Safety
Enforcement Report for November 10, 2010
November 10, 2010 10-44
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Golden Bridge brand Dried Date, Net Wt: 12 oz (340g), UPC 8 24342 01008 0, Product of China, Nutrition Facts: Serving Size 14 oz. (397 g), Servings per Container 1. The product is packaged in a sealed flexible plastic bag. Recall # F-0127-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Sunny Lake Trading, Inc., Brooklyn, NY, by telephone on August 18, 2010. New York State initiated recall is complete.
REASON
The product contains undeclared sulfites (155 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY City
___________________________________
PRODUCT
PictSweet Breaded Okra, Quick Frozen from the Farm. Net Wt. 32 oz. (2 lb) 907g. Recall # F-0128-2011
CODE
Production codes begin with the following five digits: 1400B; 1550B; 1660B; 1730B; 1870B; 2030B; 2350B; 2500B
RECALLING FIRM/MANUFACTURER
The PictSweet Co., Bells, TN, by telephone and letter on October 11, 2010. Firm initiated recall is ongoing.
REASON
Product contains undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
22,799 cases of 6/32 oz. bags
DISTRIBUTION
AL, FL, GA, LA, MS, NC, NH, SC, TN, TX
___________________________________
PRODUCT
1) Limpert's Hazelnut Base, Net Contents 3 quarts (2.85 liters). Made in the USA. Item number 5026. Recall # F-0129-2011;
2) Limpert's Spumoni Fruit Mix, Net contents 3 quarts (2.85 liters). Item Number: H-3480. Made in USA. Recall # F-0130-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Limpert Brothers, Inc., Vineland, NJ, by letters on September 30, 2010 and October 5, 2010. FDA initiated recall is ongoing.
REASON
Recent FDA inspection found Allergen labeling issues: Hazelnut base did not include Soy Nut Butter in the ingredient listing and Spumoni label stated "nutmeats" in stead of almonds.
VOLUME OF PRODUCT IN COMMERCE
1) 16 cases; 2) 15 cases and 24.5 gal pails
DISTRIBUTION
MA, NJ, VA, OH, FL, PA
___________________________________
PRODUCT
Lucerne brand Oregon Bread's Western Hazelnut Bread (white bread only) in 24 oz pack, The UPC Product Code: 3945500371. Recall # F-0140-2011
CODE
BEST BY DATES: Sept. 06-through 11-Oct.
RECALLING FIRM/MANUFACTURER
Safeway, Inc., Pleasanton, CA, by letters, press release, e-mails and telephone on October 4, 2010. Firm initiated recall is ongoing.
REASON
The product contains undeclared cashews, almonds and Brazil nuts in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
32,334 loaves
DISTRIBUTION
CA, ID, OR, NV, UT, WA, MT, CO, NM, WY, SD, NB, AK
___________________________________
PRODUCT
a) Celery Diced 1/2", 4/5# Unit; and b) Celery Diced 1/4", 4/5# Unit, PO #142980. Recall # F-0141-2011
CODE
a) Use by date 10/10/10; b) Born On date 10/11/10
RECALLING FIRM/MANUFACTURER
Sangar Fresh Cut Produce, Co., LLC, San Antonio, TX, by telephone on October 12, 2010 and by letters on October 19, 2010. Texas initiated recall is ongoing.
REASON
Product has the potential to contain Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
105 lbs
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Coca Cola Classic, 12 oz cans (packed in 6, 12, 24 and 32 packs). Recall # F-0131-2011
CODE
Optimum Taste Codes: JUN1311VM A and JUN1311VJ D
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Co., Atlanta, GA, by e-mail, telephone and visit beginning October 15, 2010.
Manufacturer: Coca Cola Bottling Company of Oregon, Wilsonville, OR; and
Coca Cola Bottling Co. of WA, Inc., Bellevue, WA. Firm initiated recall is ongoing.
REASON
The packaging of these specific lots has integrity issues due to lack of liner adhesion and inner coke can lining peeling off as particles in the soda.
VOLUME OF PRODUCT IN COMMERCE
50170 cases (packed 6, 12, 24 and 32/12 oz cans per case)
DISTRIBUTION
CA, OR, WA
___________________________________
PRODUCT
1) Bulk Frozen Pasta packaged in a 3lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Four Cheese Ravioli, Ingredients: Ricotta, Mozzarella, Pecorino, Parmesano. Lilly's Gourmet Pasta. Production Date: Julian Date --10-050 is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk and pasta product is prepared with wheat and whole eggs). Recall # F-0133-2011;
2) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Lobster Ravioli. Ingredients: Main Lobster meat, ricotta, crab, spices. Lilly's Gourmet Pasta. Production Date: Julian Date --10-050 is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk and pasta product is prepared with wheat and whole eggs). Recall # F-0134-2011;
3) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Porcini-Ravioli. Ingredients: Porcini, wild mushroom, mozzarella, parmesano. Lilly's Gourmet Pasta. Production Date: Julian Date --10-050 is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk and pasta product is prepared with wheat and whole eggs). Recall # F-0135-2011;
4) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Pumpkin Ravioli. Ingredients: Butternut squash, ricotta, amoretti, mostarda, parmesano. Lilly's Gourmet Pasta. Production Date: Julian Date --10-050 is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk and pasta product is prepared with wheat and whole eggs). Recall # F-0136-2011;
5) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Potato-Gnocchi. Ingredients: Potato, durum flour, eggs, pecorino, salt, spices. Lilly's Gourmet Pasta. Production Date: Julian Date --10-050 is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk & whey solids.). Recall # F-0137-2011;
6) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Seafood Mornay, Ingredients: Srimps; Scallops; Snow Crab; Ricotta. Lilly's Gourmet Pasta. Production Date: Julian Date is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk & whey solids.) (Undeclared ingredients/sub-ingredients - Ravioli Pasta was not mentioned in the labeling nor were the ingredients wheat and whole eggs. Note: No incorrect labeling was provided to the investigator. Investigator did obtain the corrected labeling. At this late date the firm cannot provide a copy of any incorrect labeling for this product. Recall # F-0138-2011;
7) Bulk Frozen Pasta packaged in a 3 lb clear plastic bag then placed 5 bags in a Cardboard Carton with final weight of 15 lbs. Spinach-4/Cheese-Ravioli, Ingredients: Fresh Spinach, Ricotta Cheese; Mozzarella Cheese; Pecorino/Parmesan Cheese; Bread Crumbs. Lilly's Gourmet Pasta. Production Date: Julian Date is placed on outside of bulk cardboard carton. (Undeclared sub-ingredients - cheese ingredients were labeled as containing milk & whey solids.) (Undeclared ingredients/sub-ingredients - Ravioli Pasta was not mentioned in the labeling nor were the ingredients wheat and whole eggs. Note: No incorrect labeling was provided to the investigator. Investigator did obtain the corrected labeling. At this late date the firm cannot provide a copy of any incorrect labeling for this product. Recall # F-0139-2011
CODE
1) Lot Codes: 10-032-4 Cheese Pasta through 10-120-4 Cheese Pasta;
2) Lot Codes: 10-032-Lobster Pasta through 10-120-Lobster Pasta;
3) Lot Codes: 10-032-Porcini Ravioli through 10-120-Porcini Ravioli;
4) Lot Codes 10-032-Pumpkin Ravioli through 10-120-Pumpkin Ravioli;
5) Lot Codes: 10-032-Potato Gnocchi through 10-120-Potato Gnocchi;
6) Lot Codes: 10-032-Seafood Mornay through 10-120-Seafood Mornay;
7) Lot Codes: 10-032-Spinach 4/CH Ravioli through 10-120-Spinach 4/CH Ravioli
RECALLING FIRM/MANUFACTURER
Lilly’s Gastronomical Italiana of Florida, Inc., Miami, FL, by telephone on April 30, 2010. FDA initiated recall is ongoing.
REASON
Firm failed to declare milk and wheat as allergens on the product labeling.
VOLUME OF PRODUCT IN COMMERCE
46 cases
DISTRIBUTION
FL
_____________________________________
PRODUCT
1) White Corn Meal, White paper package with red and blue lettering. Net weight is 2 lbs. UPC 041460401778. Recall # F-0142-2011;
2) White Corn Meal, White paper package with red and blue lettering. Net weight is 5 lbs. UPC 041460401518. Recall # F-0143-2011;
3) White Corn Meal, White paper package with red and blue lettering. Net weight is 25 lbs. UPC 10041460401263. Lot code is PM0231. Recall # F-0144-2011
CODE
1) Lot # PL0239;
2) Lot # PL0233;
3) Lot # PM0231
FIRM/MANUFACTURER
CH Guenther & Sons, Inc., San Antonio, TX, by letter on October 1, 2010. Firm initiated recall is ongoing.
REASON
White Corn Meal tested above FDA’s acceptable limit for Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
3,087 packages
DISTRIBUTION
NM, TX, IL, FL, ID, LA, AZ, IA
_____________________________________
PRODUCT
Sunmet pomegranate juice concentrate, bulk. Recall # F-0146-2011
CODE
Lot codes: PO2809, PO2869, PO2939, PO3029, and PO3089
FIRM/MANUFACTURER
Sunmet Juice Company LLC, Arvin, CA, by letter on November 4, 2010. Firm initiated recall is ongoing.
REASON
Pomegranate Juice Concentrate contains elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
160 drums
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) METROnidazole Injection, USP, 500 mg/100 mL (5 mg/mL), 100 mL Single Dose Container bag, 24 x 100 mL bags per case, Rx only, NDC 36000-001-24. Recall # D-026-2011;
2) Ciprofloxacin in Dextrose (5%) Injection, 200 mg in 100 mL 5% dextrose (2 mg/mL), 100 mL Single dose flexible plastic container bag, 24 bags x 100 mL per case, Rx only, NDC 36000-008-24. Recall # D-027-2011;
3) Ciprofloxacin in Dextrose (5%) Injection, 400 mg in 200 mL (5)% Dextrose (2mg/mL), 200 mL Single dose flexible plastic container bag, 24 bags x 200 mL per case, Rx only; NDC 36000-009-24. Recall # D-028-2011;
4) ONDANsetron in 5% Dextrose Injection, 32 mg/50 mL (0.64 mg/mL); 50 mL Single use plastic container bag, 6 bags x 50 mL per case, Rx only, NDC 36000-014-06. Recall # D-029-2011
CODE
1) Lot #: A080536, A080537, Exp 06/30/10; A080612, A080613, A080614, A080615, A080616, A080617, A080628, A080629, Exp 07/31/10; A080634, A080635, A080640, A080641, Exp 08/31/10; A090098, A090100, A090115, A090116, A090117, A090119, A090120, A090121, A090122, Exp 02/28/11; A090157, A090158, A090192, A090193, A090194, Exp 03/31/11; A090195, A090197, A090198, A090199, A090200, A090207, A090208, A090209, A090210, A090222, A090232, A090233, A090234, Exp 04/30/11; A090354, A090394, A090398, Exp 05/31/11; A090403, A090407, A090438, A090439, A090440, A090447, A090448, A090449, A090459, A090460, A090461, A090482, A090483, A090484, A090485, A090486, A090493, A090506, A090507, Exp 06/30/11; A090527, A090528, A090534, A090576, A090583, A090584, A090588, Exp 07/31/11; A090654, A090655, Exp 08/31/11; A090951, A090952, A090953, A090965, A090966, Exp 11/30/11;
2) Lot #: A080154, A080156, A080157, Exp 02/28/10; A080530, A080531, A080532, Exp 06/30/10; A090418, Exp 07/31/11; A090950, Exp 11/30/11;
3) Lot #: A080158, A080162, A080163, Exp 02/28/10; A080164, A080245, A080246, A080247, A080248, A080255, A080256, A080257, A080262, A080263, A080264, A080267, Exp 03/31/10; A080270, A080271, A080272, A080273, A080274, A080275, A080276, A080277, A080278, A080279, A080306, A080307, A080308, A080309, A080310, Exp 04/30/10; A080596, A080597, A080598, A080601, A080604, A080605, A080606, A080607, A080608, Exp 07/31/10; A090169, A090170, A090171, A090172, A090173, A090174, A090182, A090183, A090188, Exp 03/31/11; A090254, A090255, A090272, A090273, A090274, A090275, A090276, A090277, Exp 04/30/11; A090330, A090331, Exp 05/31/11; A090410, A090411, A090412, A090428, A090429, A090430, Exp 06/30/11; A090515, A090517, A090518, A090533, A090593, A090594, A090598, Exp 07/31/11; A090932, A090933, Exp 10/31/11; A090939, A090941, A090942, A090986, A090987, Exp 11/30/11;
4) Lot #: A090008, A090009, A090013, Exp 12/31/10; A090261, A090262, A090263, A090284, Exp 04/30/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Claris LifeSciences, Inc., North Brunswick, NJ, by letters dated May 30, 2010, and by telephone, fax, e-mail and press release on June 1, 2010.
