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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Red Blood Cells
Recall Number B-2028-12
Classification Class II
Code Info 004LE80082, 004LE80083, 004LE80084, 004LE80086, 004LE80087, 004LE80095, 004LE80097, 004LE80098, 004LE80099, 004LE80100
Product Distributed Qty 10 units
Reason For Recall Blood products, collected using equipment that was not validated, were distributed.

Event Detail

Event Id 47955
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 2008-03-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern MA, NY