Recall Z-1318-2023— Covidien

Name: FDA recall Z-1318-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Class II · Ongoing

Class II FDA medical device recall by Covidien, initiated 2023-02-10. It names one FDA 510(k) clearance: K871204. 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: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system..

Recalling firm: Covidien
Classification: Class II
Status: Ongoing
Initiated: 2023-02-10
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K871204 — CUFFED TRACHEAL TUBE (MULTIPLE)Mallinckrodt Critical Care·cleared 1987-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.