King Systems Corp. dba Ambu, Inc. recalls AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pate

Recalled November 6, 2024 · FDA recall Z-0269-2025 · King Systems Corp.

Hazard

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. · FDA Class II

Units

N/A

Sold at

Nationwide

Description

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Product

AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

Manufacturer(s)

King Systems Corp. dba Ambu, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →