Device 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.
Z-1318-2023
Product summary
- Firm
- Covidien
- Event
- Event 91841
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,310 devices
- Official record key
device-enforcement:Z-1318-2023
Official wording
Reason: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Code information: Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX
Distribution pattern: 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
Derived failure modes
-
Unknown
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.