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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Cornea
Recall Number B-0498-14
Classification Class II
Code Info 111215OD; 111215OS
Product Distributed Qty 2 corneas
Reason For Recall Human 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 67654
Product Type Biologics
Status Terminated
Recalling Firm Upstate New York Transplant Services
City Buffalo
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-11
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Argentina
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