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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Corneas
Recall Number B-2312-12
Classification Class II
Code Info AAG744ODCN; AAG744OSCN
Product Distributed Qty 2 corneas, (1 right, 1 left)
Reason For Recall Human Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed.

Event Detail

Event Id 62305
Product Type Biologics
Status Terminated
Recalling Firm SightLife
City Seattle
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern One cornea was shipped to each of 2 physicians in Japan.
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