, 2012. FDA initiated recall is complete.
REASON                                                                                                                                                 
Mediterra SA has recalled garlic spread due to undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT
Queso de Mano (Cheese), 24 oz. in a plastic package containing 24, 1-oz servings. Product is labeled in part: "***Queso de Mano***Soft Cheese***very low sodium - Trans Fat Free*** Fresh from Florida*** UniQueso***net wt. 24 oz (680g) - keep refrigerated*** Queso de Mano***Soft Cheese - 24 oz.*** VERY LOW SODIUM - TRANS FAT FREE***Nutrition Facts*** Serving Size: 1 oz (28g)***Servings per package: 24***INGREDIENTS: MILK, CULTURED SKIM MILK, SALT, RENNET.***ALL NATURAL, PASTURIZED PRODUCT***latitudefoods***long on life! ***Bar Code***1 80294 00001 3 ***". Recall # F-1244-2012
CODE
Product Code 1 80294 00001 3, distributed between 4/20/2011 to 4/21/2011.
RECALLING FIRM/MANUFACTURER
Latitude Foods, LLC, Orlando, FL, by telephone on April 19, 2011. Firm initiatd recall is ongoing.
REASON
Latitude Foods, LLC initiated a recall of their product Queso de Mano, Soft Cheese for the mix up of the serving size that claimed to be 8, 1-oz. servings for the nutritional facts, when in fact there was 24, 1-oz. servings in the package.
VOLUME OF PRODUCT IN COMMERCE
 54 units
DISTRIBUTION
FL
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Wegmans --- White Pita Bread --- UPC 077890113639 --- Packaged in plastic overwrap. Recall # F-1226-2012;
 
2) Wegmans --- White Mini Pita Bread --- UPC 077890171271 --- Packaged in plastic overwrap. Recall # F-1227-201;
 
3) Wegmans --- Food You Feel Good About --- 100% Whole Wheat Mini Pita Bread --- 100% Whole Wheat --- UPC 077890171301 --- Packaged in plastic overwrap. Recall # F-1228-2012;
 
4) Wegmans --- Food You Feel Good About --- Multi Grain Mini Pita Bread --- 100% Whole Grain --- UPC 077890183281--- Packaged in plastic overwrap. Recall # F-1229-2012;
 
5) Wegmans --- Food You Feel Good About --- Thin Sandwich Rolls --- Multigrain Whole Grain --- Net Wt 12 OZ (340g) --- UPC 077890258873 --- Packaged in plastic overwrap. Recall #F-1230-2012;
 
6) Wegmans --- Food You Feel Good About --- Thin Sandwich Rolls --- White made with Whole Grain --- Net Wt 12 OZ (340g) --- UPC 077890258880. Product is packaged in plastic overwrap. Recall # F-1231-2012;
 
7) Wegmans --- Food You Feel Good About --- Thin Sandwich Rolls --- 100% Whole Wheat --- Net Wt 12 OZ (340g) --- UPC 077890258910. Product is packaged in plastic overbag. Recall # F-1232-2012
CODE
1) 2) 3) 4)Best By 4/3/12;
5 – 7)Best By 4/5/12
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by email beginning March 29, 2012. Firm initiated recall is complete.
REASON
Product may contain a foreign object.
VOLUME OF PRODUCT IN COMMERCE
4,342 units
DISTRIBUTION
NY, PA, NJ, VA, MD, and MA
___________________________________
PRODUCT
1) Nature's Nectar 100% Apple Juice from Concentrate with Added Ingredient, No Added Sweetener, packaged in 64-fl. oz. containers. Recall # F-1245-2012;
 
2) Nature's Nectar Cranberry Apple, Flavored Juice Cocktail Blended with Another Juice from Concentrate, No High Fructose Corn Syrup, packaged in 64-fl. oz. containers. Note: This product is distributed in a mixed case containing Nature's Nectar Cranberry Grape and Nature's Nectar Cranberry Apple. Only the Cranberry Apple juice is subject to the recall. Recall # F-1246-2012;
 
3) Mrs.Clark's Authentic 100% Apple Juice, from concentrate, No Added Sugar, Sweeteners, or Preservatives, packaged in 64-fl. oz. containers. Recall # F-1247-2012;
 
4) Hormel Thick & Easy Thickened Apple Juice, 100% Apple Juice from Concentrate with Added Ingredients, for Swallowing Difficulty, Nectar Consistency, packaged in 48-fl. oz. containers. Recall # F-1248-2012;
 
5) Hormel Thick & Easy Thickened Apple Juice, 100% Apple Juice from Concentrate with Added Ingredients, for Swallowing Difficulty, Honey Consistency, packaged in 48-fl. oz. containers. Recall # F-1249-2012;
 
6) Hormel FiberBasics Apple Juice with Fiber, From Concentrate, Contains 100% Juice with Added Ingredients, for Digestive Health, packaged in 48-fl. oz. containers. Recall # F-1250-2012;
 
7) Mrs.Clark's Authentic Cranberry Raspberry, juice cocktail from Concentrate, No Artificial Sweeteners or Flavors, Vitamin C Enhanced, packaged in 64-fl. oz. Recall # F-1251-2012
 
8) Nature's Nectar 100% Juice, Fruit Punch, flavored blend of 3 juices from concentrate with added ingredients, packaged in 64-fl. oz. Note: This product is distributed in a mixed case containing 2 bottles each of Nature's Nectar Fruit Punch, Nature's Nectar Berry Burst, and Natures' Nectar Cherry. ALL three are being recalled. Recall # F-1252-2012;
 
