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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 July 15, 2004
Date Posted October 20, 2004
Recall Status1 Terminated 3 on December 31, 2007
Recall Number Z-0026-05
Recall Event ID 30191
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Pulmonary Valve & Conduit
Code Information Donor Number: 68668, Serial Number: 8037696, Model Number: 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		 A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
FDA Determined
Cause 2		 Other
Action The physician was notified by letter on 07/15/2004.
Quantity in Commerce 1 tissue
Distribution The tissue was shipped to one physician in 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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