Class 2 Device Recall Cook PTFE Wire Guide

• Date Initiated by Firm: June 12, 2007
• Date Posted: August 09, 2007
• Recall Status: Terminated on November 25, 2009
• Recall Number: Z-1162-2007
• Recall Event ID: 38283
• Product Classification: ureteral/renal access guidewire - Product Code EZB
• Product: Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
• Code Information: Lot U1621121
• Recalling Firm/ Manufacturer: Cook Urological, Inc.; 1100 W Morgan St; Spencer IN 47460-9426
• For Additional Information Contact: 812-829-4891
• Manufacturer Reason for Recall: Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
• FDA Determined Cause: Process control
• Action: Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.
• Quantity in Commerce: 100
• Distribution: Nationwide and Canada.
• 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.