9) Nature's Nectar Cranberry Raspberry, Flavored Juice Cocktail Blended with Another Juice from Concentrate, No High Fructose Corn Syrup, packaged in 64-fl. oz. Note: This product is distributed in a mixed case containing 3 bottles each of Nature's Nectar Cranberry Raspberry and Cranberry Pomegranate. Only the Cranberry Raspberry is subject to the recall. Recall # F-1253-2012;
 
10) Nature's Nectar 100% Juice, Berry Burst, flavored blend of 3 juices from concentrate with added ingredients, packaged in 64-fl. oz. Note: This product is distributed in a mixed case containing 2 bottles each of Nature's Nectar Fruit Punch, Nature's Nectar Berry Burst, and Natures' Nectar Cherry. ALL three are being recalled. Recall # F-1254-2012;
 
11) Nature's Nectar 100% Juice, Cherry, flavored blend of 4 juices from concentrate with added ingredients, packaged in 64-fl. oz. Note: This product is distributed in a mixed case containing 2 bottles each of Nature's Nectar Fruit Punch, Nature's Nectar Berry Burst, and Natures' Nectar Cherry. ALL three products are being recalled. Recall # F-1255-2012
CODE
1) Lot # 052413 MCF 00:00, Lot # 060613MCF 00:00, Lot # 061413MCF 00:00, Lot # 071213MCF 00:00, Lot # 070713MCF 00:00, Lot # 101013MCF 00:00, Lot # 102413MCF 00:00, and Lot # 110213MCF 00:00;
 
2) Case Label Codes: Lot # 053111, Lot # 061311, Lot # 062011, Lot # 071111, Lot # 072511, Lot # 081011, Lot # 090811, and Lot # 092011. Cranberry Apple Bottle Label Code: Lot # 052412 MCF 00:00, Lot # 060712MCF 00:00, and Lot # 081612MCF 00:00;
 
3) Lot # 23MAY2012;
 
4) Lot numbers M05311-1, M05311-2, M05311-3, M05311-4, M10181-1, M10181-2, M10181-3, and M10181-4;
 
5) Lot numbers M07121-1, M07121-2, M07121-3, and M07121-4;
 
6) Lot number M05311-1;
 
7) Lot number 23MAY2012;
 
8) Case Label Codes: Lot # 092110 and Lot # 111111. Fruit Punch Bottle Label Code: Lot # 0802112MCF 00:00, Lot # 082912MCF 00:00, Lot # 100512MCF 00:00, and Lot # 110812MCF 00:00;
 
9) Case Label Codes: Lot # 090811, Lot # 091411, Lot 3 092211, and Lot # 110311. Cranberry Raspberry Bottle Label Code: Lot # 0802112MCF 00:00, Lot # 082912MCF 00:00, and Lot # 100512MCF 00:00;
 
10) Case Label Codes: Lot # 092110 and Lot # 111111. Berry Blast Bottle Label Code: Lot #080212MCF 00:00, Lot # 082912MCF 00:00, Lot # 100512MCF 00:00, and Lot # 110812MCF 00:00;
 
11) Case Label Codes: Lot # 092110 and Lot # 111111. Cherry Bottle Label Code: Lot #080212MCF 00:00, Lot # 082912MCF 00:00, Lot # 100512MCF 00:00, Lot # 110812MCF 00:00
RECALLING FIRM/MANUFACTURER
Mrs Clark's Foods L.C., Ankeny, IA, via email, fax, and letters dated November 15, November 16, and November 23, 2011. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The 100% apple juice concentrate used to manufacture the finished products contains levels of isomaltose.
VOLUME OF PRODUCT IN COMMERCE
607,572 / 64-fl.oz bottles and 56,768 / 48-fl. oz. bottles
DISTRIBUTION
GA, IL, IA, and MN
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions toCDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
______________________________________
PRODUCT
 
None
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Celestone brand of betamethasone Oral Solution USP, 0.6 mg/ 5 mL, supplied in 4 fluid ounce (118 mL) amber glass bottles, Rx only, NDC 0085-0942-05. Recall # D-1354-2012
CODE
LOT 9 APR, 100 EXP MAR 12; LOT 9 APR 101, EXP AUG 12; LOT 9 APR 102, EXP SEP 12; LOT 9 APR 103, EXP NOV 12; LOT 0 APR 100, EXP MAR 13; LOT 0 APR 101, EXP JUN 13; LOT 0 APR 102, EXP SEP 13; LOT 0 APR 103, EXP SEP 13
RECALLING FIRM/MANUFACTURER
Merck, Inc., Kenilworth, NJ, by letters on January 23, 2012. Firm initiated recall is ongoing.
REASON
Failed Content Uniformity Requirements; potential for dosing variability found during routine product stability testing.
VOLUME OF PRODUCT IN COMMERCE
96,033 glass bottles
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1301-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1302-12
CODE
1) Units: 06KR43417, 06KT35734;
2) Unit: 06LX74493
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on November 29, 2005. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, for which the documentation of irradiation was discrepant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Whole Blood. Recall # B-1306-12;
2) Red Blood Cells. Recall # B-1307-12
CODE
1) Units: LY01822, LY01824, LY02042, LY02044;
 
