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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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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
Distribution Pattern TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) 4045540 Class II Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. . 1 unit B-0437-13