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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 48388
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Pomona
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-04-02
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern California, Arizona, Washington DC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma 06KG50494, 06KR54131, 06KR54178,06KR54290, 06GS22086, 06LQ83398,084T48723, 084T49156, 07GT00491,07GJ28906, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 10 units B-2074-13
Plasma Frozen within 24 hours 06LK96510, 06LE43292, 06GV57858, 06GF50169, 06FE13059, 084FT13509, 07FY72624, 06LQ82947,06FM42146,06GE22291, 084J 21960, 084KM77737, 084K00268, 07FC33546,07FJ97037, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 15 B-2073-13
Plasma Cryoprecipitate Poor Reduced 06GW37271,06GS23145, 084K00351, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 3 units B-2072-13
Platelets Pheresis Leukocytes Reduced Irradiated 06KR54131, 06KR54178, 06KR54290,06KG50494, 06KR54131, 06KR54178, 06KR54290, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 7 units B-2071-13
Cryoprecipitated AHF 06FS23078, 06FP66382, 06GW37271, 06GS23145, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 4 units B-2070-13
Red Blood Cells Leukocytes Reduced 06LC12397, 06LK96510, 06LQ82947, 06FP66382, 06GS22086, 06GV57858, 06LQ83398, 06GW37271, 06GF50169, 06GE22291, 06GS23145, 06LF92077, 06GF51447, 084FT13509, 084J 21960, 084KM77737, 084T48723, 084T49156, 07FC33547, 07GT00491, 07GJ28906, 07FJ97037, 07FY72624,06FT00807, 06LE43292, 06FT01385, 06FE13059, 06FM42146, 084K00268, 07FC33546 Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.. 30 B-2069-13
Red Blood Cells Leukocytes Reduced Irradiated 06FM42146, 06FM42698, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 2 units B-2068-13
Red Blood Cells (Apheresis) 06FS23078 , 06LF90461, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 2 units B-2067-13
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