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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced Irradiated
Recall Number B-0443-13
Classification Class II
Code Info W115112332625J;
Product Distributed Qty 1 unit
Reason For Recall Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.

Event Detail

Event Id 63668
Product Type Biologics
Status Terminated
Recalling Firm LifeSouth Community Blood Centers, Inc.
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-19
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Alabama