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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced Irradiated
Recall Number B-0191-13
Classification Class III
Code Info 004GJ51699; 004GJ51699; 004GJ51699; 004GJ51700; 004GJ51700;
Product Distributed Qty 5 units
Reason For Recall Blood products, with incorrectly transcribed platelet counts, were distributed.

Event Detail

Event Id 63330
Product Type Biologics
Status Terminated
Recalling Firm Arc Blood Services, New England Region
City Dedham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-06
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Massachusetts; New York