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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelet Pheresis Leukocytes Reduced Irradiated, Part 1 of 2 and 2 of 2 8653461 part 1 of 2; 8653461 part 2 of 2 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. 2 units B-1135-12
Platelet Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3 9767339 (part 1 of 3, part 2 of 3 and part 3 of 3); 8699301 (part 1 of 3, part 2 of 3 and part 3 of 3) Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, were distributed. 6 units B-1134-12
Red Blood Cells Leukocytes Reduced 8889461 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. 1 unit B-1133-12
Fresh Frozen Plasma Apheresis 9684518 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. 1 unit B-1132-12
Platelet Pheresis Leukocytes Reduced 9684754; 9684518; 9752702; 8698337, 8702797 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. 5 units B-1131-12
Platelet Pheresis Leukocytes Reduced Part 1 of 2 and 2 of 2 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) Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, was distributed. 36 units B-1130-12
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