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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Platelet Pheresis Leukocytes Reduced Part 1 of 2 and 2 of 2
Recall Number B-1130-12
Classification Class II
Code Info 9684969 (part 1 of 2 and part 2 of 2); 9764768 (part 1 of 2 and part 2 of 2); 9765357 (part 1 of 2 and part 2 of 2); 9771884 (part 1 of 2 and part 2 of 2); 9763523 (part 1 of 2 and part 2 of 2); 9745447 (part 1 of 2 and part 2 of 2); 9761407 (part 1 of 2 and part 2 of 2); 9755010 (part 1 of 2 and part 2 of 2); 8721317 (part 1 of 2 and part 2 of 2); 7396779 (part 1 of 2 and part 2 of 2); 7385402 (part 1 of 2 and part 2 of 2); 7392161( part 1 of 2 and part 2 of 2); 8728456 (part 1 of 2 and part 2 of 2); 8729268 (part 1 of 2 and part 2 of 2); 8723646 (part 1 of 2 and part 2 of 2); 8676244 (part 1 of 2 and part 2 of 2) ; 8714796 (part 1 of 2 and part 2 of 2) ,8636458 (part 1 of 2 and part 2 of 2)
Product Distributed Qty 36 units
Reason For Recall Blood products, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

Event Detail

Event Id 52235
Product Type Biologics
Status Terminated
Recalling Firm Florida's Blood Centers, Inc.
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-04-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern FL, CA, NY, NC, SC
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