Manufacturer: Claris LifeSciences Limited, Ahmedabad, India. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The intravenous medication ciprofloxacin is being recalled for lack of assurance of sterility because they may be contaminated with mold, fungus, and/or bacteria.
VOLUME OF PRODUCT IN COMMERCE
50,170 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Avalide Tablets, (irbesartan/hydrochlorothiazide), 300/25 mg, 2, 7 and 14 count blister packs and 30 and 90 count bottles. Also labeled as 1) Coaprovel; also 2) Karvezide and 3) Avapro HCT. Recall # D-030-2011
CODE
90 count: 8J36036A , 8J36040A, 8J36041A, 8J36044A, 8J36046A, 8J36047A, 8K35927A, 8K35925A, 8K35935A, 8K35950A, 8K35954A, 8K35955A, 8K35957A, 8K35960A, 8K35963A, 8M27617A, 8M27619A, 8M29523A, 8M29528A, 9A55780A, 9A55781A, 9A55782A, 9A55789A, 9C48867A, 9E53024A, 9E53027A, 9E53029A, 9E53030A, 9F49882B, 9F49886A, 9F49889A, 9F49890A, 9F49893A, 9J47021A, 9J47023A, and 9J47027A --- 30 count: 8J36039A, 8J36042A, 8J36043A, 8J36045A, 8K35928A, 8K35930A, 8K35931A, 8K35932A, 8K35936A, 8K35951A, 8K35952A, 8K35956A, 8K35961A, 8K35964A, 8M27615A, 8M27616A, 8M29524A, 8M29526A, 8M29527A, 9A55786A, 9A55787A, 9E53023A, 9E53025A, 9E53026A, 9E53031A, 9E53032A, 9F49883A, 9F49884A, 9F49892A, 9J47024A, 9J47025A, 9J47029A, and 9J47030A ---- 2 Blister x14: 8K5936 2, 9A55790 3, 9F49888 5, and 9A55790 1 ---- 1 Blister x 7: 8K35953A, 8M27618A, 9E53028A, 9F49887A, and 9A55793A --- 1 Blister x 14: 8K35936 3, 9A55790 2, 9F49888 2, and 9F49888 4 ---- 1 Blister x 2: 9F49888 3, and 9F49888 1 ---- Coaprovel distributed in Mexico and Argentina: Blisters (2 BLP x 14) E018K35936, E028K35936, E038K35936, E048K35936, E058K35936, E068K35936, 8K35936 1, F359A55790, 9A55790 4, F839F49888, K599F49888, K609J47023, 9J47025 1 --- Blisters (1 BLP x 14) C658K35936, F349A55790, F339A55790, F829F49888 --- and Blisters (1 BLP X 2) 9A55790 5 ---- Karvezide Distributed in Australia: 30 count: 921721, 923531, 922011, 925041, 925911, 924411, 928451, and 928421 ---- Avapro HCT distributed in Australia: 30 count: 922131, 923371, 923551, 923521, 925341, 926941, and 928471
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Manufacturing Co., Humacao, PR, by letter on September 10, 2010. Firm initiated recall is ongoing.
REASON
GMP Deviation: During manufacturing, the granulation time for the finished drug product was extended, which resulted in varying levels of Polymorph Form B. Polymorph Form A is the intended form. Polymorphism is the existence of different kinds/forms of crystal of the same chemical compound. In this case the extended granulation time changed Polymorph Form A to varying levels of Polymorphic Form B.
VOLUME OF PRODUCT IN COMMERCE
2,222,828
DISTRIBUTION
Nationwide, Canada, Mexico, Argentina and Australia
___________________________________
PRODUCT
Alcohol-Free Hand Sanitizer Foam; brand names: 1) i) Smart San Alcohol-Free Hand Sanitizer Foam, 1250mL bottles, NDC: 59900-118-06; Product code: SMA0031U SmartSan; ii) 45mL, NDC 59900-118-48, Product code: PL0083 ODO San; 2) ODO San Alcohol-Free Hand Sanitizer Foam, 1250mL bottles; NDC: 52296-118-01; Product code: SMA0031U SmartSan; Product code: SMA0026U SmartSan. Recall # D-031-2011
CODE
Lot number: 101121, Exp: 4/12; Lot number: 101131, Exp: 4/12; Lot number: 101161, Exp 4/12; Lot number: 101161, Exp 4/12; Lot number: 101171, Exp 4/12; Lot number:101961, Exp: 7/12; Lot number:101971, Exp: 7/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Sanitizers, Inc., Penn Valley, CA, by telephone and letters on October 7, 2010.
Manufacturer: Best Sanitizers, Inc., Walton, KY. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
183 cases (1,182 bottles)
DISTRIBUTION
AR, CA, FL, HI, IA, MO, NC, PA
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-2423-10
CODE
Units: 07EWII2475, 07EWII1180, 07EWII0370, 07EWIH8742
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by e-mail on June 13, 2008.
Manufacturer: BioLife Plasma Services, LP, Eau Claire, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received an MMR vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2463-10
CODE
Unit: 72F952662
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., - Birmingham Region, Birmingham, AL, by fax on May 28, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2466-10
CODE
Unit: 72F73538X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on May 21, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2467-10
CODE
Unit: 72F807563
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by fax on June 9, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2468-10
CODE
Unit: 72F818516
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by fax on June 11, 2008.
Manufacturer: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2481-10
CODE
Units: W035208194510V; W035208200274F; W0352082000614; W035208197979K; W035208197984Q; W0352081992789
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 4, 2008 and follow-up letter dated December 10, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-2484-10
CODE
Units: TA2142379; TA2142666; TA2143360; TA2143532; TA2144120; TA2144368; TA2144945; TA2145221; TA2145743; TA2146229; TA2146626; TA2147054; TA2147449; TA2147882; TA2148426; TA2155138; TA2155277; TA2155990; TA2156101; TA2156808; TA2156906; TA2157506; TA2157750; TA2158346; TA2158570; TA2159125; TA2159366; TA2159846; TA2160213; TA2160727; TA2160981; TA2161533; TA2161737; TA2162326; TA2162526; TA2163001; TA2163209; TA2163686; TA2163852; TA2164312; TA2164530; TA2165026; TA2165220; TA2165736
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by letter on July 30, 2008.
Manufacturer: DCI Biologicals Texarkana LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
England
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2499-10
CODE
Unit: 53GR74118
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on December 15, 2005 and by letter on December 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2500-10
CODE
Unit: GR75793
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc, Milwaukee, WI, by electronic notification on July 16, 2007. Firm initiated recall is complete.
REASON
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2504-10
CODE
Unit: 53P10264
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on October 2, 2007 and by letter dated June 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected during instrument re-validation without QC being performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2508-10
CODE
Unit: 35Y85066
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Roanoke, VA, by telephone on October 5, 2007 followed by a letter dated November 8, 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
VA, CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2511-10
CODE
Units: 1555164, 1556086, 1556088, 1556087, 1557573
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on April 30, 2007. Firm initiated recall is complete.
REASON
Blood components, processed from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2537-10
CODE
Unit: 1427415
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on July 10, 2006. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2538-10
CODE
Unit: 72H439432
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on August 6, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Shelby Talladega, Alabaster, AL. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2539-10
CODE
Unit: 6908677
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated December 28, 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2541-10
CODE
Units: 1458017, 1458019
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated November 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who emigrated from a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2542-10
CODE
Unit: 1445760
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated March 2, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria and leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-2543-10
CODE
Unit: P11986
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated November 24, 2006. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2544-10
CODE
Units: W012008001585; W012008001585
RECALLING FIRM/MANUFACTURER
Department of the Army, US Army Blood Bank Center, Fort Hood, TX, by fax on June 5, 2008. 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
NJ, FL
___________________________________
PRODUCT
Blood Products – Other. Recall # B-2545-10
CODE
Unit: P11994
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on November 10, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date following pooling, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2546-10
CODE
Units: 6878193; 6878193; 1411462; 1411462; 1414804; 1414804 (double units)
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated November 7, 2005. 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
6 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2548-10
CODE
Unit: 1426932
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated July 25, 2006. Firm initiated recall is complete.
REASON
Blood product, for which there was incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2549-10
CODE
Unit: 1444668
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on December 23, 2005. Firm initiated recall is complete.
REASON
Blood product, contaminated by air during filtration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2550-10
CODE
Unit: 1421557
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated February 21, 2006. Firm initiated recall is complete.
REASON
Blood product, with unacceptably high platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-2552-10
CODE
Units: 6030180034; 6030177279
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by fax on February 11, 2006.
Manufacturer: ZLB Plasma, Corpus Christi, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose annual physical exam was overdue, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2554-10;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2555-10
CODE
1) Units: 1421418; 1419759;
2) Unit: 1415438
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated May 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, FL
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced Irradiated. Recall # B-2580-10
CODE
Unit: F209826-2
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on February 3, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2581-10
CODE
Unit: Y205438
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on January 20, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2582-10
CODE
Unit: Z123204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on February 7, 2005.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. 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
WA
_______________________________
PRODUCT
Recovered Plasma. Recall # B-2583-10
CODE
Units: W170693, K171594, K168382, L160943, A151028, S155129, P134575, W147318
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on March 30, 2005.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. 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
8 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-2584-10
CODE
Units: B218791-3, B218793-1, B218793-2, B218796-1
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on May 21, 2005.
Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-2617-10
CODE
Units: 08SPAB4025, 08SPAB4733, 08SPAB5257, 08SPAB6021, 08SPAB6532, 08SPAB7202, 08SPAC1554, 08SPAC1813, 08SPAC2308, 08SPAC2760, 08SPAC3078, 08SPAC3520, 08SPAC3869, 08SPAC4172, 08SPAC4644, 08SPAC4894, 08SPAC5428, 08SPAC5712, 08SPAC6230, 08SPAC6463, 08SPAC6950, 08SPAC7180, 08SPAC7680, 08SPAC7880, 08SPAC8972, 08SPAC9201, 08SPAD0423, 08SPAD0714, 08SPAD1224, 08SPAD1519, 08SPAD2027, 08SPAD2342, 08SPAD2908, 08SPAD3795, 08SPAD4121, 08SPAD4719, 08SPAD6101, 08SPAD6795, 08SPAD7163, 08SPAD7831
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by letter dated April 7, 2010.
Manufacturer: BioLife Plasma Services, LP, State College, PA. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2620-10
CODE
Unit: H164158
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on February 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for the Kell red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2622-10
CODE
Unit: 4474125
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letter dated October 20, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ID
___________________________________
PRODUCT
AS-5 Red Blood Cells Adenine-Saline Solution Added. Recall # B-2626-10
CODE
Unit: U125967
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone and letter dated July 21, 2005.
Manufacturer: Puget Sound Blood Center and Program, Renton, WA. 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
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2627-10
CODE
Unit: 9955196 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 26, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-2655-10
CODE
Unit: 06MMTA4975
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Missoula, MT, by facsimile on April 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received the MMR vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2661-10
CODE
Units: 05MMTC6155, 05MMTC6476
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Missoula, MT, by facsimile on April 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received the MMR vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2669-10
CODE
Unit: 4393925
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on December 3, 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
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2670-10
CODE
Unit: 6103699
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by facsimile on November 7, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2671-10
CODE
Unit: 6102545
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on January 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-2672-10
CODE
Unit: 6106229
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on September 19, 2008. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-2675-10
CODE
Unit: 6107901 Parts 1 and Part 2
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated June 17, 2008. 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
TX
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-2676-10
CODE
Units: 040C 09986, 040C 09991, 040C 10002, 040C 10003, 040C 10004, 040C 10005, 040C 10006, 040C 10007, 040C 10008, 040C 10009, 040C 10010, 040C 10011, 040C 10012, 040C 10020, 040C 10021, 040C 10025, 040C 10026, 040C 10030, 040C 10039 and 040C 10042
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region, Peoria, IL, by fax on April 26, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2690-10
CODE
Unit: 1435926
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by fax on July 22, 2005. 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
FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2692-10
CODE
Unit: W020007107898
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Blood Bank, Bethesda, MD, by fax on August 6, 2008. 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
D.C.
