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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-0061-14
Classification Class III
Code Info W120613205108, W120613205160
Product Distributed Qty 2 units
Reason For Recall Blood products, collected using an automated collection device that was not validated after repairs, were distributed.

Event Detail

Event Id 66229
Product Type Biologics
Status Terminated
Recalling Firm Michigan Blood
City Saginaw
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-12
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Michigan
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