Class 2 Device Recall SIMS Portex

• Date Initiated by Firm: December 12, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-0569-04
• Recall Event ID: 27986
• 510(K)Number: K980466
• Product Classification: Tube Tracheostomy And Tube Cuff - Product Code JOH
• Product: PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
• Code Information: Lot Number: K223373
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 10 Bowman Dr; Keene NH 03431-5043
• For Additional Information Contact: Timothy J. Talcott; 800-258-5361
• Manufacturer Reason for Recall: Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
• FDA Determined Cause: Other
• Action: Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
• Quantity in Commerce: 30 CASES (2/CASE)
• Distribution: AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
• 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