___________________________________
PRODUCT
1) Cryoprecipitated AHF Pooled. Recall # B-2694-10;
2) Cryoprecipitated AHF. Recall # B-2695-10
CODE
1) Units: 040C10054, 040C10055, 040C10056, 040C10057, 040C10058, 040C10059, 040C10060, 040C10061, 040C10062, 040C10063, 040C10064, 040C10065, 040C10067, 040C10068, 040C10069, 040C10070, 040C10071, 040C10072, 040C10073, 040C10074, 040C10075, 040C10076, 040C10077, 040C10078, 040C10079, 040C10080, 040C10081, 040C10082, 040C10083, 040C10084, 040C10085, 040C10089, 040C10090, 040C10091, 040C10092, 040C10094, 040C10096, 040C10097, 040C10098, 040C10099, 040C10100, 040C10101, 040C10102, 040C10105, 040C10106, 040C10107, 040C10108, 040C10109, 040C10110, 040C10111, 040C10112, 040C10113, 040C10114, 040C10115, 040C10116, 040C10117, 040C10120, 040C10121, 040C10122, 040C10123, 040C10124, 040C10125, 040C10126, 040C10127, 040C10131, 040C10132, 040C10133, 040C10134, 040C10135, 040C10137, 040C10138, 040C10142, 040C10146, 040C10148, 040C10149, 040C10150, 040C10151, 040C10152, 040C10153, 040C10154, 040C10155, 040C10156, 040C10157, 040C10158, 040C10159, 040C10160, 040C10161, 040C10162, 040C10164, 040C10165;
2) 040GN29198, 040KL12465, 040LN32440, 040LN32443, 040GN29305, 040LN32420, 040LN32425, 040LN32451, 040LT42401, 040GN29297, 040KL12468, 040KL12471, 040KL12473, 040GJ77089, 040GJ77092, 040FH43986, 040FH44011, 040GJ77090, 040GJ77086, 040FH43985, 040FH43996, 040GF91469, 040LT42450, 040LX18994, 040GN29476, 040GN29477
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region, Peoria, IL, by facsimile on May 28, 2010 and June 6, 11, and 15, 2010. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum potency of antihemophilie factor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
IL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2698-10;
2) Fresh Frozen Plasma. Recall # B-2699-10;
3) Platelets Leukocytes Reduced. Recall # B-2700-10
CODE
1), and 3) Units: 019FS37640, 019LV47657;
2) Unit: 019FS37640
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter dated May 22, 2008 or by electronic notification on May 22, 2008. 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
5 Units
DISTRIBUTION
TN, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2701-10;
2) Plasma Frozen. Recall # B-2702-10
CODE
1) and 2) Unit: 019GG84026
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter dated May 16, 2008. 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
TN, KY
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2703-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2704-10
CODE
1) and 2) Unit: 19GQ23301
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on January 24, 2008 and by letter dated January 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2705-10;
2) Fresh Frozen Plasma. Recall # B-2706-10;
3) Platelets Leukocytes Reduced. Recall # B-2707-10
CODE
1). 2) and 3) Unit: 19LW55040
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter dated December 13, 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
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2708-10
CODE
Unit: 038GZ15275
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on July 19, 207 and by facsimile on July 20, 2007. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was not complete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
_____________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2718-10;
2) Recovered Plasma. Recall # B-2719-10
CODE
1) and 2) Unit: 1450736
FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated September 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was receiving methotrexate injections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, NJ
_____________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2720-10;
2) Plasma Frozen. Recall # B-2721-10
CODE
1) and 2) Unit: 49FE20668
FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Tulsa, OK, by telephone on October 29, 2008 and fax on October 30, 2008.
Manufacturer: American Red Cross, Wichita Falls, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, OK
_____________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2722-10;
2) Fresh Frozen Plasma. Recall # B-2723-10
CODE
1) and 2) Unit: 4384641
FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated April 18, 2007. 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
TX
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-2378-10
CODE
Unit: 53G83554
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on November 4, 2005 and letter dated November 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose hemoglobin was not recorded during screening, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Washed. Recall # B-2472-10
CODE
Units: 041FV72245, 041LR03415, 026FJ55860
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on July 14, 2008 and by follow-up letters on July 17, 2008, August 29, 2008 and October 6, 2008. Firm initiated recall is complete.
REASON
Blood products, which may not have been prepared in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2502-10
CODE
Unit: KF59856
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc, Milwaukee, WI, by facsimile on November 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2503-10
CODE
Unit: LY22290
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 22, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been shipped at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2507-10
CODE
Unit: 35Y85066
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Roanoke, VA, by telephone on October 5, 2007 followed by a letter dated November 8, 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
VA, CA
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-2512-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2513-10
CODE
1) Units: GJ13056, GM01731;
2) Units: LJ0459, GM01731
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on June 8, 2007. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2547-10
CODE
Units: 1447733; 1423369; 1424320; 1426377
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated July 25, 2006. Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-2551-10
CODE
Units: 6030188015; 6030187460; 6030187165
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by fax on June 7, 2006.
Manufacturer: ZLB Plasma, Corpus Christi, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2553-10
CODE
Unit: W053108200200
RECALLING FIRM/MANUFACTURER
Johnston Memorial Hospital Abingdon, VA, by letter dated September 22, 2008. 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
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-2645-10
CODE
Units: 6030246191; 6030244008; 6030228120; 6030224995; 6030224677; 6030223905; 6030223460; 6030220763; 6030219027; 6030217788
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Plasma, Boca Raton, FL, by fax on July 6, 2007.
Manufacturer: ZLB Plasma, Corpus Christi, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-2673-10
CODE
Units: 0200501734; 0200503842; 0200503941
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on September 3, 2008.
Manufacturer: CLS Plasma, Inc., Norman, OK. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-2674-10
CODE
Unit: 6108395
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on March 10, 2008. Firm initiated recall is complete.
REASON
Blood product, in which syphilis results were not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-2697-10
CODE
Unit: 019LV47657
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter dated May 22, 2008 or by electronic notification on May 22, 2008. 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
TN, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2709-10
CODE
Unit: 12GE00558
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on April 21, 2008 and by letter dated April 23, 2008. Firm initiated recall is complete.
REASON
Blood product, which was not labeled with a positive antibody identification tag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
_____________________________________
PRODUCT
Source Plasma. Recall # B-2714-10
CODE
Units: 4530190287; 4530188123; 4530187683; 4530186781; 4530186368
FIRM/MANUFACTURER
CSL Plasma Services, Inc., Melrose Park, IL, by e-mail on December 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL and Germany
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2724-10
CODE
Unit: W12007000517
RECALLING FIRM/MANUFACTURER
Department of the Army, US Army Blood Bank Center, Fort Hood, TX, by fax on March 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose hemoglobin was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I __________________________________
PRODUCT
1) BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. 510K # for Adult product: K934310: a) Part # 562013, Part # b) 562048, c) Part # 562133, d) Part # 562136. Recall # Z-2332-2010;
2) BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. 510K # for Child/Infant product: K940581 a) Part # 562080, b) Part # 562081, c) Part # 562082, d) Part # 562084, e) Part # 562086, f) Part # 562110, g) Part # 562111, h) Part # 32628, i) Part # 32629. Recall # Z-2333-2010
CODE
1) a) Lot # 47952, 48174, 48320, 48489, 48718, 48893, 49093, 49179, 49353, 49567, 49685, b) Lot # 47772, 47896, 47971, 47972, 48319, 48449, 48577, 48892, 48970, 49092, 49178, c) Lot # 48321, 49225 49407, d) Lot # 47728, 49094 4927;
2) a) Lot # 48719, 49144, b) Lot # 49643, 49660, c) Lot # 48091, 49274, 49386, 49487, d) Lot # 48119, 48578, 48733, 48941, 49042, 49254, e) Lot # 47895, 48071, 48488, 48823, f) Lot # 49489, g) Lot # 49611, 48276, h) Lot # 49273, 49273, 47834, i) Lot # 48140, 48141, 48428, 48142, 48275, 48652, 48429
RECALLING FIRM/MANUFACTURER
Westmed Inc., Tucson, AZ, by letter dated June 21, 2010. Firm initiated recall is ongoing.
REASON
This recall was initiated after Firm became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.
VOLUME OF PRODUCT IN COMMERCE
24879 (24384 in US)
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures. Recall # Z-2030-2010
CODE
Lot numbers: 0509537, 0509640, 509755, 0510102, 0511801, 0512206, 0512406, 0512528, 0516564, 0516805, 0517446, 0517447, 0518048, 0518149, 0518643, 0518701, 0519441, 0519442, 0519552, 0519553, 0520004, 0520005, 0520218, 0520219, 0520929, 0520930, 0523108, 0523109, 0523529, 0523629, 0525614, 0525615, 0525722, 0526317, 0526330, 0526518, 0526519, 0527001, 0529801, 0529802, 0529914, 0530028, 0530029, 0530101, 0530102, 0530103, 0530104, 0530105, 0530602, 0530707, 0530802, 0532125, 0532126, 0532127, 0532128, 0532630, 0532719, 0532735, 0532829, 0532904, 0532905, 0532907, 0533301, 0533335, 0533401, 0533421, 0533509, 0533537, 0533538, 0534017, 0534123, 0534124, 0534125, 0534126, 0534201, 0600501, 0600502, 0600931, 0600932, 0601119, 0601120, 0601333, 0601334, 0601601, 0601602, 0601703, 0602303, 0602304, 0603017, 0603018, 0603105, 0603205, 0603206, 0603207, 0604414, 0604415, 0605106, 0605107, 0605403, 0606601, 0607201, 0607202, 0607903, 0607904, 0608607, 0614210, 0623313, 0623606, 0623607, 0625412, 0625708, 0626201, 0626202, 0626203, 6036442, 6036670, 6109808, 6109921, 6109955, 6110083, 6138406, 6185510, 6197801, 6197828, 7004186, 7132081, 7146061, 7147793, 7147806, 7352981, 7451269, 7460608, 7479974, 7589735, 7639747, 7661223, 7681451, 7972937, 7979266, 8189696, 8277354, 8289638, 8306418, 8393857, 8521396, 8591790, 8629823, 8646480, 8675184, 8792196, 8898855, 9018451, 9036333, 9145329, 9156757, 9264475, 9323332, 9343587, 9381161, 9498440, 9498589, 9522139, 9569658, 9569711, 9598408, 9602041, 9603836, 9632400, 9685157, 9693616, 9695953, 9695961, 9695988, 9739629, 9739670, 9769262, 9779938, 9790387, 9790395, 9806955, 9806964, 9806969, 9806972, 9806974, 9807053, 9822530, 9855639, 9856396, 9861501, 9866062, 9867454, 9868936, 9872244, 9872246, 9879754, 9879755, 9880630, 9885376, 9886127, 9886150, 9889117, 9889118, 9896073, 9896079, 9898916, 9899409, 9905053, 9914662, 9914664, 9951987, 9953209, 9954653, 9955080, 9962340, 9964925, 9964932, 9964933, 9972391, 9972392, 9975062, 9979217, 9983473, 10002996, 10003686, 10014769, 10017111, 10026931, 10031165, 10032632, 10034838, 10036286, 10036287, 10044003, 10044004, 10044005, 10051493, 10053662, 10053663, 10053664, 10071125, 10071127, 10071130, 10076492, 10076493, 10076494, 10076495, 10087478, 10087479, 10087481, 10097088, 10097089, 10097090, 10103752, 10103753, 10112428, 10112429, 10112431, 10112432, 10120939, 10135522, 10135524, 10135526, 10135529, 10197760, 10197768, 10197776, 10197781, 10282249, 10282251, 10282252, 10282254, 10282255, 10296725, 10296728, 10307473, 10307474, 10315453, 10315454, 10315455, 10315456, 10325134, 10325135, 10335048, 10347695, 10347696, 10347698, 10347700, 10365897, 10365898, 10372654, 10372656, 10375862, 10375863, 10398877, 10398878, 10398879, 10398880, 10407000, 10428853, 10444975, 10446876, 10469219, 10472750, 10472751, 10475205, 10480924, 10480926, 10480927, 10485845, 10485846, 10485847, 10488358, 10495393, 10495394, 10495398, 10497009, 10500586, 10519438, 10527121, 10535508, 10535509, 10537711, 10541287, 10541288, 10561651, 10561652, 10561653, 10561654, 10561656, 10582159, 10582161, 10582163, 10587526, 10590657, 10590658, 10590660, 10590661, 10656233, 10656234, 10656235, 10656236, 10665853, 10665854, 10665855, 10671984, 10671991, 10675076, 10686976, 10686977, 10686978, 10686979, 10691192, 10691195, 10711510, 10806542, 10806546, 10806551
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therapy,
Brooklyn Park, MN, by letter dated April 2, 2010.
