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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells 004LE80082, 004LE80083, 004LE80084, 004LE80086, 004LE80087, 004LE80095, 004LE80097, 004LE80098, 004LE80099, 004LE80100 Class II Blood products, collected using equipment that was not validated, were distributed. 10 units B-2028-12
Fresh Frozen Plasma 004LE80082, 004LE80083, 004LE80087, 004LE80099 Class II Blood products, collected using equipment that was not validated, were distributed. 4 units B-2029-12
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