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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-1613-12
Classification Class II
Code Info 42KW34507 Part 1 ;42KW34507 Part2 ; 42KW34507 Part 3; 42KW34509 Part 1; 42KW34509 Part2 ;42KW34509 Part 3;
Product Distributed Qty 6
Reason For Recall Blood products, which did not meet the acceptable product specifications, were distributed.

Event Detail

Event Id 38807
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Cleveland
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-05-24
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern The ARC Blood Center in Cleveland, OH distributed products to three hospitals in Ohio.
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