2) Units: LJ30560, LJ30561, LJ55130, LJ55135, LJ75311, LJ75325, LJ84968, LK47532
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated November 2, 2005. Firm initiated recall is complete.
REASON
Blood products, for which the nucleic acid testing (NAT) for HIV/HCV was invalid, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1310-12
CODE
Unit: 9236743
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on March 21, 2008.
Manufacturer: North Bay Center, Fairfield, CA. 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
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1311-12;
2) Fresh Frozen Plasma. Recall # B-1312-12
CODE
1) and 2) Unit: W037709010389
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated April 16, 2009. 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
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1313-12
CODE
Unit: 2823286
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated December 13, 2006. 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
OH
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1314-12
CODE
Unit: W037709019760
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on April 14, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-1315-12
CODE
Units: 0460594682; 0460593230; 0460591912; 0460590292; 0460588840; 0460587150; 0460585042; 0460583344; 04605815110; 0460579509; 0460577674; 0460575936; 0460574107; 0460872091; 0460570106; 0460594292; 0460592795; 0460591349; 0460589797; 0460588313; 0460586767; 0460584499; 0460582672; 0460580622; 0460578890; 0460577161; 0460575062; 0460573146; 0460571133; 0460569081; 0460568039; 0460566207; 0460564115; 0460562036; 0460559583; 0460557074; 0460555043; 0460567160; 0460564733; 0460562733; 0460560241; 0460558278; 0460556385; 0460552981
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, via e-mail on November 9, 2009.
Manufacturer: CSL Plasma, Dallas, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1316-12
CODE
Unit: 084J98123
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated August 26, 2005. 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
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. B-1317-12;
2) Recovered Plasma. Recall # B-1318-12
CODE
1) and 2) Unit: W037708045416
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated February 26, 2009. 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
2 units
DISTRIBUTION
OH, IL
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1319-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1320-12
CODE
1) and 2) Units: 8747538, 5553097
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on October 29, 2007.
Manufacturer: Marin Center, San Rafael, CA. 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
CA, Switzerland and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1332-12
CODE
Unit: W141607612944
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated October 10, 2007. 
Manufacturer: Puget Sound Blood Center, Bellevue, WA. 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
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1333-12
CODE
Unit: V131010
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by electronic notification on September 24, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1334-12
CODE
Units: 16KQ01834 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on May 7, 2007 and by letter dated May 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1335-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1336-12
CODE
1) and 2) Units: 16LJ28193, 16LJ29064
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone or electronic notification on March 28, 2007 and by letter dated April 4, 2007. 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
4 units
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1338-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1339-12
CODE
1) and 2) Unit: 16GM56754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on March 24, 2007 and by letter dated April 4, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1341-12
CODE
Unit: 5103622 Part 1; 5103622 Part 2
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and follow-up letter on June 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Galileo Echo. Recall # B-1347-12
CODE
Catalog Number - 0087000
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by Technical Communication dated February 29, 20. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Galileo Echo Blood Bank Analyzer with a failed temperature sensor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1,135 units
DISTRIBUTION
Nationwide, Canada, Germany, India, Japan, Korea, and Philippines
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1349-12;
2) Recovered Plasma. Recall # B-1350-12
CODE
1) and 2) Unit: W036812328522
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone and letter on March 3, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland; Florida
___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1352-12
CODE
Units: W036810281673 Part 1; W036810281673 Part 2
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone on February 28, 2012 and by letter on February 29, 2012. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1353-12
CODE
Unit: W045112356716
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by telephone on March 20, 2012. 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
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1355-12
CODE
Unit: W227711301549
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by telephone on March 7, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1357-12
CODE
Units: E25024; E25026
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by email on January 31, 2008 and letter dated February 1, 2008. Firm initiated recall is complete.
REASON
Blood products, in which viral marker testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1359-12
CODE
Unit: 7354182
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF, Pooled. Recall # B-1360-12
2) Cryoprecipitated AHF. Recall # B-1361-12
CODE
1) Pool ID: KR27617 (contains units FS21202, GQ08004, KF58236, LJ76228, and LJ76219), pool ID: KR27618 (contains units KF58237, GQ07995, GQ08006, and KF58226);
2) Unit: GJ16028
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on September 30, 2007. Firm initiated recall is complete.
REASON
Blood products, for which documentation of thaw temperature was missing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1365-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1366-12
CODE
1) and 2) Unit: W043212022097
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on March 7, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Cornea. Recall # B-1367-12
CODE
Units: SD11377OS, SD11337OD
RECALLING FIRM/MANUFACTURER
South Dakota Lions Eye Bank, Inc., Sioux Falls, SD, by letter dated February 22, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                 
Human Corneas, recovered from a donor whose donor eligibility determination was not complete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-1368-12
CODE
Units: LU0371178; LU3071776; LU0378950; LU0382534; LU0386609; LU0387235; LU0389730; LU0390847; LU0392105; LU0392941; LU0396696; LU0397189; LU0400197; LU0400733; LU0402790; LU0403673; LU0405450; LU0406548; LU0408795; LU0414043; LU0414303; LU0415108; LU0415543; LU0422889; LU0424052; LU0425959; LU0426277; LU0428208; LU0428858; LU0429356; LU0430375; LU0430946; LU0431663; LU0432548; LU0433173; LU0433782; LU0435109; LU0435509; LU0437550; LU0438095; LU0440698
RECALLING FIRM/MANUFACTURER
DCI Biologicals Lubbock, LLC, Lubbock, TX, by electronic mail and fax on September 17, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
NY, PA, Israel and United Kingdom
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1369-12
CODE
Unit: W230808503135
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by fax on June 12, 2008. 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
TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma. Recall # B-1303-12
CODE
Unit: 05DTXD7249
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile on October 20, 2006. 
Manufacturer: BioLife Plasma Services, LP, Denton, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1304-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-1305-12
CODE
1) Units: 012X59442, 012X59466, 012X59479, 012Y05612, 012Y05616, 012Z98708, 012Z98745, 012C98723, 012C98736, 012C98754, 012F07242, 012FF64993, 012FF64994, 012FL56875, 012GK67273, 012GM65615, 012GM65641, 012GM65654, 012GY27965, 012KQ81131, 012KQ81173, 012LJ87609, 012LK97364, 012LS28166, 012LS28197;
 
