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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

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

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