King Systems Corp. dba Ambu, Inc.: Device Recall

Recall #Z-0274-2025 · 09/26/2024

Class II: Risk

Recall Details

Recall Number: Z-0274-2025
Classification: Class II
Product Type: Device
Recalling Firm: King Systems Corp. dba Ambu, Inc.
Status: Ongoing
Date Initiated: 09/26/2024
Location: Noblesville, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21591 units

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.

Product Description

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

Distribution Pattern

Nationwide

Other Recalls by King Systems Corp. dba Ambu, Inc.

Class II: Risk 09/26/2024

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: Risk 09/26/2024

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: Risk 09/26/2024

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: Risk 09/26/2024

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: Risk 09/26/2024

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.

View all recalls by King Systems Corp. dba Ambu, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.