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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description Red Blood Cells Leukocytes Reduced Irradiated
Recall Number B-2357-12
Classification Class II
Code Info W0423110455999
Product Distributed Qty 1 unit
Reason For Recall Blood products, collected from a donor with a history of malaria, were distributed.

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.