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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Cornea
Recall Number B-1636-12
Classification Class II
Code Info SA200801181, SA200801182
Product Distributed Qty 2
Reason For Recall Corneas, recovered from a donor who had not been properly evaluated for hemodilution, were distributed.

Event Detail

Event Id 48920
Product Type Biologics
Status Terminated
Recalling Firm San Antonio Eye Bank
City San Antonio
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-06-23
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern CA, Saudi Arabia