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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/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Shari L. Allen
770-419-3355
Manufacturer Reason
for Recall		 Microorganisms were detected in associated allografts after initial release of donor.
FDA Determined
Cause 2		 Other
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.
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