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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-0454-13
Classification Class II
Code Info 038GP54750; 038GP54750; 038GP54756; 038GP54756; 038GP54772; 038GP54772; 038GP54775; 038GP54775; 038GP54779; 038GP54779; 038GP54779; 038GP54824; 038GP54824; 038GP54824;
Product Distributed Qty 14 units
Reason For Recall Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed.

Event Detail

Event Id 63695
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Svs. Indiana-Ohio Region
City Fort Wayne
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Michigan; Ohio; Indiana