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U.S. Department of Health and Human Services

Class 2 Device Recall CryValve Allograft

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 Class 2 Device Recall CryValve Allograftsee related information
Date Initiated by FirmMay 23, 2003
Date PostedJune 17, 2003
Recall Status1 Terminated 3 on December 10, 2003
Recall NumberZ-0939-03
Recall Event ID 26422
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve Pulmonary Valve & Conduit.
Code Information Donor #64108, Serial #7984345, Model #PV00 and Donor #55416, Serial #7253418, Model #PV00.
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information ContactShari L. Allen
770-419-3355
Manufacturer Reason
for Recall		Microorganisms detected in associated allografts.
FDA Determined
Cause 2		Other
ActionThe medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.
Quantity in Commerce2 individual heart valve allografts.
DistributionThe tissues were distributed to one medical facility in CT and to one physician in MT.
Total Product Life CycleTPLC 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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