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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve Pulmonary Valve & Conduct

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  Class 2 Device Recall CryoValve Pulmonary Valve & Conduct see related information
Date Initiated by Firm November 04, 2003
Date Posted November 27, 2003
Recall Status1 Terminated 3 on May 06, 2004
Recall Number Z-0167-04
Recall Event ID 27664
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Pulmonary Valve & Conduct
Code Information Model Number PV00, Serial Number 8041312
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Sylvie L. Verdon
770-419-3355
Manufacturer Reason
for Recall		 CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
FDA Determined
Cause 2		 Other
Action Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.
Quantity in Commerce One unit
Distribution The tissue was shipped to one hospital in MO.
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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