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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis)
Recall Number B-0437-13
Classification Class II
Code Info 4045540
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 44134
Product Type Biologics
Status Terminated
Recalling Firm University of Texas Medical Branch at Galveston (The)
City Galveston
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-12-20
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern TX