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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Cornea
Recall Number B-2041-13
Classification Class III
Code Info 20130190L1; 20130190R1
Product Distributed Qty 2 corneas
Reason For Recall 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.

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