Class 2 Device Recall

• Date Initiated by Firm: January 22, 2003
• Date Posted: February 13, 2003
• Recall Status: Terminated on March 26, 2003
• Recall Number: Z-0555-03
• Recall Event ID: 25427
• 510(K)Number: K990072
• Product Classification: Dilator, Catheter, Ureteral - Product Code EZN
• Product: Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0
• Code Information: Lot 1050160
• FEI Number: 1825146
• Recalling Firm/ Manufacturer: Cook Urological, Inc.; 1100 West Morgan; Spencer IN 47460
• For Additional Information Contact: 812-829-4891
• Manufacturer Reason for Recall: Product is labeled sterile, but was not sterilized.
• FDA Determined Cause: Other
• Action: Customers were notified by phone call and recall letter beginning on 1/22/03.
• Quantity in Commerce: 9
• Distribution: Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
• 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.

• 510(K) Database: 510(K)s with Product Code = EZN