Class 2 Device Recall Portex/Sims Portex

• Date Initiated by Firm: May 19, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1016-04
• Recall Event ID: 29136
• 510(K)Number: K902180
• Product Classification: Tube Tracheostomy And Tube Cuff - Product Code JOH
• Product: Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070
• Code Information: All Lot Numbers
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc; Anesthesia and Safety Devices Division; 10 Bowman Drive; Keene NH 03431-0724
• For Additional Information Contact: Timothy J. Talcott; 609-352-3812 Ext. 2457
• Manufacturer Reason for Recall: Incompatible products may cause potential trachea trauma
• FDA Determined Cause: Other
• Action: Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.
• Quantity in Commerce: 25,400
• 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