KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mo...
FDA Recall #Z-0274-2025 — Class II — September 26, 2024
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
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.
Recalling Firm
King Systems Corp. dba Ambu, Inc. — Noblesville, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21591 units
Distribution
Nationwide
Code Information
UD-DI: 00612649212708 (Shipper Label); 00612649212715 (Piece Label)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated