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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm December 02, 2004
Date Posted April 06, 2005
Recall Status1 Terminated 3 on June 28, 2010
Recall Number Z-0686-05
Recall Event ID 31243
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Aortic Valve and Conduit
Code Information Donor #56844, Serial #7399626, Model #AV00
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall		 An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
FDA Determined
Cause 2		 Other
Action Consignee was notified by letter on 12/02/2004.
Quantity in Commerce 1 tissue
Distribution TN
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.
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