Class 2 Device Recall Cook Antimicrobial Catheter

• Date Initiated by Firm: January 02, 2007
• Date Posted: March 16, 2007
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0637-2007
• Recall Event ID: 37102
• 510(K)Number: K950118
• Product Classification: Catheter - Product Code FOZ
• Product: COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
• Code Information: Lots 1794998 and 1793611.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 800-346-2626
• Manufacturer Reason for Recall: These catheters do not include the proximal sidehole as required by the specification.
• FDA Determined Cause: Other
• Action: Consignees were notified by phone on 1/2/07 and instructed to return the product.
• Quantity in Commerce: 100
• Distribution: Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
• 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 = FOZ