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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 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
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 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
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 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
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
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