Class 2 Device Recall Hudson RCI Tracheal Tubes

• Date Initiated by Firm: January 09, 2015
• Date Posted: February 10, 2015
• Recall Status: Terminated on September 27, 2016
• Recall Number: Z-1078-2015
• Recall Event ID: 70248
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
• Code Information: Catalog no. 5-22110, Lot no. 01M1300076.
• Recalling Firm/ Manufacturer: Teleflex Medical; 2917 Weck Dr; Research Triangle Park NC 27709-0186
• For Additional Information Contact: Tara Torres; 610-378-0131
• Manufacturer Reason for Recall: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
• FDA Determined Cause: Labeling mix-ups
• Action: Teleflex Medical sent an " Urgent Medical Device Recall Notification" dated January 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to immediately discontinue use and quarantine any of the affected products, return the product and to complete the enclosed Recall Acknowledgement Form even if they do not have the affected product in stock. Distributors were instructed to communicate the recall to any of their customers who may have received product included within the scope of the recall. Have the customers return any affected product to them, together with a completed Recall Acknowledgement Form. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
• Quantity in Commerce: 300 units
• Distribution: Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
• 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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.