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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63036
Product Type Biologics
Status Terminated
Recalling Firm The American National Red Cross - Southern Region
City Douglasville
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-13
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Georgia

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 003FC73672; 003FC73672(2); 003FC73672(3); Class III Blood products, which were exposed to unacceptable temperature during storage, were distributed. 3 units B-0082-13
Platelets Pheresis Leukocytes Reduced 003FC73673; 003FC73673(2); 003FC73691; 003FC73691(2); 003FC73692; 003FC73692(2); 003FC73692(3); 003FC73693; 003FC73693(2); 003FC73693(3); Class III Blood products, which were exposed to unacceptable temperature during storage, were distributed. 10 units B-0083-13
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