Recall Z-1318-2023 ยท BTR Tube, Tracheal (W/Wo Connector)
Covidien
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.
| Date | Apr 1, 2023 (initiated Feb 10, 2023) |
| Status | Open, Classified |
| Reason | Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. |
| Root 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 C |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) Mallinckrodt Critical Care, Apr 21, 1987 |