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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January 26, 2005
05-04

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
a) Red Blood Cells. Recall # B-0342-5;
b) Platelets. Recall # B-0343-5;
c) Recovered Plasma. Recall # B-0344-5.
CODE
a), b) and c) Unit E48273.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter and facsimile dated February 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

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PRODUCT
Human Corneal Tissue. Recall # B-0361-5.
CODE
Tissues 04-0521 and 04-0522.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX, by telephone on August 25, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeated reactive for the Hepatitis B Surface Antigen (HBsAg) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
TX.

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PRODUCT
a) Red Blood Cells Units. Recall # B-0369-5;
b) Platelets. Recall # B-0370-5;
c) Fresh Frozen Plasma. Recall # B-0371-5;
d) Cryoprecipitated AHF. Recall # B-0372-5.
CODE
a) Units KH49666, KH49661, KL14039, GG84742,
GV59857, KE66453, KE65414, KE67758;
b) Units FW25597, KL14039, KE65414;
c) Units KH49666, KH49661, KL14039, KE 66453,
KE65414, KE67758;
d) Unit KH49666.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile transmissions dated March 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
PA, and RI.

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PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0488-5.
CODE
Unit number 0939929.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone on April 21, 2003, and by letter on May 5, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0489-5.
CODE
Unit numbers 26120-3991-01 and 26120-3991-02.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on February 9, 2004, and by letter on February 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0490-5.
CODE
Unit number 26169-6284.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on July 15, 2003. 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
AR.

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PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0491-5.
CODE
Unit numbers 26120-1591-1 and 26120-1591-2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR, by telephone on January 28, 2004.
Manufacturer: Blood Systems, Inc., Texarkana, TX. Firm initiated recall is complete.
REASON
Blood products, collected by a method that may have compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0492-5.
CODE
Unit number 21LC04195.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on October 31, 2003, and by letter on November 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected by a method that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

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PRODUCT
a) Red Blood Cells. Recall # B-0518-5;
b) Cryoprecipitated AHF. Recall # B-0519-5.
CODE
a) and b) Unit 0861307.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letters dated May 22, 2003 and May 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Recovered Plasma. Recall # B-0485-5.
CODE
Unit number 1631777.
RECALLING FIRM/MANUFACTURER
Department of the Army, Armed Services Blood Bank Center, Tacoma, WA, by letter on July 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

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PRODUCT
a) Platelets. Recall # B-0493-5;
b) Cryoprecipitated AHF. Recall # B-0494-5;
c) Cryoprecipitated AHF, Pooled. Recall # B-0495-5;
d) Fresh Frozen Plasma. Recall # B-0496-5;
e) Plasma, Cryoprecipitate Reduced. Recall # B-0497-5.
CODE
a) Unit numbers 21GW16029, 21GC55138, 21GE02911, and
21GE06052;
b) Unit numbers 21GY43371, 21GY42594, 21GY42420,
21GY41233, 21GH99072, 21GH98213, 21GH98026,
21GH98366, 21GW14867, 21GZ02249, 21GZ01772,
21KK17288, 21KJ25341, 21KG24250, 21KE06739,
21GJ99214, 21GE05646, 21GE04814, 21GE03990,
21GE03313, and 21GE03200;
c) Pool number 551 (contained recalled unit 21GE05377);
d) Unit numbers 21GM91206, 21GM85335, 21GM85122,
21GN02077, 21GV04998, 21GL33091, 21GL33060,
21GL32972, 21Q87857, 21Q87773, 21Q86904,
21Q89751, 21Q83364, 21Q83360, and 21GE06052;
e) Unit numbers 21GY43371, 21GY42594, 21GH98366,
21GJ99214, 21GE04814, 21GE03990, 21GE03313, and
21KE06739.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region,
Portland, OR, by telephone and letter on April 11, 2003, and by letter on May 21, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were designated as traumatic collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units, 1 pool.
DISTRIBUTION
Nationwide and PR.

