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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 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
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
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