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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 38910
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 2007-06-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern CA, MA, ME, NH, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Plasma Frozen 04FF62346, 04FF62348, 04FF62357, 04FF62358, 04FF62362, 04FF62364, 04FF62373, 04FF62376, 04FF62386, 04FF62389, 04FF62393, 04FF62402, 04FF62403, 04FF62405, 04FF62407, 04FF62412, 04FF62419, 04FF62421, 04FF62424, 04FF62426, 04FF62525, 04FF62530, 04FJ19204, 04FJ19228, 04FJ19233, 04FJ19236, 04FJ19245, 04FJ19247, 04FJ19253, 04FJ19263, 04FJ19270, 04FJ19272, 04FJ19277, 04FJ19281, 04FJ19284, 04FJ19295, 04FJ19297, 04FJ19303, 04FJ19312, 04FJ19317, 04FJ19324, 04FJ19333, 04FJ19337, 04FJ19488, 04FJ19500, 04FJ19505, 04FJ19507, 04FJ19591, Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed 48 B-0368-13
Blood and Blood Products for Reprocessing 04FF62350, 04FF62352, 04FF62357, 04FF62358, 04FF62376, 04FF62386,04FF62396, 04FF62405, 04FF62407,04FF62421, 04FF62424, 04FJ19204, 04FJ19228, 04FJ19230, 04FJ19233, 04FJ19245, 04FJ19270, 04FJ19272,04FJ19277. 04FJ19284, 04FJ19295, 04FJ19317, 04FJ19333, 04FJ19495 04FJ19500, 04FJ19504, 04FJ19507 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed 27 B-0371-13
Plasma Frozen 04FF62362,04FF62364,04FJ19247,04FJ19324 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed 4 B-0370-13
Red Blood Cells Rejuvenated Irradiated 04FJ19207, 04FJ19217, 04FJ19220, 04FJ19224. 04FJ19230, 04FJ19476,04FJ19487, 04FJ19595, 04FJ19601 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed 9 B-0369-13
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