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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis) Leukocytes Reduced
Recall Number B-2125-13
Classification Class II
Code Info W115113088151B; W115113088151B;
Product Distributed Qty 2
Reason For Recall Blood products, collected without the performance of a WBC count during instrument re-validation, were distributed.

Event Detail

Event Id 65388
Product Type Biologics
Status Terminated
Recalling Firm Lifesouth Community Blood Centers, Inc. - Mobile Region
City Mobile
State AL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Alabama