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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 47926
Product Type Biologics
Status Terminated
Recalling Firm Northwest Florida Blood Center, Inc.
City Pensacola
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-01-16
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern FL, AL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 4571232A; 4571232B; 4927022A; 4927022B; 4927021A; 4927021B. Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 6 units B-1657-13
Platelets Pheresis Leukocytes Reduced Irradiated 4668239A; 4668239B Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 2 units B-1656-13
Red Blood Cells Leukocytes Reduced 4360813; 4360796 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 2 units B-1655-13
Red Blood Cells 4668249 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 1 unit B-1654-13
Red Blood Cells Leukocytes Reduced Irradiated 5220672 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 1 unit B-1653-13
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