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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64207
Product Type Biologics
Status Terminated
Recalling Firm Medic Inc
City Knoxville
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Tennessee

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced W071209008364 Part 1; W071209008364 Part 2; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 2 B-1108-13
Red Blood Cells Leukocytes Reduced W071208025659; 9312114; 9468600; 9263803; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 4 B-1109-13
Fresh Frozen Plasma 9468600; 9505841; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 2 B-1110-13
Red Blood Cells Irradiated 9440117; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 1 B-1111-13
Platelets 9440117; 9427804; 9226669; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 3 B-1112-13
Red Blood Cells 9505841; 9088034; 9427804; 9226669; 9359488; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. 5 B-1113-13
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