Z-1318-2023 Class II Ongoing
FDA device recall Z-1318-2023 was initiated by Covidien on February 10, 2023 and is designated Class II. Reason for recall: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. The recall status is ongoing. Affected quantity: 12,310 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,310 devices
Product Description
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.
Reason for Recall
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
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
Code Information
Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX