KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to pr...
FDA Recall #Z-0270-2025 — Class II — September 26, 2024
Product Description
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
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
21939 units
Distribution
Nationwide
Code Information
UDI-DI: 00612649210162 (Shipper Label); 00612649210155 (Piece Label)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated