Enforcement Report

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

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May 17, 2006
06-20

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
Ashman's Ackees in Brine 19 oz cans -- product of Jamaica, Recall # F-162-6
CODE
A7ACK2475, A7ACK2505, A7ACK2565, A7ACK2655, A7ACK2665, A7ACK2645, A7ACK2685, and A7ACK2705
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harvest Foods, Hartford, CT, by visit and press release on December 23, 2005.
Manufacturer: Ashman Food Products, Ltd., St. Catherine, Jamaica. Firm initiated recall is complete.
REASON
The product contains unacceptable levels (above 100 ppm) of hypoglycin.
VOLUME OF PRODUCT IN COMMERCE
400 cases
DISTRIBUTION
NY, MA, and CT

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PRODUCT
Catfish, Aqua Star brand. 12 oz. retail packs made up of random weight individually quick frozen fillet portions primarily vacuum packed and secondarily packed in pre-printed, plastic retail bags. Bag labeling states AquaStar CATFISH FIllets NET WT 12 oz. Nutrition Facts Total Carbohydrate 35g FARM RAISED, Recall # F-163-6
CODE
All products with codes beginning with SOS04 and SOS05. 05 indicates product packed in 2005, 04 indicates product packed in 2004
RECALLING FIRM/MANUFACTURER
Universal Tea Company, Inc, Tigard, OR, by fax on April 10, 2006 and April 17, 2006. Firm initiated recall is complete.
REASON
Misbranded -- product label states product contains 35g of carbohydrates per serving, however, product contains 0g of carbohydrates per serving.
VOLUME OF PRODUCT IN COMMERCE
5,358 cases
DISTRIBUTION
Nationwide

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PRODUCT
a) Pharmagenx brand Ventilean dietary supplement sold as a liquid in 4 ounce (120 ml)
and 8 ounce (240 ml) plastic bottles. The liquid product was also distributed in plastic
ampoules labeled 'VENTILEAN 10 ml (2Srv.)' The ampoules were given away at trade
shows, by retail stores or in small amounts to individual consumers, Recall # F-166-6;
b) Pharmagenx brand Ventilean LipoGels (soft gelatin capsules). The gelatin capsules
are sold in 48 count and 96 count plastic bottles, Recall # F-167-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Pharmagenx AKA Vita Shots, San Marcos, CA, by letters on April 1, 2005. Firm initiated recall is ongoing.
REASON
Some lots of the product were found to contain Clenbuterol a drug not approved for human use in the United States.
VOLUME OF PRODUCT IN COMMERCE
2,400 bottles and 100 cases of ampoules
DISTRIBUTION
Nationwide, Canada, Mexico, Ecuador, Nigeria and Japan

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

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PRODUCT
NOW Kidvits, Animal-Shaped Chewables, A Dietary Supplement; packaged in 50 Lozenges and 100 Lozenges bottles/12 bottles per case; UPC 33739-03870 and 33739-03872, Recall # F-168-6
CODE
All lots of Kid Vits product numbers 3870 (50 lozenge bottles) and 3872 (100 lozenge bottles)
RECALLING FIRM/MANUFACTURER
Recalling Firm: NOW Foods, Bloomingdale, IL, by letter dated October 3, 2005.
Manufacturer: Kabco, Inc, Amityville, NY. Firm initiated recall is complete.
REASON
The product contains Aspartame but does not list Aspartame as an ingredient on the label and does not bear the phenylalanine.
VOLUME OF PRODUCT IN COMMERCE
12,362 bottles
DISTRIBUTION
NC, CA, PR, and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Amoclan (Amoxicillin and Clavulanate Potassium Powder for Oral Suspension USP), 200mg/28.5mg per 5mL), supplied in 50mL (NDC 0143-9981-50) , 75mL (0143-9981-75), and 100mL (0143-9981-01 ) bottles, Rx only, Recall # D-237-6
CODE
Lot - Exp. Date: AG007A, 03/2007; AG010A, 06/2007; AG011A, 06/2007; AG006B, 03/2007; AG008B, 03/2007; AG009B, 06/2007; AG011B, 06/2007; AG007C, 03/2007; AG008C, 03/2007; AG009C, 06/2007; AG010C, 06/2007; AG011C, 06/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceuticals Corp., Eatontown, NJ, by letter on March 23, 2006.
Manufacturer: Hikma Pharmaceuticals, Amman, Jordan. Firm initiated recall is ongoing.
REASON
Discoloration (clavulanic acid -- 9 month stability)
VOLUME OF PRODUCT IN COMMERCE
16,518 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Carticel (Autologous Cultured Chondrocytes), Recall # B-0981-6
CODE
Lot # CC17694-21 Expiration: December 22, 2005
RECALLING FIRM/MANUFACTURER
Genzyme Biosurgery, Cambridge, MA, by letter dated December 21, 2005, firm initiated recall is complete.
REASON
Carticel, possibly contaminated with Novosphingobium capsulatum, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot
DISTRIBUTION
MA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0985-6
b) Recovered Plasma, Recall # B-0986-6
CODE
a) and b) 06GV75980 and 06GP03112
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on July 24, 2003 and by letter on July 30, 2003, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0995-6
CODE
36KH13005
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbia, SC, by telephone on January 14, 2004 and by letter on March 18, 2004, 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
SC

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PRODUCT
a) Red Blood Cells, Recall # B-1030-6
b) Fresh Frozen Plasma, Recall # B-1031-6
CODE
a) and b) Unit: 17KY79877
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by fax, telephone and letter on October 15, 2003, firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening regarding high risk behavior was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN

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PRODUCT
Platelets, Recall # B-1038-6
CODE
Unit: M82162
RECALLING FIRM/MANUFACTURER
Anderson Area Medical Center Blood Bank, Anderson, SC, by letter dated November 24, 1999, firm initiated recall is complete.
REASON
Blood product, possibly contaminated with Serratia liquifasciens, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
Fresh Frozen Plasma, Recall # B-1039-6
CODE
Unit: 71M763674
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center, Dunwoody, GA, by telephone on October 15, 2004, firm initiated recall is complete.
REASON
Blood product, associated with a red blood cell product that failed filtration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1040-6.
CODE
Unit: GW00365
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 13, 2004, firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

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PRODUCT
Source Plasma, Recall # B-1042-6
CODE
Unit: NG0025921
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX, by telephone and facsimile on October 28, 2002, firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1044-6
CODE
Unit 3104412
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc. Indianapolis, IN, by telephone on February 24, 2006 and by letter dated March 21, 2006, 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
IN

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1046-6
CODE
Unit 4137632
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on March 1, 2006 and by letter dated March 21, 2006, firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1047-6
CODE
Units 4507155 (3 parts)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 4, 2003, firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL

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PRODUCT
Platelets, Recall # B-1048-6
CODE
Unit 1142882
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Southern Florida, Lauderhill, FL, by telephone on April 14, 2003, firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
a) Red Blood Cells, Recall # B-1049-6
b) Recovered Plasma, Recall # B-1050-6
CODE
a) and b) Unit 06GN26595
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letter dated June 11, 2004 and by e-mail on June 3, 2004, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1051-6
CODE
Unit 10753-7939
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on May 30, 2004, firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1053-6;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1054-6;
c) Cryoprecipitated AHF, Recall # B-1055-6
CODE
a) Units 10043-7797, 10044-2615, 10044-2616, 10044-2627, 10044-2632, 10044-2637;
b) Unit 10044-2646;
c) Unit 10043-7797
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 5, 2004, firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were designated as low volume collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AZ

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PRODUCT
Misys Laboratory Blood Bank Module, Version 6.1, Recall # B-1065-6
CODE
Version 6.1
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by telephone and electronic mail dated March 15, 2006, firm initiated recall is ongoing.
REASON
Defects in the design of software could result in data being out of sync with the accession number, patient and/or units displayed on the screen.
VOLUME OF PRODUCT IN COMMERCE
1unit
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1066-6
CODE
Units: 17FG11722, 17FG13237, 17FG13962, 17FG14327, 17FG18723, 17FG18728, 17FJ22726, 17FK07075, 17FK10876, 17FK11670, 17FL10491, 17FL10718, 17FL11228, 17FR04993, 17FR05124, 17FR05125, 17FR05242, 17FV10102, 17GN02982, 17GR14887, 17GR14972, 17GR15931, 17GR15933, 17GR15934, 17GR15935, 17GR16211, 17GR20949, 17GR20950, 17GR20951, 17GR20952, 17GR20953, 17GR20955, 17GR20956, 17GR20957, 17GR20958, 17GR20959, 17GR20960, 17KC43585, 17KC44987, 17KC44989, 17KC44992, 17KC44993, 17KC44999, 17KC45012, 17KM38835, 17KM38836, 17KM38961, 17KM41245, 17KN92516, 17KN94366, 17KQ53046, 17KQ53143, 17KQ53675, 17KQ55718, 17KT59699, 17KT59921, 17KT66694, 17KT68358, 17KX79345, 17KX82534, 17KY53862, 17KY54243, 17KY55175, 17KY57992, 17KY60202, 17KZ28210, 17FM05253, 17FN02088, 17FN02129
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter dated April 11, 2003, firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
MN, WI, SD, OH, MA and CA

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PRODUCT
Source Plasma, Recall # B-1068-6
CODE
Units: MI123310, MI123735, MI124615, MI126403, MI127241, MI127712, MI128090, MI128781, MI129341, MI129911, MI131673, MI132308, MI143473, MI145702, MI148780, MI149574, MI150032, MI150471, MI150759, MI151225, MI151526, MI151953, MI152246, MI152634, MI152930, MI159318, MI159858, MI165302, MI164961, MI164538, MI164136, MI163764, MI163252, MI162998, MI162512, MI161632, MI160897, MI160352, MI165660, MI165807, MI166161, MI166599, MI166994, MI167447, MI167772, MI168203, MI168640, MI169321, MI169824, MI170652, MI170938, MI191572, MI194369, MI194565, 04MINA0463, 04MINA3770, 04MINA4707, 04MINA9008, 04MINA9771, 04MINB1084, 04MINE1079, 04MINE2113, 05MINA0853, 05MINA4459, 05MINA7842, 05MINA8428, 05MINA9255, 05MINA9680, 05MINB0991, 05MIMB1425, 05MINB1996, 05MINB5616, 05MINB8427, 05MINB9091, 05MINB9933, 05MINC0941, 05MINC1751, 05MINC2299 05MINC3646
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by fax on October 5, 2005, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a dura mater graft during brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
79 units.
DISTRIBUTION
CA, NC and France

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1069-6
b) Cryoprecipitated AHF), Recall # B-1070-6
c) Recovered Plasma, Recall # B-1071-6
CODE
a), b) and c) Unit: 3770059
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by e-mail and letter dated December 15, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA, NJ and Switzerland

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1072-6
b) Platelets, Recall # B-1073-6
c) Recovered Plasma, Recall # B-1074-6
CODE
a), b) and c) Unit: 3770030
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by e-mail on December 15, 2004, 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
3 units.
DISTRIBUTION
LA, MI and Switzerland

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PRODUCT
Source Plasma, Recall # B-1076-6
CODE
Units: 7030197795, 7030197430, 7030196563, 7030196468, 7030195157, 7030194673, 7030194066, 7030192019, 7030191696, 7030190289, 7030189884, 7030189156, 7030188798, 7030188123, 7030187336, 7030186983, 7030185913, 7030185584, 7030184003, 7030183509, 7030183025, 7030182181, 7030181566, 7030180976, 7030180665, 7030179937, 7030179704
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., San Antonio, TX, by fax on February 26, 2002 and March 1, 2002, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
UK

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PRODUCT
Platelets Pheresis Leucocytes Reduced Irradiated, Recall # B-1085-6
CODE
Unit: 06KS43607
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by telephone on April 14, 2005 and by letter dated April 26, 2005, 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
CA

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1086-6
CODE
Units 1158791 -- split unit
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letters dated August 8 and 9, 2005, firm initiated recall is complete.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
Red Blood Cells, Recall # B-1087-6
CODE
Units: 1001033, 1002474
RECALLING FIRM/MANUFACTURER
Aultman Health Foundation, Canton, OH, by facsimile dated September 26, 2005, firm initiated recall is complete.
REASON
Red Cells, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
Source Plasma, Recall # B-1088-6
CODE
Units: G-30722-083, G-31091-083, G-36159-083, G-36786-083, G-37663-083, G-42749-083, G-42962-083, G-48822-083, and G-49248-083.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Calexico, CA, by facsimile dated September 20, 2002, firm initiated recall is complete
REASON
Blood products which were collected from a donor who was previously deferred for testing reactive for antibodies to the human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Spain

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1089-6;
b) Fresh Frozen Plasma, Recall # B-1090-6
CODE
a) and b) Unit number 12FG14467
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on August 4, 2005 and by letter dated August 8, 2005, firm initiated recall is complete
REASON
Blood Products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0945-6
CODE
Unit numbers: 71X03946 (parts 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Dunwoody, GA, by letter dated May 13, 2004, firm initiated recall is complete.
REASON
Platelets, which were not manufactured within the acceptable time frame from collection, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and AL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0966-6
CODE
Unit number: 36FV07138
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on September 9, 2005 firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SC

______________________________
PRODUCT
Source Plasma. Recall # B-0982-6
CODE
Unit numbers OJ211110, OJ237133, OJ236651, OJ236376, OJ235857, OJ235405, OJ233962, OJ233614, OJ233096, OJ231967, OJ231775, OJ230903, OJ230522, OJ230174, OJ229840, OJ229465, OJ229082, OJ228745, OJ227747, OJ227474, OJ226669, OJ226380, OJ225870, OJ225602, OJ225203, OJ224578, OJ224075, OJ223801, OJ223133, OJ222575, and OJ222303.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Jacksonville, FL, by facsimile dated May 15, 2003, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was previously deferred for testing reactive for (HBsAg) hepatitis B surface antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units.
DISTRIBUTION
NY and NC

______________________________
PRODUCT
Recovered Plasma, Recall # B-0983-6
CODE
Unit numbers 004KL84455 and 004LQ24122.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by computer program logic on January 17, 2006 and January 19, 2006, firm initiated recall is complete.
REASON
Blood products, which tested negative for viral makers, but was collected from a donor who was subsequently determined to have previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1041-6
CODE
Unit 9403690
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on March 28, 2002, firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Source Plasma, Recall # B-1043-6
CODE
Unit 0350017877
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., McAllen, TX, by facsimile on August 11, 2004, 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
Spain

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1045-6
CODE
Unit 4728182
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on January 17, 2006, firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Recovered Plasma, Recall # B-1052-6
CODE
Unit 10753-7939
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by facsimile on June 11, 2003, firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1062-6
CODE
Unit 12KQ35317
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on January 13, 2003, firm initiated recall is complete.
REASON
Red Blood Cells, missing antibody identification information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1067-6
CODE
Units: 17FK11480, 17FK11482,17FK11483, 17FK11484, 17FK11486, 17FK11488, 17FK11490, 17FK11491, 17FK11492, 17FK11493, 17FK11494, 17FK11495, 17FK11496, 17FK11498, 17FK11499, 17FK11501, 17FK11502, 17FL10429, 17FL10434, 17FL10436, 17FL13246, 17FL13247, 17FL13248, 17FL13257, 17FR03049,17FV07035, 17GR14887, 17GR14964, 17GR14966, 17GR14972, 17KC43588, 17KE06815, 17KN92504, 17KN92505, 17KN92510, 17KN92516, 17KN92724, 17KT66694, 17KX81337, 17KX83844, 17KX83845 17KY53835, 17KY54243, 17KY57026, 17KY57038, 17KY57043, 17KY57049, 17KY57055
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter dated April 11, 2003, firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
MN, WI, SD, OH, MA and CA

______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1075-6
CODE
Unit: 8308895 (Part C of split product)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by telephone on January 9, 2002, firm initiated recall is complete.
REASON
Blood product, collected in an expired bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Krupin Eye Valve, P/N 6003, Recall # Z-0844-06;
b) Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V, Recall # Z-0845-06;
c) Glaucoma Aqueous Shunt, 365 mm, valved, P/N EG365V, Recall # Z-0846-06;
d) Valve-EV Glaucoma Ultra-Smooth, P/N 6006, Recall # Z-0847-06
CODE
a) Serial numbers: 10671A through 10714A; 10807A through 10813A;
108866A through 10905A;
b) Serial numbers: 10727A, 10733A, 10734A, 10735A, 10736A, 10737A, 10744A,
10745A, 10746A, 10747A, 10748A, 10749A, 10750A, 10751A, 10794A, 107795A,
10796A, 10797A, 10798A, 10799A, 10806A, 11056A through 11101A, and 11443A
through 11456A;
c) Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A,
11518A, 11550A, 11551A, 11554A, 11556A, and 11559A;
d) Serial numbers: 11102A through 11107A
RECALLING FIRM/MANUFACTURER
Eagle Vision, Inc., Memphis, TN, by letters beginning on April 12, 2006 and a second notice dated April 19, 2006. Firm initiated recall is ongoing.
REASON
Products may have deformed valves which would cause the valve not to close within the specified pressure tolerances.
VOLUME OF PRODUCT IN COMMERCE
192 units
DISTRIBUTION
Nationwide, Canada, Columbia, Turkey, and The Netherlands

______________________________
PRODUCT
Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215, The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm's TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable. Recall # Z-0849-06
CODE
TV 59965, TV 59967
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurosurgery, Goleta, CA, by letter and fax on March 8, 2006.
Manufacturer: Antrin Enterprises, Inc, Ojai, CA. Firm initiated recall is ongoing.
REASON
Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhibit burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
FL, IL, NY, PA, and TN

______________________________
PRODUCT
a) MD3 X-ray system, Recall # Z-0851-06;
b) MD4 X-ray system, Recall # Z-0852-06
CODE
a) Site numbers 59515, 62374, 13546, 47128, 76329, 83654, 82673, 35471, 59524,
37977, 74051, 6648, X0344, 38442, 41032, 74007, 46926, 86146, 25949, 26086,
47033, 38922, 62458, 76085, 38714, 38716, X0972, 44865, 67609, 6847, 44814,
86568, 35445, 62392, 73923, 26071, 74032, 40941, 83047, 74026, 62444, 38422,
25923, 25945, X1198, 6546, 50317, 38289, 17669, 6536, 6931, X0917, 35403,
X0345, 38409, 6498, X0663, X1677, 44772, 49593, 73976, 46637, X0911, 26019,
26020, 26021, 13661, 38418, 6937, 74015, X0470, 50026, 37932, 37878, 73860,
X0791, 59571, 44760, 41462, 82721, 17467, 37907, 47045, X0660, 38266, X0855,
76213, 101151, 62502, 76388, 37935, X0056, X0346;
b) Site numbers 52459, 38929, 41378, 20279385, 38783, 20279430, 83957, 82628,
83038, 13721, 85034, 80306, 38993, 84930, X1321, X1077, 44812, 100014, 50328,
17656, 83367, 38586, 76834, 87176, 41426, 82800, 10388, 41111, 17622, 13918,
84854, 102034, 38202, 52471, 76804, 50251, 44898, 13258, 86545, 38587,
20283876, 82688, 38635, 47160, 45042, 38917, 20278521, 86328, 13879, 41069,
76975, X1277, X1078, 76951, 84463, 76877, 13172, 38944, 41143, 85694, 87140,
59546, 13704, 45039, 20280426, 76869, 52455, 84892, 41271, 87302, 6842, 41031,
6825, X0662, 87030, 76808, 6838, 86218, 85491, 50340, 82687, 38912, 41287,
41000, 100700, 41439, 41156, 10458, 35484, 103056, X0934, 38501, 14099, 62938
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 6, 2006.
Manufacturer: Philips Medical Systems, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for unexpected table movement
VOLUME OF PRODUCT IN COMMERCE
MD3- 93 units; MD4 -- 94 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software (Version 4.0, 4.1, or 4.2), Recall # Z-0854-06
CODE
100943VP0, 67392II1, 36521VE3, 70827VE1, 419453BU6436332BU1, 70800VE8, 44586VE6, 341GE8, 97197VP8, 99813VP8, 97983VP1, 70820VE6, 58626VE3, 70795VE0, FRB3510J25, 58630VE5, 58624VE8, 58589VE3, 7823VE0, 44579VE1, 44597VE3, 44585VE8, 25125VE6, 425022BU1, 70796VE8, 93086VE7, 37621BU4, 76906VE7, 76899VE4, 70798VE4, 65504VE3, 65603VE3, 36543VE7, 58628VE9, 70811VE5, 44584VE1, 44581VE7, FRB3430VBM, 44589VE0, 44598VE1, 44582VE5, 44594VE0, 72740VE4, 1189GE0, 2030GE5, 2085GE0, 2025GE5, 72477II3, 72480II7, 343GE4, 97203VP4, 98272VP8, 423277BU3, 349GE1, 425018BU9, FRB3300M6G, 99699VP1, 98371VP8, 101216VP0, 425015BU5, 237GE8, 364GE0, 339GE2, 101196VP4, 419382BU7, 419383BU5, 366GE5, 367GE3, 357GE4, 2085GE9, 419457BU7, 25128VE0, 98436VP9, 99981VP3, 36513VE0, 98623UP2, 101000VP8, 2028GE9, 2799GE5, 1089GE2, 419450BU2, 101280VP6, 67269VE1, 100855VP6, 66250II2, 346GE7, 363GE2, 345GE9, 1073VP5, 101170VP9, 98516VP8, 2802GE7, 419356BU1, 66244II5, 1487GE8, 67389II7, 365GE7, 425021BU3, 383GE0, 25132VE2, 101334VP1, 95972VP6, 419449BU4, 2031GE3, 2800GE1, 36517VE1, FRB33605L9, 1024GE9, 95307VP5, 102235VP9, 102232VP6, 425204BU5, 1124GE7, 1122GE1, 419455BU1, 419456BU9, 102220VP1, 102555VP0, 97622VP5, 72249II6, 67210VE5, FRB33605KX, 419257BU1, 95268VP9, 338GE4, 101404VP2, 2090GE9, 2087GE5, 101308VP5, 101251VP7, 421989BU5, 342GE6, 99627VP2, 97933VP6, 98653VP9, 66249II4, 72479II9, 25126VE4, 356GE6, 25130VE6, 65450VE9, DE31500056, 347GE5, 421367BU4, 100912VP5, 25123VE1, 25124VE9, 99867VP4, DE24600031, 99910VP2, 101246VP7, 419357BU9, 101171VP7, 102825VP7, 100664VP2, 102856VP2, 424101BU4, 425020BU5, 354GE1, 36518VE9, 100885VP3, 2801GE9, USV41104ST, 2091GE7, USV41103MJ, 99994VP6, 102133VP6, 419549BU1, 25137VE1, 102078VP3, 425351BU4, 1066GE0, 98816VP2, 97591VP2, 99631VP4, 423318BU5, 2086GE7, 97905VP4, 100690VP7, 350GE9, 25139VE7, 1120GE5, 100001VP7, 2084GE2, 391228BU4, 101190VP7, 99909VP4, 1123GE9, 2803GE5, 98474VP0, 25127VE2, 67384II8, 98815VP4, 101288VP9, 101287VP1, 66241II1, 25134VE8
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by letter dated October 8, 2004.
Manufacturer: General Electric Medical Systems, SCS, Bue Cedex, France. Firm initiated recall is complete.
REASON
Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with this version of software may introduce a shift of up to 1.5 PET Voxels, which can be as much as 8 mm with certain zoom factors.
VOLUME OF PRODUCT IN COMMERCE
199 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
CR DX-S, DX-S, Computed radiography system (Digitizer), Software versions: STR1102B and below, Recall # Z-0855-06
CODE
Serial numbers: SN10001-SN1079
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corporation, Greenville, SC, by visit at the time of upgrading on November 3, 2005, December 19, 2005 and December 28, 2005.
Manufacturer: AGFA, Mortsel, Belgium. Firm initiated recall is complete.
REASON
Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
DC, MS, OR