Manufacturer: Medtronic Mexico EG, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of the release mechanism during handling or deployment could result in the release of small components into the body.
VOLUME OF PRODUCT IN COMMERCE
22,946 (20,714 - Nationwide, 2,232 - Internationally)
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Venezuela
___________________________________
PRODUCT
Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile. The handpiece is inserted into the breast to the site of interest. When the proper location/position is achieved, the handpiece cuts and removes biopsy tissue. Recall # Z-2285-2010
CODE
Lot number: 00316
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Indianapolis, IN, by letters on August 11, 2010. Firm initiated recall is ongoing.
REASON
The firm received a customer complaint that the device labeled as ATEC 0912-12 was actually ATEC 0912-20.
VOLUME OF PRODUCT IN COMMERCE
990 units
DISTRIBUTION
Nationwide, Canada, Belgium, Algeria, Germany, London, Lebanon and Italy
___________________________________
PRODUCT
1) Versys Hip System Femoral Head 12/14 Taper 32 MM Dia. -3.5 MM Neck Length Zimaloy CO-CR-MO Alloy Sterile Qty-1. The VerSys Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty. VerSys Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-032-01. Recall # Z-2290-2010;
2) Versys Hip System Femoral Head 12/14 Taper 28 MM Dia. -3.5 MM Neck Length Zimaloy CO-CR-MO Alloy Sterile Qty-1. The VerSys Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty. VerSys Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-028-01. Recall Z-2291-2010
CODE
1) Lot number 61275855;
2) Lot number 61424803
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated July 9, 2010.
Manufacturer: Zimmer Manufacturing B.V., Meredita, PR. Firm initiated recall is complete.
REASON
Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect.
VOLUME OF PRODUCT IN COMMERCE
208 units
DISTRIBUTION
Nationwide, Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India
___________________________________
PRODUCT
1) Mitek VAPR S90 Suction Electrode (integrated) Product Code: 225370 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2297-2010;
2) Mitek VAPR S50 Knee Electrode (integrated) Product Code: 227355 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2298-2010;
3) Mitek VAPR Premiere50 Electrode (integrated) Product Code: 227504 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2299-2010;
4) Mitek VAPR Premiere 90 Electrode (integrated) Product Code: 227204 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2300-2010
5) Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2301-2010;
6) Mitek VAPR Flexible Side Effect Electrode (integrated) Product Code: 227312 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2302-2010;
7) Mitek VAPR Angled Side Effect Electrode (integrated) Product Code: 227302 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2303-2010;
8) Mitek VAPR Hook Electrode (integrated) Product Code: 227305 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2304-2010;
9) Mitek VAPR Side Effect Short Electrode (integrated) Product Code: 227211 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2305-2010;
10) Mitek VAPR End Effect Electrode (integrated) Product Code: 227202 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2306-2010;
11) Mitek VAPR Wedge Electrode (integrated Product Code: 227203 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2307-2010;
12) Mitek VAPR Wedge Short Electrode (integrated) Product Code: 227213 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2308-2010;
13) Mitek VAPR Temperature Control Electrode (integrated Product Code: 227252 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. Recall # Z-2309-2010
CODE
All lots of unexpired product
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated June 7, 2010.
Manufacturer: Gyrus Medical, Cardiff, UK. Firm initiated recall is ongoing.
REASON
Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility.
VOLUME OF PRODUCT IN COMMERCE
759.689 units (446,015 US and 313,674 internationally)
DISTRIBUTION
Nationwide, Canada, Argentina, Australia, Bahrain, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Portugal, Sweden, Switzerland, Syria, Thailand ,Turkey, UK, Ukraine, UAE, Venezuela, Vietnam, and Yemen
___________________________________
PRODUCT
1) NexGen complete knee solution MIS total knee procedure stemmed Tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2408-2010;
2) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2409-2010;
3) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2410-2010;
4) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2411-2010;
5) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2412-2010;
6) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2413-2010;
7) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2414-2010;
8) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2415-2010;
9) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4+ (Plus), sterile, REF 00-5950-037-12. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2416-2010;
10) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2417-2010;
11) NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. Recall # Z-2418-2010
CODE
1) Lot numbers: 103048, 7878946, 60242394, 60263535, 60282365, 60292619, 60292624, 60296116, 60302284, 60312266, 60317606, 60328157, 60331375, 60492607, 60548462, 60558662, 60582735, 60612398, 60625481, 60631130, 60662632, 60686881, 60711155, 60756483, 60805428, 60823401, 60895104, 60896872, 60959680, 60994894, 61050231, 61133857, 61158294, 61198698, 61248778, 61350333 and 61410286;
2) Lot numbers: 111131, 7881879, 60263536, 60282367, 60292618, 60292620, 60292623, 60296117, 60296118, 60296119, 60302285, 60312260, 60315642, 60317607, 60321945, 60328158, 60328161, 60331376, 60334521, 60362084, 60372785, 60372786, 60380755, 60457190, 60457195, 60460069, 60472448, 60476747, 60480951, 60492608, 60497690, 60502850, 60512205, 60518609, 60523102, 60538366, 60542934, 60554995, 60562933, 60566980, 60575470, 60578770, 60582736, 60593836, 60595803, 60608104, 60612399, 60616286, 60621119, 60625489, 60631132, 60634788, 60640822, 60649151, 60660341, 60667948, 60677455, 60682185, 60686882, 60692576, 60701924, 60711156, 60717978, 60732156, 60732158, 60748243, 60752980, 60760509, 60765124, 60775800, 60782863, 60785781, 60790429, 60801746, 60809057, 60816237, 60818763, 60823402, 60840790, 60847122, 60854122, 60867943, 60873473, 60881693, 60895096, 60895105, 60909839, 60917515, 60929865, 60929872, 60934274, 60942490, 60949438, 60949442, 60959681, 60967997, 60969509, 60979127, 60983699, 60987129, 60994895, 61006364, 61006366, 61022793, 61022794, 61029263, 61034993, 61045015, 61050232, 61057516, 61064204, 61090790, 61097029, 61100563, 61113637, 61116565, 61121501, 61128962, 61133865, 61138441, 61138448, 61149375, 61154238, 61158295, 61174187, 61181644, 61181648, 61193863, 61198699, 61211009, 61216067, 61225956, 61231012, 61245335, 61248779, 61253733, 61259044, 61259045, 61259059, 61262894, 61262895, 61262903, 61262904, 61262905, 61267824, 61267825, 61267843, 61272582, 61272598, 61277589, 61280559, 61280560, 61285875, 61285890, 61285892, 61289981, 61289994, 61295484, 61295485, 61298635, 61302107, 61302116, 61307076, 61307086, 61311098, 61315686, 61315687, 61319839, 61319850, 61324494, 61324506, 61324507, 61329234, 61334540, 61338267, 61338286, 61344102, 61344103, 61350284, 61350285, 61350286, 61355734, 61355735, 61355736, 61355743, 61355744, 61355745, 61360859, 61360860, 61365234, 61365248, 61370239, 61370249, 61370250, 61376578, 61376588, 61376589, 61380424, 61380425, 61380436, 61380437, 61380438, 61386637, 61386638, 61390830, 61390831, 61395038, 61395039, 61395040, 61399697, 61399698 and 61399699;
3) Lot numbers: 102857, 103992, 112386, 113494, 7878228, 7879513, 7879571, 7880358, 7881615, 7881898, 7883401, 60218034, 60218040, 60242847, 60249205, 60251625, 60251626, 60256223, 60256224, 60258856, 60258857, 60260762, 60260768, 60260769, 60264875, 60264883, 60267795, 60267796, 60267797, 60269817, 60269818, 60273902, 60273903, 60273904, 60273905, 60299527, 60299528, 60299536, 60302286, 60302287, 60307218, 60307219, 60307228, 60312267, 60315643, 60317608, 60317609, 60321946, 60321947, 60326184, 60326185, 60326186, 60328162, 60328163, 60331377, 60331378, 60331393, 60334522, 60334523, 60334524, 60336051, 60336052, 60336053, 60339640, 60339641, 60350411, 60350412, 60352909, 60352914, 60355704, 60355705, 60358828, 60358829, 60362082, 60362085, 60362086, 60362087, 60365649, 60365650, 60369191, 60369192, 60369193, 60369198, 60372787, 60372788, 60374326, 60374327, 60374328, 60374337, 60374338, 60380756, 60384324, 60457196, 60460070, 60463940, 60472449, 60476748, 60476749, 60476750, 60480948, 60480949, 60480950, 60485542, 60485543, 60485544, 60485545, 60492609, 60497691, 60497694, 60502851, 60509185, 60509186, 60509187, 60512206, 60518610, 60523103, 60523104, 60523105, 60526387, 60526388, 60526389, 60534170, 60534171, 60538367, 60538368, 60542935, 60542936, 60542937, 60542938, 60553222, 60553223, 60553224, 60553225, 60554996, 60554997, 60558663, 60558666, 60562934, 60562938, 60566977, 60566981, 60570897, 60570898, 60570901, 60570902, 60575471, 60575472, 60575473, 60578771, 60578772, 60582737, 60582738, 60584741, 60584749, 60593837, 60593838, 60593839, 60593840, 60595798, 60595804, 60599407, 60599408, 60599409, 60608105, 60608109, 60612401, 60612403, 60616287, 60621120, 60621121, 60621122, 60625482, 60625483, 60625490, 60627675, 60627684, 60631133, 60631134, 60631135, 60634789, 60634790, 60640823, 60640824, 60640825, 60644376, 60644377, 60649152, 60649159, 60649161, 60649162, 60660342, 60662633, 60662638, 60667949, 60667950, 60673744, 60673747, 60673748, 60677456, 60677457, 60682183, 60682186, 60686875, 60686876, 60686883, 60692577, 60696164, 60696166, 60696175, 60701925, 60701926, 60706409, 60706415, 60711157, 60711158, 60711162, 60717979, 60717980, 60717987, 60722693, 60722700, 60727485, 60727486, 60727487, 60732161, 60732162, 60748244, 60748246, 60748247, 60752981, 60756484, 60756485, 60760510, 60760511, 60765122, 60765125, 60765126, 60770655, 60770656, 60775804, 60775805, 60782864, 60782865, 60782873, 60785782, 60785783, 60790430, 60790431, 60795415, 60795416, 60795417, 60801747, 60801748, 60801749, 60805431, 60809058, 60809059, 60816235, 60816238, 60818764, 60818765, 60818768, 60823403, 60823404, 60831898, 60831904, 60836380, 60840791, 60845498, 60845499, 60845501, 60845502, 60847123, 60854123, 60854124, 60854125, 60854130, 60854131, 60873474, 60873475, 60873476, 60881694, 60881695, 60881696, 60881704, 60895097, 60895098, 60895106, 60895107, 60895108, 60902930, 60902931, 60902932, 60902933, 60909842, 60909845, 60909848, 60909851, 60917510, 60923129, 60923130, 60923133, 60923134, 60923135, 60923136, 60929866, 60929867, 60929873, 60934275, 60934280, 60934281, 60942491, 60942494, 60949439, 60949443, 60949444, 60955226, 60955227, 60955234, 60955235, 60959682, 60959688, 60968000, 60968001, 60968010, 60968011, 60969510, 60969511, 60979128, 60979129, 60979130, 60983701, 60983702, 60983708, 60987130, 60987131, 60987135, 60994896, 60994902, 60994904, 61000887, 61000888, 61000889, 61006367, 61006368, 61013835, 61013836, 61013841, 61018483, 61018484, 61022795, 61022801, 61029264, 61029267, 61029268, 61034999, 61035001, 61035002, 61035007, 61045016, 61045019, 61045020, 61050233, 61050238, 61057517, 61057522, 61057523, 61064205, 61064206, 61090791, 61090792, 61090793, 61097030, 61097031, 61097032, 61100564, 61100565, 61100573, 61105889, 61105890, 61105896, 61113638, 61113642, 61113643, 61113644, 61121502, 61121503, 61121504, 61128964, 61128965, 61128966, 61133858, 61133859, 61133866, 61133870, 61133871, 61138449, 61149370, 61149372, 61154230, 61158296, 61158297, 61158298, 61158299, 61164691, 61164692, 61164696, 61170876, 61170877, 61170878, 61174188, 61174189, 61174192, 61174193, 61181645, 61181649, 61181650, 61181651, 61187786, 61193864, 61193865, 61193866, 61198694, 61198695, 61204958, 61204959, 61204966, 61211003, 61211004, 61211010, 61211011, 61216060, 61221202, 61221207, 61221208, 61221209, 61225954, 61225957, 61225958, 61231006, 61231007, 61235896, 61235897, 61235898, 61235904, 61235905, 61240546, 61240550, 61240551, 61245331, 61245336, 61245337, 61245338, 61248780, 61253724, 61253725, 61253734, 61253735, 61253736, 61253737, 61253738, 61253739, 61259046, 61259047, 61259048, 61259049, 61262897, 61262906, 61262908, 61262909, 61262910, 61262911, 61267826, 61267827, 61267828, 61267829, 61272583, 61272584, 61272585, 61272586, 61272587, 61272601, 61272602, 61272603, 61272604, 61277573, 61277590, 61277591, 61277592, 61280555, 61280561, 61280562, 61280563, 61280564, 61280565, 61280566, 61285876, 61285877, 61285878, 61285879, 61285880, 61285893, 61285894, 61285895, 61285896, 61285897, 61289982, 61289995, 61289996, 61289997, 61289998, 61289999, 61290001, 61295486, 61295487, 61295488, 61295489, 61295490, 61295491, 61298636, 61298637, 61298638, 61298639, 61298640, 61302108, 61302109, 61302110, 61302117, 61302118, 61302119, 61302120, 61302121, 61302122, 61307085, 61307087, 61307088, 61307089, 61307090, 61311099, 61311100, 61311101, 61311102, 61311103, 61315688, 61315690, 61315691, 61315692, 61315693, 61315694, 61319840, 61319851, 61319852, 61319853, 61319854, 61324495, 61324496, 61324497, 61324508, 61324509, 61324510, 61324511, 61324512, 61329241, 61329242, 61329243, 61329244, 61329246, 61334543, 61334544, 61334545, 61334546, 61334548, 61338268, 61338269, 61338270, 61338271, 61338272, 61338273, 61344104, 61344105, 61344106, 61344107, 61344108, 61344109, 61344110, 61344111, 61350312, 61350313, 61350314, 61350315, 61350316, 61350317, 61350318, 61350319, 61355737, 61355738, 61355739, 61355746, 61355747, 61355748, 61355749, 61355750, 61360848, 61360849, 61360861, 61360862, 61360863, 61360864, 61360865, 61365235, 61365236, 61365237, 61365238, 61365249, 61365250, 61365251, 61370240, 61370241, 61370247, 61370251, 61370252, 61370253, 61376579, 61376580, 61376581, 61376590, 61376591, 61376592, 61380426, 61380439, 61380440, 61380441, 61380442, 61386641, 61386642, 61386643, 61386644, 61386645, 61386646, 61390838, 61390839, 61390840, 61390841, 61390842, 61395047, 61410276, 61410277, 61410278, 61410280, 61410281, 61412370, 61412371, 61412372, 61412373 and 61412374;
4) Lot numbers: 109168, 7878944, 7879126, 7879570, 7879652, 7879676, 7883382, 7883854, 60218033, 60232198, 60237941, 60242848, 60249206, 60251627, 60251629, 60256225, 60256226, 60258858, 60258859, 60258860, 60258865, 60260763, 60260764, 60260770, 60264876, 60264877, 60264884, 60264886, 60267798, 60267799, 60269819, 60269820, 60273906, 60273907, 60296120, 60296121, 60299529, 60299530, 60299531, 60302288, 60302289, 60307220, 60307221, 60307222, 60312261, 60312262, 60312268, 60315644, 60315645, 60317610, 60317616, 60321948, 60321949, 60321950, 60326187, 60326188, 60328164, 60331379, 60331380, 60331381, 60334525, 60334526, 60334527, 60334528, 60336054, 60336055, 60336056, 60339642, 60339643, 60350413, 60352910, 60352911, 60352915, 60355706, 60355707, 60355708, 60358830, 60358831, 60358832, 60362088, 60362089, 60362090, 60365651, 60365652, 60365653, 60369194, 60369195, 60369199, 60372789, 60372790, 60374324, 60374329, 60374330, 60374331, 60374339, 60374340, 60380757, 60380758, 60384325, 60490383, 60490384, 60492610, 60497692, 60497695, 60502852, 60509188, 60512207, 60518611, 60518612, 60523106, 60526390, 60528085, 60528086, 60534172, 60534173, 60538369, 60538370, 60538371, 60542939, 60542940, 60548467, 60548468, 60548469, 60548470, 60554998, 60554999, 60555001, 60555002, 60558667, 60562935, 60562939, 60566978, 60566982, 60570903, 60570904, 60575474, 60575475, 60578773, 60582739, 60582740, 60582741, 60584742, 60584750, 60593841, 60593842, 60593843, 60595805, 60599410, 60599411, 60599412, 60599415, 60608110, 60616288, 60616289, 60621123, 60621124, 60625484, 60627676, 60627677, 60627685, 60631136, 60634791, 60634792, 60640826, 60640827, 60640828, 60644378, 60644379, 60649153, 60649160, 60649163, 60660343, 60662639, 60667951, 60673745, 60673749, 60673750, 60677458, 60677460, 60682187, 60686877, 60686878, 60692578, 60692579, 60696167, 60696168, 60696169, 60701927, 60701928, 60706411, 60706416, 60711159, 60717982, 60717983, 60717984, 60722694, 60722695, 60722701, 60727488, 60727489, 60727490, 60732163, 60748248, 60748249, 60752975, 60752982, 60756486, 60756490, 60760512, 60765123, 60765127, 60770653, 60770657, 60775801, 60775806, 60782866, 60782867, 60785784, 60785785, 60785786, 60790432, 60795418, 60795419, 60795420, 60801750, 60805432, 60809060, 60816236, 60816239, 60816240, 60818769, 60823405, 60831899, 60836381, 60836382, 60840792, 60840793, 60847124, 60854118, 60854126, 60854127, 60854132, 60854133, 60873477, 60881690, 60881697, 60881698, 60895099, 60895101, 60895109, 60895110, 60902934, 60902935, 60902936, 60909853, 60917511, 60923131, 60929868, 60929869, 60929874, 60934282, 60942492, 60942495, 60949440, 60949441, 60949445, 60955228, 60959683, 60959684, 60959689, 60968012, 60969513, 60969515, 60979131, 60979132, 60983703, 60983704, 60987132, 60987136, 60994897, 60994898, 61000883, 61000890, 61000891, 61006369, 61013837, 61013838, 61018485, 61018486, 61022802, 61029265, 61029269, 61035003, 61035004, 61035008, 61045017, 61045021, 61050234, 61057518, 61057519, 61064207, 61064208, 61090794, 61090795, 61097033, 61097034, 61100566, 61100567, 61100574, 61105891, 61105897, 61113639, 61113645, 61113646, 61116566, 61121505, 61121506, 61128967, 61128968, 61133861, 61138439, 61138442, 61138443, 61154231, 61154232, 61154233, 61158301, 61158302, 61158303, 61170875, 61170879, 61170880, 61174194, 61174195, 61174196, 61181646, 61181647, 61187787, 61187788, 61193867, 61193868, 61193869, 61204960, 61204961, 61211005, 61211006, 61216059, 61216061, 61216062, 61221205, 61221210, 61221211, 61225959, 61225960, 61231008, 61235899, 61235901, 61240547, 61240553, 61240554, 61245334, 61245339, 61248772, 61253726, 61253727, 61253728, 61253740, 61253741, 61259038, 61259050, 61259051, 61259052, 61262912, 61262913, 61262914, 61267831, 61267832, 61267833, 61272589, 61272591, 61272592, 61277576, 61277579, 61277581, 61277593, 61277594, 61280567, 61280568, 61280569, 61280570, 61285881, 61285882, 61285883, 61285884, 61289979, 61289983, 61289984, 61289985, 61289986, 61295477, 61295478, 61295479, 61295492, 61295493, 61295494, 61295495, 61298641, 61298642, 61298643, 61298644, 61302111, 61302112, 61302113, 61302123, 61302124, 61307077, 61307078, 61307091, 61307092, 61307093, 61307094, 61311104, 61311105, 61311106, 61311107, 61315695, 61315696, 61315697, 61315698, 61319841, 61319842, 61319843, 61319855, 61319856, 61319857, 61324498, 61324499, 61329235, 61329236, 61329237, 61329238, 61329239, 61329240, 61334549, 61334550, 61334551, 61334552, 61338275, 61338277, 61338278, 61338280, 61344113, 61344114, 61344115, 61344116, 61344117, 61344118, 61350325, 61350326, 61350327, 61350328, 61350329, 61350330, 61355751, 61355752, 61360850, 61360851, 61360852, 61360853, 61360866, 61365239, 61365240, 61365241, 61365242, 61365252, 61370242, 61370243, 61370248, 61370254, 61376582, 61376583, 61376593, 61376594, 61380427, 61380428, 61380429, 61386654, 61386655, 61386656, 61386657, 61386658, 61390834, 61390835, 61390836, 61390837, 61397690, 61397691, 61397692, 61399708, 61399709, 61410282, 61410283, 61410284, 61410285, 61412375 and 61412376;
