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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 46676
Product Type Biologics
Status Terminated
Recalling Firm The Blood Alliance, Inc.
City Saint Augustine
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-09-26
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 8604481; 8604477; 8604418; 1251960; 8604227; 7807516; 7807522; 8604129; 8604171; 7807314; 7806375; 7806344; 5924178; 7806218; 7806202, 7805994, 7805982, 7805959, 4805907, 8603589, 7805765, 7805758, 7805752, 4208542, 7426585, 8603492, 7805649, 7805593, 7805591, 7805542 Class III Blood products, for which there was no documentation for the time period out of controlled storage, were distributed. 30 units B-1661-13
Red Blood Cells (Apheresis) Leukocytes Reduced 4826808; 7807745; 9870298, 9868793, 1957226. Class III Blood products, for which there was no documentation for the time period out of controlled storage, were distributed. 5 units B-1660-13
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