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PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
Recall # B-0498-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0499-5.
CODE
a) Unit numbers 26120-0509-1, 26120-0509-2,
26120-0516-1, 26120-0516-2, 26120-0525-1,
26120-0525-2, 26120-0532-1, 26120-0532-2,
26120-0536-1, 26120-0536-2, 26120-0551-1,
26120-0551-2, 26120-0568-1, 26120-0568-2,
26120-0569-1, 26120-0569-2, 26120-0570-1,
26120-0588-1, 26120-0588-2, 26120-0596-1,
26120-0596-2, 26120-0600-1, 26120-0600-2,
26120-0612-1, 26120-0612-2, 26120-0619-1,
26120-0619-2, 26120-0623-1, 26120-0623-2,
26120-0630-1, 26120-0630-2, 26120-0636-1,
26120-0636-2, 26120-0644-1, 26120-0644-2,
26120-0648-1, 26120-0648-2, 26120-0658-1,
26120-0658-2, 26120-0659-1, 26120-0659-2,
26120-0663-1, 26120-0663-2, 26120-0666-1,
26120-0666-2, 26120-0676-1, 26120-0676-2,
26120-0681-1, 26120-0681-2, 26120-0691-1,
26120-0691-2, 26120-0695-1, 26120-0695-2,
26120-0699-1, 26120-0699-2, 26120-0709-1,
26120-0709-2, 26120-0712-1, 26120-0712-2,
26120-0715-1, 26120-0715-2, 26120-0718-1,
26120-0718-2, 26120-0720-1, 26120-0720-2,
26120-0725-1, 26120-0725-2, 26120-0730-1,
26120-0730-2, 26120-0738-1, 26120-0738-2,
26120-0739-1, 26120-0739-2, 26120-0751-1,
26120-0751-2, 26120-0754-1, 26120-0754-2,
26120-0763-1, 26120-0763-2, 26120-0768-1,
26120-0768-2, 26120-0789-1, 26120-0789-2,
26120-0796-1, 26120-0796-2, 26120-0799-1,
26120-0799-2, 26120-8805-1, 26120-8805-2,
26120-8824-1, 26120-8824-2, 26120-8888-1,
26120-8888-2, 26120-8889, 26120-8892-1,
26120-8892-2, 26120-8898-1, 26120-8898-2,
26120-8900-1, 26120-8900-2, 26120-8908-1,
26120-8908-2, 26120-8912-1, 26120-8912-2,
26120-8920-1, 26120-8920-2, 26120-8927-1,
26120-8927-2, 26120-8929-1, 26120-8929-2,
26120-8936-1, 26120-8936-2, 26120-8937-1,
26120-8937-2, 26120-8955-1, 26120-8955-2,
26120-8961-1, 26120-8982-1, 26120-8982-2,
26120-8986-1, 26120-8986-2, 26120-8993-1,
26120-8993-2, 26120-8994-1, 26120-8994-2,
26120-8995-1, 26120-8995-2, 26120-8997-1,
26120-8997-2, 26120-8998-1, 26120-8998-2,
26120-9003-1, 26120-9003-2, 26120-9005-1,
and 26120-9038-1;
b) Unit numbers 26120-0511, 26120-0524, 26120-0528,
26120-0530, 26120-0543, 26120-0548, 26120-0550,
26120-0565, 26120-0567, 26120-0582, 26120-0583,
26120-0585, 26120-0604, 26120-0616, 26120-0629,
26120-0634, 26120-0635, 26120-0637, 26120-0664,
26120-0674, 26120-0675, 26120-0687, 26120-0693,
26120-0694, 26120-0696, 26120-0707, 26120-0710,
26120-0711, 26120-0714, 26120-0717, 26120-0721,
26120-0724, 26120-0726, 26120-0727, 26120-0743,
26120-0748, 26120-0761, 26120-0776, 26120-0779,
26120-0783, 26120-0793, 26120-8812, 26120-8828,
26120-8830, 26120-8890, 26120-8909, 26120-8914,
26120-8916, 26120-8917, 26120-8924, 26120-8931,
26120-8935, 26120-8941, 26120-8944, 26120-8948,
26120-8950, 26120-8956, 26120-8960, 26120-8962,
26120-8971, 26120-8976, 26120-8979, 26120-8991,
26120-9020, 26120-9023, 26120-9042, 26120-9053,
26120-9063, 26120-9072, 26120-9090, 26120-9092,
26120-9103, 26120-9108, 26120-9113, and 26120-9129.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR, by telephone on March 10 and 11, 2004.
Manufacturer: Blood Systems, Inc., Hot Springs, AR. Firm initiated recall is complete.
REASON
Blood products, collected from donors that were incorrectly tested for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
210 units.
DISTRIBUTION
AR, OK, MS, TX, NV, and FL.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0520-5.
CODE
Units 0872738, 0876546.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated December 18, 2002. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as being negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

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PRODUCT
Capture Solid Phase Test Systems - Capture-R Ready-Screen Test Wells. Recall # B-0527-5.
CODE
Lot G113 - 350 units.
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter or fax dated November 11, 2004. Firm initiated recall is complete.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot.350 units.
DISTRIBUTION
Nationwide and Canada.

END OF ENFORCEMENT REPORT FOR January 26, 2005

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