Class 2 Device Recall CryoValve

• Date Initiated by Firm: April 30, 2003
• Date Posted: May 22, 2003
• Recall Status: Terminated on April 29, 2004
• Recall Number: Z-0866-03
• Recall Event ID: 26205
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve Allograft, Heart valve
• Code Information: Donor #61838, Serial #7691913, Model #SGPV00; Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00; Donor #64779, Serial #7883080, Model #SGPV00; Donor #64779 77888910, Model #SGPV00; Donor #64779, Serial #7888909, Model #SGAV00; and Donor #63941, Serial #7894710, Model #SGPV00.
• 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.
• FDA Determined Cause: Other
• Action: Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.
• Quantity in Commerce: 8 units
• Distribution: The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.
• 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.