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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 Platelets Pheresis Leukocytes Reduced
Recall Number B-0337-13
Classification Class III
Code Info 004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2)
Product Distributed Qty 24 units
Reason For Recall Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.

Event Detail

Event Id 51265
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Dedham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-11-01
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern MA, ME, NH, NY, PA
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