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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Cornea
Recall Number B-0388-13
Classification Class III
Code Info 120349100; 120349200
Product Distributed Qty 2
Reason For Recall Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 63678
Product Type Biologics
Status Terminated
Recalling Firm East Tennessee Lions Eye Bank
City Knoxville
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Tennessee
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