5) Lot numbers: 103594, 106289, 106292, 111085, 7878942, 7878943, 7879193, 7879545, 7883402, 7885282, 60218032, 60232197, 60237944, 60242849, 60251630, 60251631, 60256227, 60256228, 60258861, 60258862, 60258866, 60260765, 60260766, 60260771, 60264878, 60264879, 60264885, 60264887, 60267801, 60269821, 60269822, 60269823, 60273908, 60273909, 60296122, 60299532, 60299533, 60299537, 60302290, 60302291, 60307223, 60312263, 60312264, 60315646, 60315647, 60315648, 60317611, 60321952, 60321953, 60326189, 60326190, 60328165, 60328166, 60328167, 60331394, 60334529, 60334530, 60336057, 60336058, 60336059, 60339644, 60339645, 60350414, 60352912, 60352916, 60355709, 60355710, 60358833, 60358834, 60362091, 60362092, 60365654, 60365655, 60366475, 60369196, 60369200, 60372791, 60374332, 60374333, 60374334, 60374341, 60380759, 60380760, 60384326, 60492611, 60497693, 60502853, 60509189, 60512208, 60518613, 60526391, 60526392, 60528087, 60534174, 60538372, 60538373, 60542941, 60548471, 60553226, 60553227, 60553228, 60553229, 60555003, 60558664, 60558665, 60562937, 60562940, 60566979, 60566983, 60570905, 60575476, 60578774, 60578775, 60582742, 60584743, 60584744, 60584751, 60593844, 60595801, 60595802, 60595806, 60599413, 60608106, 60612404, 60616290, 60621127, 60621128, 60625485, 60627678, 60627686, 60631137, 60631138, 60634793, 60634794, 60644380, 60644381, 60649155, 60649156, 60649165, 60660344, 60660345, 60662640, 60662641, 60667952, 60673751, 60677461, 60682188, 60686879, 60692580, 60692581, 60696171, 60701929, 60701930, 60706412, 60706417, 60711160, 60717985, 60722696, 60722697, 60727491, 60727492, 60732164, 60732165, 60748250, 60752976, 60756487, 60760513, 60760514, 60765128, 60770658, 60775803, 60775807, 60782868, 60782869, 60790428, 60790433, 60790434, 60801751, 60801752, 60805433, 60809062, 60816241, 60823407, 60831902, 60831903, 60836383, 60840794, 60847125, 60847126, 60854119, 60854128, 60854134, 60854135, 60873478, 60873479, 60881701, 60881702, 60895102, 60895111, 60895112, 60902937, 60909855, 60917512, 60923132, 60929870, 60934276, 60934283, 60942493, 60942496, 60955229, 60955230, 60959685, 60968002, 60968003, 60968013, 60969516, 60979133, 60979134, 60983705, 60987133, 60987137, 61000884, 61000892, 61006371, 61006372, 61013839, 61018487, 61018488, 61022803, 61034994, 61034995, 61035005, 61045018, 61050235, 61057520, 61064210, 61064211, 61090796, 61097036, 61097037, 61100568, 61100570, 61105892, 61105893, 61105898, 61116568, 61116569, 61116570, 61121507, 61121508, 61128970, 61128971, 61128972, 61133863, 61138440, 61138444, 61138445, 61154234, 61154235, 61164689, 61164694, 61164695, 61170882, 61170883, 61174197, 61174198, 61187790, 61187791, 61193870, 61198696, 61204962, 61204963, 61211008, 61216063, 61216064, 61221206, 61221212, 61231009, 61231010, 61235902, 61245332, 61248774, 61248775, 61253723, 61253729, 61253730, 61253731, 61259039, 61259040, 61259041, 61259053, 61259054, 61259061, 61262898, 61262916, 61262918, 61267820, 61267835, 61267836, 61267837, 61272593, 61272594, 61277583, 61277584, 61277585, 61277595, 61280556, 61280557, 61280571, 61280572, 61280573, 61285886, 61285887, 61289980, 61289988, 61289989, 61289990, 61289991, 61295480, 61295481, 61295496, 61295497, 61295498, 61295499, 61298645, 61298646, 61298647, 61307079, 61307080, 61307081, 61307095, 61311093, 61311094, 61311109, 61311110, 61311111, 61315699, 61315701, 61315702, 61319844, 61319845, 61319846, 61319858, 61324492, 61324502, 61324503, 61329247, 61329248, 61329249, 61329250, 61334554, 61334555, 61334556, 61338281, 61338282, 61338283, 61344119, 61344120, 61344121, 61350338, 61355740, 61360854, 61360855, 61360856, 61365243, 61365244, 61365245, 61370237, 61370244, 61370245, 61376577, 61376584, 61376585, 61380423, 61380430, 61380431, 61380432, 61386649, 61386650, 61386651, 61386652, 61386653, 61395045, 61395046, 61397693, 61397694 and 61412377;
6) Lot numbers: 102316, 103589, 105229, 111084, 111117, 111132, 114008, 7879168, 60218031, 60232196, 60238701, 60251632, 60251633, 60256229, 60258863, 60258864, 60260767, 60264880, 60264881, 60264888, 60267802, 60267803, 60267804, 60269824, 60269825, 60273910, 60273911, 60299534, 60299535, 60302292, 60302293, 60307224, 60307225, 60312265, 60315649, 60317612, 60317613, 60321954, 60326191, 60326192, 60331383, 60331384, 60331385, 60334531, 60334532, 60336060, 60339646, 60339647, 60350415, 60352917, 60355711, 60355712, 60358835, 60362093, 60365656, 60365657, 60372792, 60374325, 60374335, 60380761, 60380762, 60380763, 60384327, 60393079, 60490385, 60492612, 60502854, 60512209, 60518614, 60528088, 60528089, 60548472, 60548473, 60553230, 60555004, 60555005, 60558668, 60562941, 60570906, 60575477, 60578776, 60582743, 60584745, 60584752, 60595807, 60599414, 60608107, 60612405, 60621129, 60625486, 60627679, 60627680, 60631140, 60634795, 60634796, 60644382, 60649157, 60662636, 60667953, 60677462, 60682189, 60692574, 60692582, 60701931, 60706413, 60711161, 60722698, 60748251, 60752977, 60752978, 60756488, 60760515, 60765129, 60770659, 60782870, 60782871, 60790435, 60805429, 60805434, 60809063, 60818766, 60823408, 60836384, 60840795, 60854120, 60854129, 60867944, 60881691, 60881703, 60895103, 60895113, 60895114, 60917513, 60917516, 60929871, 60934277, 60934284, 60942497, 60955231, 60959686, 60968004, 60969502, 60969517, 60983706, 60994899, 61000885, 61006373, 61013840, 61018489, 61034996, 61035006, 61050236, 61057521, 61097038, 61100571, 61105894, 61113640, 61116571, 61121509, 61128973, 61128974, 61138446, 61154236, 61164690, 61164693, 61174186, 61174199, 61187792, 61198692, 61198697, 61204964, 61216065, 61225955, 61231005, 61235903, 61248776, 61253732, 61259042, 61259055, 61259056, 61262899, 61262901, 61262902, 61267821, 61267822, 61267823, 61267838, 61267839, 61267840, 61272596, 61277586, 61277587, 61280554, 61280558, 61280574, 61280575, 61285888, 61289992, 61295482, 61298632, 61298633, 61302105, 61302114, 61307082, 61307083, 61311095, 61311096, 61311112, 61315703, 61315704, 61319847, 61319848, 61324493, 61324504, 61329251, 61329252, 61329253, 61334563, 61334564, 61355741, 61355742, 61360857, 61360858, 61365246, 61365247, 61370255, 61370256, 61376586, 61376596, 61380433, 61380434, 61386647, 61386648, 61395041, 61395042, 61397695, 61399701, 61399702, 61412378, 61412379, 61412380, 61412381, 60732I59 and 61198692R;
7) Lot numbers: 7879512, 60145288, 60145289, 60158525, 60181456, 60207443, 60218022, 60218030, 60232193, 60251634, 60251636, 60264882, 60267805, 60269826, 60269827, 60273912, 60273913, 60302294, 60307226, 60315650, 60317615, 60326193, 60331386, 60331387, 60334533, 60334534, 60339648, 60339649, 60339650, 60347587, 60347588, 60347589, 60350406, 60350407, 60350408, 60350409, 60350416, 60352913, 60352918, 60358836, 60358837, 60369197, 60372793, 60374336, 60384328, 60467851, 60490386, 60502855, 60509190, 60512210, 60523107, 60528090, 60548474, 60553231, 60558669, 60566984, 60575478, 60578777, 60584746, 60584753, 60608108, 60612402, 60616291, 60625487, 60627681, 60631141, 60634797, 60644383, 60649158, 60682184, 60686880, 60696172, 60701932, 60717986, 60722699, 60752979, 60756489, 60770654, 60770660, 60782872, 60790436, 60805430, 60809064, 60823409, 60836385, 60847127, 60854121, 60867945, 60881692, 60895115, 60895116, 60909856, 60917517, 60923138, 60934278, 60942498, 60959687, 60969504, 60969518, 60987134, 60994901, 61006374, 61022796, 61034998, 61050237, 61090797, 61097039, 61105895, 61116572, 61116573, 61133856, 61133864, 61138447, 61143802, 61154237, 61174201, 61187793, 61198693, 61204965, 61216066, 61231004, 61231011, 61245333, 61248777, 61259057, 61259058, 61267841, 61267842, 61272597, 61277588, 61285874, 61285889, 61289993, 61295483, 61298634, 61302106, 61302115, 61307084, 61311097, 61315685, 61315705, 61315706, 61319849, 61324505, 61334559, 61334560, 61338266, 61338284, 61360847, 61365233, 61370238, 61370246, 61376587, 61380435, 61386639, 61386640, 61390833, 61395044, 61399704 and 61399705;
8) Lot numbers: 103044, 60276808, 60282368, 60292625, 60296123, 60296124, 60307227, 60315651, 60328159, 60331388, 60331389, 60339651, 60343929, 60343930, 60343931, 60343932, 60343933, 60343934, 60343935, 60355713, 60362083, 60365658, 60384329, 60534175, 60570899, 60578778, 60584754, 60616292, 60625488, 60640829, 60692575, 60727493, 60760516, 60818767, 60867946, 60892877, 60917518, 60955232, 60983707, 61113641 and 61143803;
9) Lot numbers: 60284257, 60331382, 60467849, 60621126, 60649154, 60732157, 60775802, 60923137, 61006365 and 61029266;
10) Lot numbers: 103572, 60282369, 60292621, 60296125, 60296126, 60312269, 60331390, 60895117 and 61116574;
11) Lot numbers: 103105, 104265, 7881970, 60276810, 60292622, 60296127, 60296128, 60312270, 60505320, 60505321, 60505323 and 60892882
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated April 26, 2010. Firm initiated recall is ongoing.
REASON
The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.
VOLUME OF PRODUCT IN COMMERCE
68,384
DISTRIBUTION
AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, WI, and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand
___________________________________
PRODUCT
1) Fabius GS Anesthesia Machine, OR/Anesthesia, inhalation anesthesia machine for use in operating, induction and recovery rooms. Catalog #8604699. Recall # Z-2478-2010;
2) Fabius Tiro Anesthesia Machine, OR/Anesthesia. Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required. Catalog #8606000. Recall # Z-2479-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Medical Systems, Inc., Telford, PA, by letter dated August 2010. Firm initiated recall is ongoing.
REASON
Potential failures to Electri-Cord Manufacturing AC power cord.
VOLUME OF PRODUCT IN COMMERCE
203 power cords
DISTRIBUTION
Nationwide, Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela
___________________________________
PRODUCT
SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure). The implant holder is used to place the implant into the vertebral disc space. Catalog #03.802.039. Recall # Z-2583-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, letter dated August 20, 2010. Firm initiated recall is ongoing.
REASON
A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore
___________________________________
PRODUCT
Weck IMA/ENT Blade Electrode � (1.9 cm), REF 809335, Rx Only Sterile. The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation are in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed. Recall # Z-2584-2010
CODE
Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by letter dated July 30, 2010.
Manufacturer: Teleflex Medical, Tecate, Mexico. Firm initiated recall is ongoing.
REASON
Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.
VOLUME OF PRODUCT IN COMMERCE
190,344 units (131,448 Nationwide & 58,896 Internationally)
DISTRIBUTION
Nationwide, Canada, Australia and Singapore.
___________________________________
PRODUCT
Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties. Recall # Z-2487-2010
CODE
All products
RECALLING FIRM/MANUFACTURER
Wally’s Natural Products, Auburn, CA, by telephone, letter and website beginning February 17, 2010. Firm initiated recall is ongoing.
REASON
Product is an unapproved medical device. Use as directed may result in accidental damage to the eardrum, leading to injuries up to loss of hearing.
VOLUME OF PRODUCT IN COMMERCE
Unknown (All products)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. Recall # Z-2589-2010
CODE
Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190
RECALLING FIRM/MANUFACTURER
Organogenesis, Inc., Canton, MA, by telephone, e-mail or fax on August 2, 2010. Firm initiated recall is complete.
REASON
Product is contaminated with yeast identified as Pseudozyma Antarctica.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
AL, AZ, CA, CO, IL, NC, PA, TN, and VA
___________________________________
PRODUCT
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Recall # Z-2590-2010
CODE
Serial Number 2760
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter, dated March 25, 2010. Firm initiated recall is ongoing.
REASON
Product may exhibit issues with stat sample rack loading, causing a possible delay in results.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
CA, IN, GA, NC, OH, SC, and WI
___________________________________
PRODUCT
1) Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350. Delivers controlled amounts of medication and narcotics. Recall # Z-2591-2010;
2) Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments. Delivers controlled amounts of medication and narcotics. Recall # Z-2592-2010;
3) Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-100. Delivers controlled amounts of medication and narcotics. Recall # Z-2593-2010;
4) Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use, REF 575-100S1. Delivers controlled amounts of medication and narcotics. Recall # Z-2594-2010
CODE
1) Lot #’s: '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, '10039022, '10040012, '10152022, '10153012, '10188012, and '10203012;
2) Lot #’s: '09232012, '10112032, '09238012, '10113012, '09246012, '10116022, '09259012, '10117012, '09266012, '10118012, '09280012, '10119012, '09287012, '10120012, '09300012, '10123022, '09303012, '10124012, '10005012, '10153012, '10007012, '10154012, '10008012, '10155012, '10011012, '10158022, '10047012, '10159012, '10048012, '10160012, '10049012, '10161012, '10050012, '10162012, '10074022, '10165022, '10076012, '10166012, '10077012, '10167012, '10078012, '10167022, '10081022, '10168012, '10102022, '10169012, '10103012, '10170012, '10104012, '10172022, '10105012, '10173012, '10106012, '10174012, '10109022, '10175012, '10110012, '10176012, '10111022, and '10177012;
3) Lot #’s: '09231012, '09233012, '09236022, '09237012, '09239022, '09243022, '09244012, '09245012, '09247012, '09252022, '09253012, '09254012, '09257022, '09260012, '09261012, '09264022, '09265012, '09268012, '09268022, '09271022, '09274012, '09275012, '09278022, '09279012, '09281012, '09282012, '09285022, '09286012, '09287012, '09288012, '09294012, '09295012, '09296012, '09299022, '09300012, '09302012, '09303012, '09306022, '09307012, '09343022, '09344012, '09345012, '09346012, '09348022, '09349012, '09350012, '09351012, '09352012, '09355012, '09356012, '09357012, '09362012, '09363012, '09364012, '10004022, '10005012, '10008012, '10011022, '10012012, '10013012, '10015012, '10019012, '10020012, '10021012, '10022012, '10025012, '10026012, '10027012, '10028012, '10041022, '10042012, '10043022, '10048012, '10049012, '10053022, and '10054022;
4) Lot #’s: 09237012, 09301012, 10040012, and 10049012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letters dated July 12, 2010 and September 1, 2010.
Manufacturer: Stryker Puerto Rico, LTD, Arroyo, PR. Firm initiated recall is ongoing.
REASON
All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors.
VOLUME OF PRODUCT IN COMMERCE
54,568 units
DISTRIBUTION
Nationwide, Canada, and Australia
_____________________________________
PRODUCT
1) Hemostatix Handle, for use with Models 150 and 600D Hemostatix Controllers, REF 7013-5050, Qty (1), Sterile EO. The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. Recall # Z-2595-2010;
2) Model P8400 Handle with Integrated Cable, for use with Model P8400 Controller, REF 7013-8050, Qty (1), Sterile EO. The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. Recall # Z-2596-2010
CODE
1) Lots: HMT0664, HMT0661, HMT0656
2) Lot: HMT0647
RECALLING FIRM/MANUFACTURER
Hemostatix Medical Technologies LLC, Bartlett, TN, by fax on July 27, 2010 and by letter dated July 29, 2010, and e-mail on July 30, 2010 and by telephone. Firm initiated recall is complete.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
259 units
DISTRIBUTION
CA, GA, LA, MA, MD, MO, NC, OH, OR, PA, SC, TX, VA, WI, Japan and Italy
_____________________________________
PRODUCT
1) Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375. Recall # Z-2610-2010;
2) Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720. Recall # Z-2611-2010;
3) Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501. Recall # Z-2612-2010;
4) Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010. Recall # Z-2613-2010;
5) Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552. Recall # Z-2614-2010;
6) Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03. Recall # Z-2615-2010;
7) Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485. Recall # Z-2616-2010;
8) Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03. Recall # Z-2617-2010
CODE
1) Lot numbers: MD15, MD15A, MD22, MD29, MD29A, ME19, and ME26A;
2) Lot numbers: MD15, MD15A, MD15B, MD22, ME19, and ME26;
3) Lot numbers: MD22 MD29 ME19;
4) Lot numbers: MD22, and ME19;
5) Lot numbers: MD22, ME19, ME26, MF03, and MF03A;
6) Lot numbers: MD15, and MD26;
7) Lot number: MD29;
8) Lot number: ME19
FIRM/MANUFACTURER
Terumo Cardiovascular Corp., Elkton, MD, by telephone, fax, email and letter on June 8, 2010 and by letter on June 9, 2010. Firm initiated recall is ongoing.
REASON
Medical device vent port may be occluded and prevent delivery of priming fluid.
VOLUME OF PRODUCT IN COMMERCE
3,979 units
DISTRIBUTION
Nationwide
_____________________________________
PRODUCT
1) Jazzy Select with XLR Port Harness. Recall # Z-2618-2010;
2) Jazzy Select 6 with XLR Port Harness. Recall # Z-2619-2010
CODE
All serial numbers
FIRM/MANUFACTURER
Pride Mobility Products, Corp., Exeter, PA, by letter on February 1, 2010. Firm initiated recall is ongoing.
REASON
Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.
VOLUME OF PRODUCT IN COMMERCE
100,636 units
DISTRIBUTION
Nationwide, Canada, Australia and UK
_____________________________________
PRODUCT
1) Access Immunoassay Systems PROGESTERONE, Part number: 33550. Recall # Z-2620-2010;
2) Access Immunoassay Systems CORTISOL, Part number: 33600. Recall # Z-2621-2010
CODE
1) Lot numbers: 913013 and 914457;
2) Lot number: 913550
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on the week of February 15, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of IND flags.
VOLUME OF PRODUCT IN COMMERCE
13,694 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000. Recall # Z-2622-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letter dated June 21, 2010, Firm initiated recall is ongoing.
REASON
Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
VOLUME OF PRODUCT IN COMMERCE
191,855 units
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, Chile, China, France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polkas, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
___________________________________
PRODUCT
1) Philips M3002A IntelliVue X2 Model: 865039 indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. Recall # Z-2625-2010;
2) Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. Recall # Z-2626-2010
CODE
1) Serial number range: DE83629383 – DE95052110;
2) Serial number range: DE83604981 – DE95008299
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare, Inc., Andover, MA, by letter dated August 26, 2010.
Manufacturer: Philips Medizin Systems Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.
REASON
Speakers on the Philips IntelliVue X2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
VOLUME OF PRODUCT IN COMMERCE
22,813 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 12640-01. Recall # Z-2627-2010;
2) Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 13261-01. Recall # Z-2628-2010;
3) Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 13263-01. Recall # Z-2629-2010;
4) Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 13273-01. Recall # Z-2630-2010;
5) Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V. Secure Lock and Non-DEHP, 59 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 19680-28 Recall # Z-2631-2010;
6) Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, 3 inch Segment of Clear PVC Tubing, 0.2 Micron Filter, Clave Port-SL, Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 20634-01. Recall # Z-2632-2010;
7) Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Anti-Siphon Valve, Pump Yellow Striped Tubing-SL, 95 inch; Rx, sterile, 24 individually packaged sets per case; Made in Costa Rica; list number 20635-01. Recall # Z-2633-2010
CODE
1) Lot numbers: 682105H and 770815H;
2) Lot numbers 691805H, 670695H, 760665H and 772085H;
3) Lot number; 682095H;
4) Lot numbers 680295H and 770875H;
5) Lot number 772075H;
6) Lot number: 682085H;
7) Lot numbers: 691825H, 701295H and 781565H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated August 12, 2010.
Manufacturer: Hospira Holdings de, Costa Rica, LTD, La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
Under delivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
VOLUME OF PRODUCT IN COMMERCE
340,824 sets
DISTRIBUTION
Nationwide, Canada, Costa Rica and Taiwan
___________________________________
PRODUCT
Enseal� TRIO Product Code ETRIO335H. Recall # Z-2635-2010
CODE
Lot number: G4TC14, Exp. Date 2012/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter dated July 19, 2010.
Manufacturer: Ethicon Endo Sirgery Inc Sa De, Lote Bravo Cuidad Juar, Mexico. Firm initiated recall is ongoing.
REASON
The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.
VOLUME OF PRODUCT IN COMMERCE
396 instruments
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041. Product is a Shoulder Instrument used to place the Glenoid Head Trail onto the Baseplate. Recall # Z-2636-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by letter dated July 12, 2010. Firm initiated recall is ongoing.
REASON
Complaints indicate product’s distal threaded tip may fracture under certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
104 units
DISTRIBUTION
Nationwide, PR, Germany, and Saudi Arabia
___________________________________
PRODUCT
1) Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1: Latex Free, Rx only. Recall # Z-2637-2010;
2) Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx only. Recall # Z-2638-2010
CODE
1) Serial numbers: NXT1001-1079, NLB0901901IE, NBL0902101IE, NBL0902501IE, NBA1000501IE, NBC1001501IE, NBC1002001IE, NBC1002301IE, NBC1002901IE, NBE1001301IE, NCE1001901IE, NBF1000701IE, NBD1000101IE;
2) Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters dated July 29, 2010.
Manufacturer: Integra LifeSciences (Ireland) Limited, Sragh, Tullamore, Co, Ireland. Firm initiated recall is complete.
REASON
A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide, Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland
_____________________________________
PRODUCT
PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip. Recall # Z-2641-2010
CODE
Lot number: 1904
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN, by letter on July 2, 2010. Firm initiated recall is ongoing.
REASON
The test strips appear to under-recover Cholesterol, HDL and glucose.
VOLUME OF PRODUCT IN COMMERCE
5,805 vials (15 test strips per vial)
DISTRIBUTION
CA, MA, FL, NY, KY, VA, UT, MN, OH, MD, Belgium, England, Sweden, and Italy
___________________________________
PRODUCT
Gyrus Acmi, dissector PlasmaKnife”, REF 7035-3005, Rx only, Sterile R, CE 0344, 161416-CA. Recall # Z-2651-2010
CODE
All lots manufactured from June 1, 2007 through June 7, 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus Acmi, Inc., Southborough, MA, by letter on August 6, 2010.
Manufacturer: Gyrus Medical, Cardiff, UK. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance due to compromised package seals.
VOLUME OF PRODUCT IN COMMERCE
4,244 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Endo Ocular Directional Laser Probe, Sterile EO. Model numbers: GA-0040061; GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066. Recall # Z-2652-2010
CODE
Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumenis, Inc., Salt Lake City, UT, by letters on July 27, 2010.
Manufacturer: Peregrine Surgical, LTD, New Britain, PA. Firm initiated recall is ongoing.
REASON
Firm did not have proper 510(K) clearance.
VOLUME OF PRODUCT IN COMMERCE
250 probes
DISTRIBUTION
FL, IL, MD, CO, TX
___________________________________
PRODUCT
Synchron System(s) Immunoglobulin A (lg-A) Reagent, Part number: 467920. Recall # Z-2653-2010
CODE
Lot numbers: M812164, M902345
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter the week of June 28, 2010.
Manufacturer: Beckman Coulter, Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON
The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M902345. Using these reagent lots, some samples deficient in IgA have yielded results in the normal range. Other samples with normal levels of IgA have yielded falsely high results.
VOLUME OF PRODUCT IN COMMERCE
852 units
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Integrated Data Management System - Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010
CODE
Version numbers: 7.1.0, 7.2.0, and 7.3.0
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter dated March 10, 2010. Firm initiated recall is ongoing.
REASON
A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients.
VOLUME OF PRODUCT IN COMMERCE
84 idms software systems
DISTRIBUTION
Nationwide, Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zeland
___________________________________
PRODUCT
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems. List number: 06F23-57/514005, part number 016060-01. Recall # Z-2462-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Inc., Princeton, NJ, by letter dated August 20, 2010. Firm initiated recall is ongoing.
REASON
Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
VOLUME OF PRODUCT IN COMMERCE
277 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer foil pouch tertiary carton. LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use. Recall # Z-2623-2010
CODE
Lot number: S 10624, Exp. 2011-04
RECALLING FIRM/MANUFACTURER
LifeCell Corp., Somerville, NJ, by letters dated July 12, 2010, Firm initiated recall is complete.
REASON
Mislabeled – One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400. Recall # Z-2634-2010
CODE
Units: 03269A, 06089A, 10079A and 11099A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arkray USA Inc., Minneapolis, MN, by telephone and letter dated March 24, 2010.
Manufacturer: Hypoguard USA, Inc., Minneapolis, MN. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling is correct and properly align with 4pH part number D11400 listed on the product.
