Class 2 Device Recall Smiths Portex

• Date Initiated by Firm: September 18, 2007
• Date Posted: November 07, 2007
• Recall Status: Terminated on May 08, 2012
• Recall Number: Z-0100-2008
• Recall Event ID: 44792
• 510(K)Number: K031057
• Product Classification: Tracheostomy Tube - Product Code JOH
• Product: Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
• Code Information: Lot Number: 1155185
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 10 Bowman Dr; Keene NH 03431-5043
• For Additional Information Contact: SAME; 603-352-3812
• Manufacturer Reason for Recall: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
• FDA Determined Cause: Process control
• Action: Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
• Quantity in Commerce: 40 units
• Distribution: Nationwide.
• 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 = JOH