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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Event Detail

Event ID 45160
Product Type Biologics
Status Terminated
Recalling Firm Blood Systems, Inc.
City Scottsdale
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-08-28
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern ND, CA, MS, AL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 300577900, 300577903, 300577905, 300577906, 305638450, 305638452, 305638457, 305638459, 305638460, 305638465, 305638466, 305638468, 305639302, 305639303, 305639306, 305639311, 305639313, 305639317, 305639318, 305639319 Class II Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed. 20 units B-0485-14
Red Blood Cells Apheresis Leukocytes Reduced 300577901 (2 units), 305638451 (2 units), 305638461 (2 units), 305638469 (2 units), 305638471 (2 units), 309605582 (2 units) Class II Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed. 12 units B-0484-14
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