VOLUME OF PRODUCT IN COMMERCE
5,504 units
DISTRIBUTION
FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL, Israel
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
1) PRO-PET Adult Daily Vitamin Supplement. 100 count white, plastic bottle with a light blue label, and UPC code 26851-01800. Recall # V-002-2011;
2) Doctors Foster and Smith Brewers Yeast Mega-Tabs with Garlic and Essential Fatty Acids. 180 count. Dark blue label. UPC code 825141273447. Label Item #353. Recall # V-003-2011;
3) Nature's Miracle Pet Mess Easy Clean-Up. Net Wt. 12 oz. (340g), White, Red, and Black label. UPC code 018065056191. Label Item #5619. Recall # V-004-2011;
4) PetCo Breath Tabs Liver Flavor. 50 Tablets, White, Red, Blue, Brown, and Black label. UPC code 800443076576. SKU #1152092 / 16-9924. Recall # V-005-2011;
5) Doctors Foster and Smith Dis-Taste Small Dog Tablets. 250 Tablets. White, Orange, Yellow, and Black label. UPC code 825141059485. Item #33805. Recall # V-006-2011;
6) Doctors Foster and Smith Extra Strength Dis-Taste Tablets. 180 Tablets. White, Red, Yellow, and Black label. UPC code 825141008629. Item #33806. Recall # V-007-2012;
7) Doctors Foster and Smith Extra Strength Dis-Taste Tablets. 500 Tablets. White, Red, Yellow, and Black label. UPC code 825141063680. Item #33807. Recall # V-008-2011;
8) Doctors Foster and Smith Fresh Breath Tablets for Dogs. 100 Tablets. Green Brown and Black label. UPC code 825141095629. Item #35908. Recall # V-009-2011;
9) Doctors Foster and Smith Cran Health Supports Normal Urinary Tract Health. 60 Poultry-Flavored Tablets. UPC code 825141291250. Item #36763. Recall # V-010-2011;
10) PetCo Ear Powder for Dogs. 1 oz (28g). Blue, Red, White, Brown, and Black Label. UPC code 800443037652. SKU #673110 (Bottle) and SKU #1094181 (Box). Recall # V-011-2011;
11) Doctors Foster and Smith Brewers Yeast Tablets for Dogs & Cats. 750 Tablets. Green, White, Yellow, Brown, and Black Label. UPC code 825141055043, Item #72157. Recall # V-012-2011;
12) Doctors Foster and Smith Ear Powder. Net Wt. 1oz. (28g). White, Blue, Brown, Yellow, and Black Label. UPC code 825141003921. Item #9305. Recall # V-013-2011;
13) Doctors Foster and Smith Ear Powder. Net Wt. 4oz. (113g). White, Blue, Brown, Yellow, and Black Label. UPC code 825141005154. Item #9306. Recall # V-014-2011;
14) Excel 3 in 1 Ear Powder. Net Wt. 1oz. (28g). White, Blue, Brown, Yellow, Red, Purple, and Black Label. UPC code 026851007074. Item #J707. Recall # V-015-2011;
15) Excel Glucosamine Joint Care 120 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, and Black Label. UPC code 026851071105. Item #J7110. Recall # V-016-2011;
16) Excel Glucosamine Joint Care with MSM. 120 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, and Black Label. UPC code 026851071136. Item #J7113. Recall # V-017-2011;
17) Excel Deter Coprophagia Treatment Behavioral Aid. 60 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, and Black Label. UPC code 026851007203. Item #J720. Recall # V-018-2011;
18) Excel Deter Coprophagia Treatment Behavioral Aid. 500 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, and Black Label. UPC code 026851007241. Item #J724. Recall # V-019-2011;
19) Excel Gas Preventative Digestive Aid Digestive Care. 60 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, and Black Label. UPC code 026851073116. Item #J7311. Recall # V-020-2011;
20) Excel Calm-Quil Calming Tabs Behavioral Aid. 60 Tasty Chew Tabs. White, Blue, Brown, Yellow, Red, Purple, Pink, and Black Label. UPC code 026851073154. Item #J7315. Recall # V-021-2011;
21) DDS Dental Breath Mints Breath Control. 40 Tablets. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851074014. Item #J7401. Recall # V-022-2011;
22) DDS Dental Breath Mints Breath Control. 200 Tablets. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851017233. Item #K1723. Recall # V-023-2011;
23) Pro-Pet Brewer's Yeast Daily Supplement. 250 Chew Tablets. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851017752. Item #K1775. Recall # V-024-2011;
24) Excel Calcium Daily Supplement. 125 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007012. Item #K701. Recall # V-025-2011;
25) Excel Calcium Daily Supplement. 500 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007463. Item #K746. Recall # V-026-2011;
26) Excel Brewers Yeast with Garlic Skin & Coat Care. 150 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007760. Item #K776/PR. Recall # V-027-2011;
27) Excel Brewers Yeast with Garlic Skin & Coat Care. 600 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007777, Item #K777/1. Recall # V-028-2011;
28) Excel Brewers Yeast with Garlic Skin & Coat Care. 1000 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007784, Item #K778. Recall # V-029-2011;
29) Excel Brewers Yeast with Garlic Skin & Coat Care Large Breed Mega Tab. 216 Tasty Chew Tabs. White, Blue, Yellow, Red, Brown, and Black Label. UPC code 026851007852, Item #K785. Recall # V-030-2011;
30) Pro-Pet Senior Daily Vitamin Supplement. 100 Tasty Tablets. White, Blue, Red, Brown, Purple, and Black Label. UPC code 026851017011, Item #N1701. Recall # V-031-2011;
31) Excel Puppy Multi Vitamin Daily Supplement Time Release Formula. 100 Tasty Chew Tabs. White, Blue, Red, Brown, Pink, and Black Label. UPC code 026851007005, Item #N700TR. Recall # V-032-2011;
32) Excel Small Breed Multi Vitamin Daily Supplement Time Release Formula. 45 Tasty Chew Tabs. White, Blue, Red, Brown, Pink, and Black Label. UPC code 026851073017, Item #N7301. Recall # V-033-2011;
33) Excel Lutein Vision Maintenance Eye Care. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Orange, and Black Label. UPC code 026851073093, Item #N7309. Recall # V-034-2011;
34) Excel Adult Multi Vitamin Daily Supplement Time Release Formula. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Pink, and Black Label. UPC code 026851008453, Item #N845TR. Recall # V-035-2011;
35) Excel Advantage Adult Multi Vitamin Daily Supplement. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851780304, Item #P-78030. Recall # V-036-2011;
36) Excel Advantage Puppy Multi Vitamin Daily Supplement. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851780311, Item #P-78031. Recall # V-037-2011;
37) Excel Advantage Senior Multi Vitamin Daily Supplement. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851780328, Item #P-78032. Recall # V-038-2011;
38) Excel Advantage Skin & Coat Essentials Skin & Coat Care. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, Pink, and Black Label. UPC code 026851780335, Item #P-78033. Recall # V-039-2011;
39) Excel Advantage Glucosamine Plus Joint Care. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, Pink, Purple, and Black Label. UPC code 026851780342, Item #P-78034. Recall # V-040-2011;
40) Excel Advantage Glucosamine Advanced Strength Joint Care. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, Pink, Purple, and Black Label. UPC code 026851780359, Item #P-78035. Recall # V-041-2011;
41) Excel Adult Multi Vitamin Daily Supplement. 120 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851780656, Item #P-78065. Recall # V-042-2011;
42) Excel Senior Multi Vitamin Daily Supplement. 120 Tasty Chew Tabs. White, Blue, Red, Brown, Yellow, Green, and Black Label. UPC code 026851780663, Item #P-78066. Recall # V-043-2011;
43) Pro-Pet Glucosamine Joint Care. 60 Chew Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851825302, Item #P-82530. Recall # V-044-2011;
44) Pro-Pet Stool-Eating Preventative (Corprophagia Treatment). 60 Tasty Chew Tabs. White, Blue, Red, Brown, and Black Label. UPC code 026851825319, Item #P-82531. Recall # V-045-2011;
45) Pro-Pet Anti-Stress Calming Tabs. 60 Chew Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851825340, Item #P-82534. Recall # V-046-2011;
46) Pro-Pet Glucosamine Plus Joint Care. 100 Chew Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851825623, Item #P-82562. Recall # V-047-2011;
47) Pro-Pet Breath Tabs. 40 Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851826187, Item #P-82618. Recall # V-048-2011;
48) Pro-Pet Breath Mints. 200 Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851826194, Item #P-82619. Recall # V-049-2011;
49) Pro-Pet Gas Relief Digestive Aid. 40 Chew Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851826545, Item #P-82654. Recall # V-050-2011;
50) Pro-Pet Glucosamine Advanced Joint Powder. Net Wt. 10oz (283g). White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851826569, Item #P-82656. Recall # V-051-2011;
51) Pro-Pet Daily Vitamin Supplement Powder. Net Wt. 10oz (283g). White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851826583, Item #P-82658. Recall # V-052-2011;
52) Pro-Pet Puppy & Small Breed Daily Vitamin Supplement. 100 Chew Tablets. White, Blue, Red, Brown, Yellow, Pink, and Black Label. UPC code 026851830627, Item #P-83062. Recall # V-053-2011;
53) Pro-Pet Glucosamine Advanced Joint Care. 60 Chew Tablets. White, Blue, Red, Brown, Yellow, and Black Label. UPC code 026851830658, Item #P-83065. Recall # V-054-2011;
54) Excel Joint Ensure Moderate Care Joint Care. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Green, and Black Label. UPC code 026851780120, Item #P-N78012. Recall # V-055-2011
55) Excel Flare-Away Joint Tabs Pain Relief. 60 Tasty Chew Tabs. White, Blue, Red, Brown, Green, and Black Label. UPC code 026851780144, Item #P-N78014. Recall # V-056-2011;
56) Excel Joint Ensure Advanced Care. 60 Tasty Chew Tabs. UPC code 026851780137, Item #P-N78013. Recall # V-057-2011
CODE
1) Expiration date on or before 06/13;
2), thru 56) Expiration date 01/13 thru 06/13
RECALLING FIRM/MANUFACTURER
Spectrum Jungle Labs Corp., Cibolo, TX, by press release on June 22, 2010, by e-mail on June 23, 2010 and by press release and letter on July 2, 2010. Firm initiated recall is ongoing.
REASON
Product may contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,494,404 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
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PRODUCT
1) Bulk ADM Alliance Nutrition Rough-N-Ready 14 50321BHB Medicated, containing 60 gms/ton lasalocid. Recall # V-061-2011;
2) Bulk ADM Alliance Nutrition Rough-N-Ready 50321AAA. Recall # V-062-2011;
3) Bulk ADM Alliance Nutrition Rough-N-Ready 14 With Amino Gain 50634AAA. Recall # V-063-2011;
4) Bulk ADM Alliance Nutrition M&D Feenstra FDLT Balancer E3952AAA. Recall # V-064-2011;
5) Bulk - ADM Alliance Nutrition AminoGain CO-Product Grower RU 53497CCP Medicated containing 400 gm/ton Monensin. Recall # V-065-2011;
6) Bulk ADM Alliance Nutrition Custom Tjeerdsma 490 RU/MGA D6361NET Medicated containing 533.4 gm/ton Monensin and 0.000117% Melengestrol Acetate. Recall # V-066-2011;
7) Bulk ADM Alliance Nutrition Special Mix No. 490 RU/MGA 490AB Medicated containing 533.4 gm/ton Monensin and 0.000117% Melengestrol Acetate. Recall # V-067-2011
8) Bulk MoorMan's IA/MN Starter Pellet 1 CTC/DEN 12136AYW Medicated feed containing 400 gm/ton Chlortetracycline and 35 gm/ton Tiamulin. Recall # V-068-2011;
9) Bulk ADM Alliance Nutrition Feedlot Supplement 65/39 53135NED Medicated containing 333.3 gm/ton Monensin and 0.000073% Melengestrol Acetate. Recall # V-069-2011
CODE
1) Lot # LM24510;
2) Lot # LM24610;
3) Lot # LM24510;
4) Lot # LM24510;
5) Lot # LM24510;
6) Lot # LM24510;
7) Lot # LM24510;
8) Lot # LM24610;
9) Lot # LM24610
FIRM/MANUFACTURER
ADM Alliance Nutrition, Inc., Le Mars, IA, by telephone on September 5-7, 2010 and a follow-up letter on September 12, 2010. Firm initiated recall is complete.
REASON
Product could contain broken glass from a broken light bulb globe.
VOLUME OF PRODUCT IN COMMERCE
48 tons (all bulk) cattle and swine feed
DISTRIBUTION
SD, IA, MN
END OF ENFORCEMENT REPORT FOR NOVEMBER 10, 2010
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