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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve

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  Class 2 Device Recall CryoValve see related information
Date Initiated by Firm January 26, 2004
Date Posted October 01, 2005
Recall Status1 Terminated 3 on October 06, 2005
Recall Number Z-1593-05
Recall Event ID 32905
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Pulmonary Valve and Conduit
Code Information Donor #68538, Serial #8045214, Model #PV00
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
Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
FDA Determined
Cause 2
Other
Action Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.
Quantity in Commerce 1 tissue
Distribution CA
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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