Class 2 Device Recall Shiley" LoPro Oral/Nasal Tracheal Tube Cuffed

• Date Initiated by Firm: February 10, 2023
• Date Posted: April 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1318-2023
• Recall Event ID: 91841
• 510(K)Number: K871204
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D.; ; The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for; airway management by oral/nasal intubation of the trachea for anesthesia; or other short-term procedures.
• Code Information: Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX
• Recalling Firm/ Manufacturer: Covidien; 6135 Gunbarrel Ave; Boulder CO 80301-3214
• For Additional Information Contact: Technical Support; 800-255-6774 Ext. 4
• Manufacturer Reason for Recall: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
• FDA Determined Cause: Process control
• Action: On 02/10/2023, Medtronic issued an "Urgent Medical Device Recall" letter via UPS 2 day delivery to customers informing them of potential cuff leaks from the device inflation system in Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed. Customer are instructed to: 1. Quarantine all unused product from the affected lots of Shiley" Lo-Pro Oral/Nasal Tracheal Tube Cuffed. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in their inventory to Medtronic as described on the Customer Confirmation Form. 3. Complete the enclosed Customer Acknowledgment Form even if they do not have unused inventory. 4. Pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. Additional Information for Patient Management: As stated in the Instructions for Use that accompanies each device, each tube s cuff should be tested by inflation prior to use. Use of a device with this potential manufacturing assembly error may result in a delay to treatment while an alternate device is obtained. There are no additional patient management recommendations that should be employed for patients where potentially affected devices are currently in use or were used. These patients should be monitored in accordance with your medical facility s critical care protocols. Clinical staff should appropriately assess and manage patients for any adverse clinical outcomes. For questions or further assistance, contact a Medtronic Representative or Customer Service at 800-962-9888.
• Quantity in Commerce: 12,310 devices
• Distribution: U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BTR and Original Applicant = MALLINCKRODT CRITICAL CARE