2) Units: 001FOP71798 (2 units), 001FP71805, 001FP71814, 001FP71815 (2 units), 001GK62799, 001LQ37768, 001LQ37775, 001LQ37779, 001P05172, 001P05190 (2 units), 013X40704, 013X41530, 013X41533, 013X41555, 013X41560, 013X41562, 013X41578, 013X41596, 013X41628, 013X41632, 013X41634, 013X41644, 013X42029
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on January 29, 2010 and by letter dated January 30, 2010. Letters dated July 8, 2011 and September 13, 2011. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, which may have reached an unacceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1308-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1309-12
CODE
1) Unit: FM86019;
 
2) Units: FM76065, FM76066, FM76067 (3 PARTS), FM76068 (2 PARTS), FM76070 (2 PARTS), FM86020, FM86021, FM86022 (2 PARTS), FM86023 (2 PARTS), FM86024 (2 PARTS), FM86292 (2 PARTS), FM88319 (2 PARTS), FM88320, FM88321 (2 PARTS), FM88324, FM88326 (2 PARTS), FM91738, FM91746 (2 PARTS), FM92567, FM92570 (2 PARTS), FM92571, FM92572 (2 PARTS), FM92574 (2 PARTS), FM92573 (2 PARTS), FM92576 (2 PARTS), FM92578 (2 PARTS), FM93264, FM93265, FM93268, FM94022, FM94027 (3 PARTS), FM94028 (2 PARTS), FM94029 (2 PARTS), FM94030, FM94032 (2 PARTS), FM94033, FM94034, FM94038 (3 PARTS), FM94039, FM94040, FM94041, FM94042, FM94043 (3 PARTS), FM94045, FM94046 (2 PARTS), FM94047
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and fax starting on October 30, 2006. Firm initiated recall is complete.
REASON
Blood products, stored at a temperature above the acceptable range, were distributed.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
CA, MA, TN, PA and NY
___________________________________
PRODUCT
Platelets. Recall # B-1331-12
CODE
Unit: W141607593597
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on October 10, 2007.
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA. Firm initiated recall is complete. 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
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1337-12
CODE
Units: 16LJ28193, 16LJ29064
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone or electronic notification on March 28, 2007 and by letter dated April 4, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1340-12
CODE
Unit: 16GM56754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on March 24, 2007 and by letter dated April 4, 2007. 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
OH, CA
___________________________________
PRODUCT
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM-197 Protein) --- Prevnar 13 --- One Dose (0.5 mL) FOR IM USE ONLY --- Wyeth Pharm, Inc. US Govt License No. 3 --- NDC 0005-1971-01. Recall # B-1348-12
CODE
Lot: F73652
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on February 10, 2012.
Manufacturer: Pfizer Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine 0.5mL, formulated and filled with an expired serotype 3 conjugate material, was distributed.
VOLUME OF PRODUCT IN COMMERCE
67,770 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1351-12
CODE
Unit: 19LT70648
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter on February 16, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1354-12
CODE
Units: W071212009015; W071212005497
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on February 28, 2012. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1356-12
CODE
Units: 20KS88895; 20KS88896
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on February 16, 2012 and letter on February 19, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1358-12
CODE
Unit: W230808500441
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by fax on February 20, 2008. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with repaired specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
TX
DISTRIBUTION
1 unit
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1362-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1363-12;
3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1364-12
CODE
1) Units: 020FR18564 (Parts 1 & 2), 020FR18565 (Parts 1 & 2), 020FR18566 (Part 1), 020FR18567 (Part 1), 020FR18568 (Parts 1 & 2), 020GR22634 (Parts 1 & 2), 020GR22635 (Part 1), 020P32055 (Part 1), 020P32057 (Part 2), 20P32058 (Part 1), 020P32059 (Parts 1 & 2), 020P32060 (Parts 1 & 2), 020R20551 (Parts 1 & 2), 020R20552 (Part 1), 020R20553 (Parts 1 & 2), 020R20554 (Parts 1 & 2), 020R20555 (Part 1), 020R20556 (Parts 1 & 2);
 
2) Units: 020KS02639, 020KS02663;
 
