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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-0397-13
Classification Class II
Code Info 22FL28725PART1; 22FL28725PART2; 22FL28699PART1; 22FL28679PART1;
Product Distributed Qty 4 units
Reason For Recall Blood products, collected using equipment that had not been validated, were distributed.

Event Detail

Event Id 63569
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross, Penn-Jersey Region
City Philadelphia
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-07
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Pennsylvania; New Jersey