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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 42331
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Louisville
State KY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-05-11
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern KY, OH, IN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 24FY08618; 24FY08617; 24FY08608; 24FY08609; 24FY08611; 24FY08612; 24FY08612; 24FY08613; 24FY08613; 24FY08614; 24FY08615; 24FY08616; 24FY08616 Class II Blood products, collected using equipment that had not been validated, were distributed. 13 units B-1753-12
Platelets Pheresis Leukocytes Reduced Irradiated 24FY08611; 24FY08614; 24FY08615 Class II Blood products, collected using equipment that had not been validated, were distributed. 3 units B-1752-12
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