3) Units: 020P32056 (Parts 1 & 2), 02032057
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Boise, ID, by telephone on May 11, 2006 and by letters dated May 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
MT, UT, ID
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades. Recall # Z-1221-2012
CODE
All lots with expiration dates between August 2011 and August 2016.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Penlon, Ltd., Abingdon, United Kingdom, by letter dated September 21, 2011. 
Manufacturer: Penlon, Ltd., Abingdon, United Kingdom. Firm initiated recall is ongoing.
REASON
Disposable laryngoscope blades incorrectly labeled with wrong size.
VOLUME OF PRODUCT IN COMMERCE
24,940 cartons
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography. a) Model # EXPERTDC75NA, b) model # EXPERTDC55NA. Recall #Z-1358-2012
CODE
a) Serial numbers: 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; b) Serial numbers: 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
RECALLING FIRM/MANUFACTURER
Gendex Dental Systems, Hatfield, PA, by letter dated December 29, 2011. Firm initiated recall is ongoing.
REASON
Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
IA, IL
___________________________________
PRODUCT
SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System; The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Model number: 393-839 for ABL80 FLEX analyzers. Recall # Z-1384-2012
CODE
Serial number(s): 304157, 304160 and 304162 to 305414
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by letters dated January 30th, 2012. Firm initiated recall is ongoing.
REASON
The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
VOLUME OF PRODUCT IN COMMERCE
819 analyzers and 44 signal data PCBs of Part number 903-227
DISTRIBUTION
OH and Internationally
___________________________________
PRODUCT
 Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis. Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017. Recall # Z-1448-2012
CODE
All machines operating on software versions earlier than version 2.8.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated March 30, 2012, and April 3, 2012.
Manufacturer: Fresenius USA, Inc., Walnut Creek, CA. Firm initiated recall is ongoing.
REASON
Increased risk of intraperitoneal volume (IIPV), referred to as Overfill.
VOLUME OF PRODUCT IN COMMERCE
10,146 units
DISTRIBUTION
Nationwide
______ _____________________________
PRODUCT
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012 
CODE
version 2.x
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated March 30, 2012.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling.
VOLUME OF PRODUCT IN COMMERCE
606 units (153 units US and 453 units international)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vacuum Tissue Processor, Model ASP6025; an automated modular tissue processor. The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration. Recall # Z-1473-2012
CODE
Serial numbers 162, 163, 168, 169, 170, 171, 182, 183, 184, 200 through 267
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, by letter dated March 30, 2012.
Manufacturer: Leica Biosystems Nussloch Gmbh, Nussloch, Germany. Firm initiated recall is ongoing.
REASON
There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. The end result may lead to damage or to loss of tissue specimens.
VOLUME OF PRODUCT IN COMMERCE
27 units - U.S., 40 units - Internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders. Recall # Z-1487-2012
CODE
S98-1925-2H; S98-1925-4H All lots and shipments of the software.
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc. Highlands Ranch, CO, by letter dated February 23, 2009. Firm initiated recall is complete.
REASON
Software error may produce incorrect esophageal contraction readings.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, Product Usage: Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1494-2012
CODE
All units of these models.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters beginning April 4, 2012.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Model number H19. Recall # Z-1495-2012
CODE
Serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154 H191036 H191097 H191155 H191037 H191098 H191156 H191038 H191099 H191157 H191039 H191100 H191158 H191040 H191101 H191159 H191041 H191102 H191160 H191042 H191103 H191161 H191043 H191104 H191162 H191044 H191105 H191163 H191045 H191106 H191164 H191046 H191107 H191165 H191047 H191108 H191166 H191048 H191109 H191167 H191049 H191110 H191168 H191051 H191111 H191169 H191052 H191112 H191170 H191053 H191113 H191171 H191054 H191114 H191172 H191055 H191115 H191174 H191056 H191116 H191175 H191057 H191117 H191176 H191058 H191118 H191177 H191059 H191119 H191178 H191060 H191120 H191179
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 13, 2012. Firm initiated recall is ongoing. 
REASON
A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.
VOLUME OF PRODUCT IN COMMERCE
207 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects. Recall # Z-1496-2012
CODE
All Lot Codes within expiration date distributed between January 2010 through April 2012. Lot Numbers: 02120422; 03092011; 05042011; 08112011; 04062011; 04072011; 08102011; 01162012
RECALLING FIRM/MANUFACTURER
Doctor's Research Group, Inc., Southbury, CT, by letter dated April 2012. Firm initiated recall is ongoing.
REASON
Bone cement strength and stiffness fall below specification at body temperature.
VOLUME OF PRODUCT IN COMMERCE
3,100 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. Recall # Z-1504-2012
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
CaridianBCT, Inc., Lakewood, CO, by letter dated June 2011. Firm initiated recall is ongoing.
REASON
Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
VOLUME OF PRODUCT IN COMMERCE
2,459 Machines
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico*** Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB; Catalog C06150MB; Catalog C07120 MB; Catalog C07150MB; Catalog C08120MB; Catalog C08150MB. Indicated for palliation of malignant neoplasms in the biliary tree. Recall # Z-1507-2012;
 
2) Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico*** Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB; Catalog C10080SB; Catalog C12030SB; Catalog C12040SB; Catalog C12060SB; Catalog C12080MB; Catalog C14040SB; Catalog C14060SB; Catalog C14080SB. Indicated for palliation of malignant neoplasms in the biliary tree. Recall # Z-1508-2012
CODE
1) Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698; 15530115, 15536150, 15556366, 15560543; 15530114, 15556368, 15560545, 15562701; 15530113, 15556371, 15560546; 15530112; 15535365, 15556374, 15562702;
 
