Class 2 Device Recall Cook Flexor DL

• Date Initiated by Firm: January 05, 2007
• Date Posted: January 25, 2007
• Recall Status: Terminated on May 01, 2008
• Recall Number: Z-0377-2007
• Recall Event ID: 37115
• 510(K)Number: K043418
• Product Classification: endoscope - Product Code FED
• Product: Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
• Code Information: Lot U1546391.
• FEI Number: 1825146
• 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, as the packages may not have been sealed.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
• Quantity in Commerce: 4
• Distribution: Massachusetts, Maine, New Hampshire and Puerto Rico.
• 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 = FED