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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 64979
Product Type Biologics
Status Completed
Recalling Firm Community Blood Centers of South Florida, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-29
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Michigan, Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma W036811053144 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. 1 unit B-1864-13
Red Blood Cells Leukocytes Reduced W036811053144 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. 1 unit B-1863-13
Platelets Pooled Leukocytes Reduced W036810828093 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. 1 unit B-1862-13
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