2) Lot No's. 15535360, 15530747, 15530756, 15530755, 15535363, 15569685, 15530757; 15530754, 15557313; 15530753, 15557311; 15535361
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter dated April 9, 2012.
Manufacturer: Cordis de Mexico, S.A. de C.V., Chihuahua. Mexico. Firm initiated recall is ongoing.
REASON
There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.
VOLUME OF PRODUCT IN COMMERCE
1,262 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: -Loading Car: Shelving unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. Product Usage: The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another. Model #: M4012097, M4012098, M4011084, M4011085 & M4011090. Recall # Z-1522-2012
CODE
Seral #s: 030400905 thru 030381235
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated March 23, 2012. 
Manufacturer: Steris Mexico, Guadalupe, Mexico. Firm initiated recall is ongoing.
REASON
Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) The rollers on the ends of the pivot arms can impact the bottom of the cam slot or draft against the slot if the arms are not adjusted properly. The current design requires precise field adjustments in order to function reliably. 3) Wear of the pins and chamber track surface due to use as the carriage rail pins drag against the sides of the tracks during use. 4) Dislodging of the clips that are located in the elevator assembly and used to lift/lower the cart each cycle.
VOLUME OF PRODUCT IN COMMERCE
523 units
DISTRIBUTION
Nationwide, Brazil and Canada
___________________________________
PRODUCT
Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage: The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System. Catalog number: K6451; Mnemonic: TPSA. Recall # Z-1540-2012
CODE
Lot number 11300BB, exp 10/26/2012
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, NJ, by letter dated April 14, 2012. Firm initiated recall is ongoing.
REASON
Siemens has confirmed a report of leaking Flex(R) reagent cartridge lot 11300BB from Dimension Vista(R) TPSA; when a leaking Flex(R) is used, patient test results may be falsely depressed.
VOLUME OF PRODUCT IN COMMERCE
1,103 cartons
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Trima Accel Automated Blood Collection System, catalog number 917000000. Product Usage: Automated Blood Collection System for use in humans. Recall # Z-1541-2012
CODE
All serial numbers and lots manufactured from 1997 to present.
RECALLING FIRM/MANUFACTURER
CaridianBCT, Inc., Lakewood, CO, by letter dated March 2011. Firm initiated recall is ongoing.
REASON
Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.
VOLUME OF PRODUCT IN COMMERCE
2,278 machines
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Norco Shoulder Pulley. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery. Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers. Recall # Z-1542-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: North Coast Medical Inc., Gilroy, CA, by telephone on July 13, 2011. Manufacturer: Welform Precision, Ltd, Hangzhou, China. Firm Initiated recall is complete.
REASON                                                                                                                                                 
Potential for plastic D-ring to break during use and cause injury.
VOLUME OF PRODUCT IN COMMERCE
2,364 devices
DISTRIBUTION
Nationwide, Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands
___________________________________
PRODUCT
Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use. Recall # Z-1613-2012
CODE
N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002; N7975-004; N7975-005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galil Medical, Inc., Arden Hills, MN, by letter dated April 12, 2012.
Manufacturer: Galil Medical Ltd., Yokneam, Israel. Firm initiated recall is ongoing.
REASON
This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.
VOLUME OF PRODUCT IN COMMERCE
26 kits
DISTRIBUTION
Nationwide, Canada, Denmark, France, Netherlands, Taiwan and United Kingdom
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
1) Sterile wound closure strips, packaged as follows: DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-203, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-204, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-206, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-212, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-213, STERILE R, Wound Closure Strips, REF 46-214, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-215, STERILE R, DeRoyal EPISEAL, Wound Closure Strips, REF 46-216, STERILE R. Recall # Z-1421-2012
 
2) Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, DeRoyal MINOR INTERVENTIONAL TRAY, REF 89-3559.11, STERILE EO, Rx Only, DeRoyal MAJOR VASCULAR TRAY, REF 89-6561.09, STERILE EO, Rx Only, DeRoyal ICD PACEMAKER TRAY, REF 89-3565.12 and 89-3565.13, STERILE EO, Rx Only, DeRoyal BREAST TRAY, REF 89-3564.06, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-3831.10, STERILE EO, Rx Only, DeRoyal ENDO SINUS TRAY, REF 89-3896.07, STERILE EO, Rx Only, DeRoyal MP-004 STEREOTACTIC TRAY, REF 89-4003.04, STERILE EO, Rx Only, DeRoyal BIOPSY TRAY MP-007, REF 89-4049.01, STERILE EO, Rx Only, DeRoyal BREAST AUGMENTATION TRAY, REF 89-4087.02, STERILE EO, Rx Only, DeRoyal SPINE PACK, REF 89-4150.05, STERILE EO, Rx Only DeRoyal KNEE ARTHROSCOPY TRAY, REF 89-4185.08, STERILE EO, Rx Only, DeRoyal ACL TRAY, REF 89-4195.08, STERILE EO, Rx Only, DeRoyal ACL TRAY, REF 89-4270.06, STERILE EO, Rx Only, DeRoyal CARDIOVASCULAR PACK, REF 89-4712.09, STERILE EO, Rx Only, DeRoyal CARDIOVASCULAR PACK, REF 89-4932.03, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-4955.04, STERILE EO, Rx Only, DeRoyal ULTRA/MAMO TRAY, REF 89-4990.02, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-4955.04, STERILE EO, Rx Only, DeRoyal LTX-SAFE STND-KNEE ARTHROSCOPY, STANDARD TRAY, REF 89-5032.01, STERILE EO, Rx Only, DeRoyal STANDARD LAP CHOLE PACK, REF 89-5059.01, STERILE EO, Rx Only, DeRoyal EXTREMITY TRAY, REF 89-5102.03, STERILE EO, Rx Only, DeRoyal KNEE ARTHRO TRAY, REF 89-5103.03, STERILE EO, Rx Only, DeRoyal CATARACT PACK PGYBK, REF 89-5173.01, STERILE EO, Rx Only, DeRoyal RETINA EYE TRAY, REF 89-5228.07, STERILE EO, Rx Only, DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05, STERILE EO, Rx Only, DeRoyal MINOR BASIN, REF 89-5293.07, STERILE EO, Rx Only, DeRoyal VEIN TRAY, REF 89-5341.01, STERILE EO, Rx Only, DeRoyal SHOULDER ARTHRO PACK, REF 89-5383.04, STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5488.02, STERILE EO, Rx Only, DeRoyal FISTULA / ARTERIOGRAM, REF 89-5545.02, STERILE EO, Rx Only, DeRoyal VITRECTOMY PACK, REF 89-5559.08, STERILE EO, Rx Only, DeRoyal LAP PACK, REF 89-5562.03, STERILE EO, Rx Only, DeRoyal VENACURE PROCEDURE PACK, REF 89-5565.03, STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5655.01, STERILE EO, Rx Only, DeRoyal RETINA, REF 89-5657.04, STERILE EO, Rx Only, DeRoyal ACL PACK, REF 89-5687.01, STERILE EO, Rx Only, DeRoyal LAPAROSCOPY PACK, REF 89-5711.02, STERILE EO, Rx Only, DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-5820.01, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-5901.02, STERILE EO, Rx Only, DeRoyal BASIC TRAY, REF 89-6211.01, STERILE EO, Rx Only, DeRoyal LAPAROTOMY PACK, REF 89-6234.03, STERILE EO, Rx Only, DeRoyal ENDOVENOUS PACK, REF 89-6344.02, STERILE EO, Rx Only, DeRoyal LAP CHOLE PACK, REF 89-6397.04, STERILE EO, Rx Only, DeRoyal MIRIAM DEVICE TRAY, REF 89-6478.03, STERILE EO, Rx Only, DeRoyal VEIN PACK, REF 89-6509.01, STERILE EO, Rx Only, DeRoyal VEIN PACK, REF 89-6642.03, STERILE EO, Rx Only, DeRoyal VEIN TRAY, REF 89-6671.01, STERILE EO, Rx Only, DeRoyal LAPAROSCOPIC GYN PACK, REF 89-6724.01, STERILE EO, Rx Only, DeRoyal ACL TRAY, REF 89-6814.03, STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY TRAY, REF 89-6816.03, STERILE EO, Rx Only, DeRoyal SHOULDER PACK, REF 89-6830.0510, STERILE EO, Rx Only, DeRoyal CV TRAY, VENOUS & ARTERIAL SURGERY, REF 89-6844.02, STERILE EO, Rx Only, DeRoyal IMPLANT PACK, REF 89-6981.03, STERILE EO, Rx Only, DeRoyal LAPAROSCOPY PACK-LF, REF 89-7061.01, STERILE EO, Rx Only, DeRoyal LAPAROSCOPIC ROBOTIC PACK, REF 89-7063.01, STERILE EO, Rx Only, DeRoyal ORTHO SPORTS UCL SUPPLEMENTAL PACK, REF 89-7072.02, STERILE EO, Rx Only, DeRoyal TORR VEIN TRAY, REF 89-7112.01, STERILE EO, Rx Only, DeRoyal ACOUSTIC PACK, REF 89-7158.01, STERILE EO, Rx Only, DeRoyal BASIC PACK, REF 89-7449.02, STERILE EO, Rx Only, DeRoyal ANGIOGRAPHY DRAPE PACK, REF 89-7462.03, STERILE EO, Rx Only, DeRoyal HAND PACK, REF 89-7549.02, STERILE EO, Rx Only, DeRoyal ANGIOGRAPHY DRAPE PACK, REF 89-7613.01, STERILE EO, Rx Only, DeRoyal NERVE BLOCK TRAY, REF 89-7646.02, STERILE EO, Rx Only, DeRoyal OASIS EYE PACK, REF 89-7688.01, STERILE EO, Rx Only, DeRoyal PROGRESSIVE EYE PACK, REF 89-7693.02, STERILE EO, Rx Only, DeRoyal NEONATAL/PED PICC INSERTION TRAY PGYBK, REF 89-7758.01, STERILE EO, Rx Only, DeRoyal INTL-NEONATAL OPEN HEART PGYBK, REF 89-7871.01, STERILE EO, Rx Only, DeRoyal ENDOVENOUS PACK, REF 89-7762.01, STERILE EO, Rx Only, DeRoyal BIOPSY PROCEDURE PACK, REF 89-7768.01, STERILE EO, Rx Only, DeRoyal NEURO PACK, REF 89-7880.01, STERILE EO, Rx Only, DeRoyal BIOPSY TRAY-MP-008, REF 89-7896, STERILE EO, Rx Only, GEO-MED, PACEMAKER PACK, REF 89-6317.02, STERILE EO, Rx Only, GEO-MED, ARTHROSCOPY PACK, REF 89-6371.03, STERILE EO, Rx Only, GEO-MED, SHOULDER ARTHROSCOPY PACK, REF 89-6432.01, STERILE EO, Rx Only, GEO-MED, NEURO LAMINECTOMY PACK, REF 89-6501.02, STERILE EO, Rx Only, GEO-MED, ENT MINOR PACK, REF 89-6609.04, STERILE EO, Rx Only, GEO-MED, PACEMAKER DEVICE PACK, REF 89-6643.01, STERILE EO, Rx Only, GEO-MED, PACEMAKER PACK, REF 89-6717.02, STERILE EO, Rx Only, GEO-MED, MINOR SURGICAL SET UP PACK, REF 89-7900.01, STERILE EO, Rx Only. Recall # Z-1422-2012;
 
