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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 February 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0746-04
Recall Event ID 28558
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Aortic Valve and Conduit
Code Information Donor #68607, Serial #8044081, Model #AV00
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. P. Tyler Cochran
770-419-3355
Manufacturer Reason
for Recall		 CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.
FDA Determined
Cause 2		 Other
Action Consignees were notified by telephone on 02/18/2004.
Quantity in Commerce 1 unit
Distribution DC, TX
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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