Class 2 Device Recall CryoValve

• Date Initiated by Firm: December 10, 2003
• Date Posted: February 25, 2004
• Recall Status: Terminated on July 23, 2004
• Recall Number: Z-0548-04
• Recall Event ID: 28345
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve Pulmonary Valve and Conduit
• Code Information: Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144-3632
• For Additional Information Contact: Mr. P. Tyler Cochran; 770-419-3355
• Manufacturer Reason for Recall: As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
• FDA Determined Cause: Other
• Action: The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.
• Quantity in Commerce: 1 unit
• Distribution: The allograft was shipped to one physician in TX.
• 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.