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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64239
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 2012-12-05
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern GA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 03KE41985 Class III Blood products, stored at unacceptable storage temperatures, were distributed. 1 unit B-1234-13
Platelets Pheresis Leukocytes Reduced 003KE42042; 003KE42043; 003KE42045; 03KE41985; 03KE41986; 03KE41987; 03KE41987; 03KE42029; 03KE42030; Class III Blood products, stored at unacceptable storage temperatures, were distributed. 9 units B-1235-13
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