Class 2 Device Recall CryoValve Allograft heart valve

• Date Initiated by Firm: January 23, 2003
• Date Posted: March 21, 2003
• Recall Status: Terminated on March 22, 2004
• Recall Number: Z-0675-03
• Recall Event ID: 25593
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve Allograft heart valve
• Code Information: Model number SGPV00, Serial Number: 7291867, Donor #55899
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144
• For Additional Information Contact: Sheri Allen; 678-290-4313
• Manufacturer Reason for Recall: An allograft associated with this donor has been linked to an alleged infection.
• FDA Determined Cause: Other
• Action: A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction
• Quantity in Commerce: 1 unit
• Distribution: The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
• 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.