Class 2 Device Recall CryoValve

• Date Initiated by Firm: January 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 15, 2004
• Recall Number: Z-0814-04
• Recall Event ID: 28764
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve, Pulmonary Valve and Conduit
• Code Information: Donor #69347, Serial #8022177, Model #PV00
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144-3632
• For Additional Information Contact: Mr. P. Tyler Cochran, CQA, CTBS; 770-419-3355
• Manufacturer Reason for Recall: CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347.
• FDA Determined Cause: Other
• Action: The consignee was contacted by telephone by the CryoLife Medical Director on 01/30/2004.
• Quantity in Commerce: 1 unit
• Distribution: The tissue was distributed to one physician in IN.
• 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.