Recall Z-0273-2025— King Systems Corp. dba Ambu, Inc.

Name: FDA recall Z-0273-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-26

Class II · Ongoing

Class II FDA medical device recall by King Systems Corp. dba Ambu, Inc., initiated 2024-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430. Reason: 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..

Recalling firm: King Systems Corp. dba Ambu, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-26
Firm location: Noblesville, IN, United States

Product description

KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430

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.

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