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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 06, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on June 29, 2010
Recall Number Z-0173-05
Recall Event ID 30218
Product Classification Heart-Valve, Allograft - Product Code MIE
Product Alt. Aortic Valve & Conduit
Code Information Donor #34698, Serial #6356222, Model #AV05
Recalling Firm/
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. P. Tyler Cochran, CQA, CTBS
Manufacturer Reason
for Recall
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
FDA Determined
Cause 2
Action Consignees were notified by letter on/about May 6, 2004.
Quantity in Commerce 1 unit
Distribution Nationwide, Austria, Canada, Germany
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.