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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Cornea
Recall Number B-1432-13
Classification Class II
Code Info 04871302
Product Distributed Qty 1 Cornea
Reason For Recall Human corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.

Event Detail

Event Id 64767
Product Type Biologics
Status Terminated
Recalling Firm North Carolina Eye Bank, Inc. (The)
City Winston Salem
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-11
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Texas