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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve Allograft

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  Class 2 Device Recall CryoValve Allograft see related information
Date Initiated by Firm February 04, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on July 16, 2003
Recall Number Z-0672-03
Recall Event ID 25675
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Allograft, Heart valve
Code Information Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
Recalling Firm/
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Shari Allen
Manufacturer Reason
for Recall
Microorganisms were detected in distributed allografts.
FDA Determined
Cause 2
Action CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department ¿ Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.
Quantity in Commerce 2 units
Distribution The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.