FDA recall Z-0276-2025

King Systems Corp. dba Ambu, Inc. · Class II · device

Product

KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325

Reason for recall

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.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-09-26
Report date: 2024-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0276-2025