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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 62378
Product Type Biologics
Status Terminated
Recalling Firm United States Blood Bank, Inc.
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-03
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W223212445216 Class II Blood product, labeled as leukoreduced but failed to meet QC levels for White Blood Cell counts, was distributed. 1 unit B-1168-13
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