Class 2 Device Recall CryoValve Pulmonary Valve & Conduct

• Date Initiated by Firm: November 04, 2003
• Date Posted: November 27, 2003
• Recall Status: Terminated 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: 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.