FDA recall Z-1318-2023

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.

Reason for recall

Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

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

Key facts

Status

Ongoing

Initiation date

2023-02-10

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2023