KING LTSD recalled over sterility concerns

Recall date

September 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0274-2025

FDA classification

Class II

Brand / firm

King Systems Corp. dba Ambu, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431