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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 May 05, 2003
Date Posted May 22, 2003
Recall Status1 Terminated 3 on July 17, 2003
Recall Number Z-0861-03
Recall Event ID 26286
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Allograft, Pulmonary Heart valve & Conduit.
Code Information Model #PV00, Serial #7916346
Recalling Firm/
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Shari L. Allen
Manufacturer Reason
for Recall
Microorganisms were detected in associated allografts after initial release of donor.
FDA Determined
Cause 2
Action The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
Quantity in Commerce 1 unit
Distribution Allograft was distributed to and implanted by one physician in California.
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.