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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description Cornea
Recall Number B-0525-13
Classification Class II
Code Info 20110177; 20110178
Product Distributed Qty 2
Reason For Recall Human Corneas, recovered with a donor with risk factors for relevant communicable disease agents and diseases, were distributed.

Event Detail

Event Id 63810
Product Type Biologics
Status Terminated
Recalling Firm Banco de Ojos del Leonismo Puertorriqueno
City Rio Piedras
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Puerto Rico