3) Non-sterile wound closure strips, packaged as follows: DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-204N, DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N. Recall # Z-1423-2012
CODE
1) REF 46-202, Lot Number: 346935; REF 46-203, Lot Numbers: 345495, 362263; REF 46-204, Lot Numbers: 350142, 344274; REF 46-206, Lot Numbers: 342708, 2360103; REF 46-212, Lot Numbers: 352631, 345230; REF 46-213, Lot Number: 350152; REF 46-214, Lot Numbers: 344278, 345232; REF 46-215, Lot Number: 345242; REF 46-216, Lot Numbers: 585961, 350276;
 
2) REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374, 25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF 47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47-732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47-787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 50-7104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 50-7195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324, 26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 50-9786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361, 25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers: 26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297, 26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537, 24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103, 26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521; REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440, 26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713, 26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448, 26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 89-0323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721, 27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345, 25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439, 26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 89-2703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775, 25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911, 25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710, 27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921, 26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103, 25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 89-3190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100, 25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers: 27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134; REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458, 26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 89-3472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218, 27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458, 25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579; REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684, 27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504, 26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507, 25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374, 26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006, 25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821, 26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers: 25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541, 27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786, 25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF 89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174, 25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633, 25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575; REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007, 25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969, 26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044, 27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers: 27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433, 27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258, 25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523, 27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033, 26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639, 24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759, 27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446, 27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023, 26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050, 26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522, 27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306, 25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069, 26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers: 26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150; REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735, 26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers: 27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602, 26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946, 24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers: 27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249; REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848, 25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236, 26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921, 25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061, 25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598, 26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 89-5901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268, 27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010, 24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900, 26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044, 25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers: 27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 89-6478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450, 26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071, 24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985, 25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111, 26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 89-6724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838, 24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842, 25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers: 27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021, 26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751, 27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101, 26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234, 24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251, 26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419, 27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977, 25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752, 26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795, 25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242, 26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671; REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485, 26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109, 27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821, 26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137, 25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191, 25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528, 26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902, 24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116, 26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 89-7613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696, 27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620, 26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410, 25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501; REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers: 26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741, 26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers: 27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912, 28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491, 26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436, 25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 89-6371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682, 25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344; REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560, 26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 89-6717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460, 27981494, 28016813, 28039;
 
3) REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers: 28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and 25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275, 26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957, 25068811
RECALLING FIRM/MANUFACTURER
Deroyal Industries, Inc. Lafollette, La Follette, TN, by letter dated February 7, 2012. Firm initiated recall is ongoing.
REASON
Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
VOLUME OF PRODUCT IN COMMERCE
205,661 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route. Recall # Z-1481-2012
CODE
Lot numbers: 2936642, 2967400
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Manufacturing US, LLC, Minneapolis, MN, by letter dated March 2, 2012. 
Manufacturers: Coloplast A/S, Humlebaek, Denmark;
Culzean Medical Devices Limited, Prestwick, United Kingdom.
Firm initiated recall is ongoing.
REASON                                                                                                                                                
Two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size as 16x11 cm, however, the correct size is actually 14x15 cm. It is important to note that both the product and box labels were correct.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL. Recall # Z-1645-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 11, 2011.
Manufacturer: Beckman Coulter, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent.
VOLUME OF PRODUCT IN COMMERCE
90,965 units total (24,951 units in US)
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
___________________________________
PRODUCT
1) RIVER RUN(R), Professional Formula, 27-18 Dog Food, Net Wt. 50 LB (22.67 kg). Recall # V-067-2012;
 
2) RIVER RUN(R), 21% Protein Dog Food, Net Wt. 40 lb (18.14 kg) and 50 lb (22.67 kg). Recall # V-068-2012;
 
3) PROFESSIONAL FORMULA, RIVER RUN(R), HI-NRG 24-20, Dog Food, Net Wt. 50 lb (22.67 kg). Recall # V-069-2012;
 
4) RIVER RUN(R), Hi-Pro No-Soy Dog Food, Net Wt. 40 lb (18.14 kg) and 50 lb  (22.67 kg). Recall # V-070-2012;
 
5) MARKSMAN(R), Dog Food, 28% Protein 18% Fat, Net Wt. 40 LB (18.14 kg). Recall # V-071-2012;
 
6) MARKSMAN(R), Dog Food, 24% Protein 20% Fat, Net Wt. 40 lb (18.14 kg). Recall # V-072-2012;
 
7) MARKSMAN(R), Dog Food, 20% Protein 10% Fat, Net Wt. 40 lb (18.14 kg) and 50 lb (22.67 kg). Recall # V-073-2012
CODE
1) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
2) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
3) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
4) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
5) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
6) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335;
 
7) Units: 4K0335 - 4K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335
RECALLING FIRM/MANUFACTURER
Cargill Inc Animal Nutrition Division, Lecompte, LA, by telephone on December 2, 2011, by press release on December 6, 2011 and by letter on December 12, 2011. Louisiana initiated recall is ongoing.
REASON
Dog food may have elevated levels of Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
291,508 units
DISTRIBUTION
KS, MO, OK, AR, LA, MS, TN, KY, IN, IL, HI, Guam, the U.S. Virgin Islands, FL, CA, Bahamas, and Chile
 
END OF ENFORCEMENT REPORT FOR MAY 23, 2012
 
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