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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 50330
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Farmington
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-09-18
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern NE

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596; 033GM59812 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 6 units B-0548-13
Platelets Pooled Leukocytes Reduced 033GM57596;033GM55654 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-0549-13
Fresh Frozen Plasma 033GM57596;033GW54331;033GM55654 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 3 units B-0550-13
Platelets Leukocytes Reduced 033GM35609 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0551-13
Blood and Blood Products for Reprocessing 033GM37984 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0552-13
Platelets Pheresis Leukocytes Reduced 033FP63417P1;033FP63417P2 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-0553-13
Red Blood Cells (Apheresis) Leukocytes Reduced 033FE00104B2;033FE00104B1 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-0554-13
Red Blood Cells Leukocytes Reduced Irradiated 033GM35609 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0555-13
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