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U.S. Department of Health and Human Services

Class 3 Device Recall CryoValve

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  Class 3 Device Recall CryoValve see related information
Date Initiated by Firm December 17, 2004
Date Posted March 10, 2005
Recall Status1 Terminated 3 on January 27, 2006
Recall Number Z-0581-05
Recall Event ID 30803
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Aortic Valve and Conduit
Code Information Donor #62654, Serial #7816174, 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		 Records noted that the infant donor's mother had tested positive for Hepatitis B.
FDA Determined
Cause 2		 Other
Action Physicians were notified by letter on 12/17/2004.
Quantity in Commerce 1 tissue
Distribution CA, FL
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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