• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Cornea
Recall Number B-0970-13
Classification Class II
Code Info 2012010601; 2012032093; 2012042243; 2012042299; 2012053203; 2012053261; 2012064195; 2012074467; 2012074497; 2012074999; 2012085207; 2012096095; 2012106947; 2012107037; 2012107087; 2012107203; 2012107253; 2012128065; 2012128281; 2012128317; 2011127530; 2011127666; 2012010602; 2012032094; 2012042244; 2012042300; 2012053204; 2012053262; 2012064196; 2012074468; 2012074498; 2012075000; 2012085208; 2012096096; 2012106948; 2012107038; 2012107088; 2012107204; 2012107254; 2012117420; 2012128066; 2012128282; 2012031727; 2012021505; 2012021506; 2012021291; 2012021292; 2011127529; 2011127665
Product Distributed Qty 49
Reason For Recall Human Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine 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 64205
Product Type Biologics
Status Terminated
Recalling Firm Lions Eye Institute for Transplant & Research, Inc.
City Tampa
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Indonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic
-
-