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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 65594
Product Type Biologics
Status Terminated
Recalling Firm Wellmont Health System Dba Marsh Regional Blood Center
City Kingsport
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-03
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Tennessee; Virginia; Maryland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma W241213500713; W241212200249; Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed 2 B-2303-13
Red Blood Cells Leukocytes Reduced W241212200429; ; Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed 1 B-2304-13
Blood and Blood Products for Reprocessing W241211501914; W241212200429; W241212200760; W241212200943; Class III Blood products, collected from a donor who reported testing positive for hepatitis, were distributed 4 B-2305-13
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