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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012
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Event Detail

Event ID 62300
Product Type Biologics
Status Terminated
Recalling Firm Blood Systems, Inc
City Billings
State MT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-23
Initial Firm Notification of
Consignee or Public		 E-Mail
Distribution Pattern Products were distributed to four domestic consignees including blood bank and health care facilities, located in Montana State. One of the four consignees responded that the unit was transfused.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Irradiated W0423110455999 Class II Blood products, collected from a donor with a history of malaria, were distributed. 1 unit B-2357-12
Red Blood Cells Leukocytes Reduced W042311056937V; W0423110503973; W042311040445E Class II Blood products, collected from a donor with a history of malaria, were distributed. 3 units B-2358-12
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