______________________________
PRODUCT
Convex Array Transducer used with B-K Ultrasound Scanners, Model number: 8667, Recall # Z-0856-06
CODE
Serial Numbers: 1855380, 1855547, 1855548, 1856835, 1856837, 1857171, 1857173, 1857180, 1857427, 1857435, 1857515, 1857748, 1858482, 1858841, 1859751, 1859902, 1860250, 1860262, 1860487, 1860661, 1860858, 1861488, 1861580, 1861581, 1861823, 1861849, 1863084, 1863082
RECALLING FIRM/MANUFACTURER
Recalling Firm: B K Medical Systems, Inc, Wilmington, MA, by letter on April 10, 2006.
Manufacturer: B-K Medical A/S, Herlev, Denmark. Firm initiated recall is ongoing.
REASON
Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU), Recall # Z-0857-06
CODE
6025108 thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128, 6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru 6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772 thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853 thru 6048856 and 40300736
RECALLING FIRM/MANUFACTURER
GE Healthcare, Madison, WI, by letter dated November 16, 2005. Firm initiated recall is ongoing.
REASON
Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.
VOLUME OF PRODUCT IN COMMERCE
113 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Prolieve™ Thermodilatation® Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, Recall # Z-0843-06
CODE
Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Celsion Corporation, Inc, Columbia, MD, by letters on February 17, 2006 and March 22, 2006.
Manufacturer: Accellent Juarez, Inc, Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
VOLUME OF PRODUCT IN COMMERCE
1,515 kits
DISTRIBUTION
MA, IL, NJ, FL, NY, CO, OH, and MI

______________________________
PRODUCT
Cook Esophageal Dilator Set ------- Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook® *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook® * Recall # Z-0848-06
CODE
Lot: W2110292, Correct expiration on Small OEM Label: Mar-08, Expiration date on Large Label Apr-08; W2118663, Correct exp.: Mar-08, Exp. On large label: Apr-08; W2126166, Correct exp.: Apr-08, Exp. On large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label: May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018, Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.: Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label: May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318, Correct exp.: Sep-08, Exp. On large label: Oct-08
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on/about April 21, 2006. Firm initiated recall is ongoing.
REASON
Large product label contains an incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
AL

______________________________
PRODUCT
K-ASSAY CRP (2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP (2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP (2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap. Recall # Z-0850-06
CODE
Lot Number: 666011, Exp: 07/2007
RECALLING FIRM/MANUFACTURER
Kamiya Biomedical Company, Seattle, WA, by telephone on April 11, 2006 and April 17, 2006. Firm initiated recall is complete.
REASON
Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent.
VOLUME OF PRODUCT IN COMMERCE
185 kits
DISTRIBUTION
Nationwide and Singapore

______________________________
PRODUCT
Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software, Recall # Z-0853-06
CODE
Serial Numbers: 7SLJX61 - GX280 ; 3V35V61-GX280; 6SLJX61 - GX280; 7S35V61 - GX280; FT35V61 -GX280; GS35V61 - GX280; JT35V61 -GX280; 1V35V61 - GX280; 4V35V61 -GX280; 8V35V61 - GX280; DT35V61 - GX280; BV35V61 -GX280; JV35V61 -GX280; GV35V61 - GX280; JS35V61 -GX280; BPB1761 - GX280
RECALLING FIRM/MANUFACTURER
Affymetrix, Inc, Bedford, MA, by email dated April 14, 2005 and by letter on December 28, 2005. Firm initiated recall is ongoing.
REASON
Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA, IN, The Netherlands, and Switzerland

END OF ENFORCEMENT REPORT FOR MAY 17, 2006

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