Class 2 Device Recall CryoValve

• Date Initiated by Firm: April 01, 2003
• Date Posted: August 29, 2003
• Recall Status: Terminated on October 21, 2004
• Recall Number: Z-1188-03
• Recall Event ID: 26985
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve Heart Valve
• Code Information: Donors processed prior to 1/26/1998
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144
• For Additional Information Contact: Sylvie L. Verdon; 770-419-3355
• Manufacturer Reason for Recall: CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.
• Quantity in Commerce: 325 units
• Distribution: Tissues were distributed to hospitals and physicians located nationwide and worldwide.
• 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.