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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65453
Product Type Biologics
Status Terminated
Recalling Firm Lifepoint, Inc.
City Charleston
State SC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-12
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern South Carolina

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 20130190L1; 20130190R1 Class III Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 2 corneas B-2041-13
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