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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Cornea
Recall Number B-2415-13
Classification Class II
Code Info 120442OSCN
Product Distributed Qty 1 cornea
Reason For Recall Human Cornea, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.

Event Detail

Event Id 64355
Product Type Biologics
Status Terminated
Recalling Firm Rochester Eye and Human Parts Bank, Inc.
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern New York