BEUDAMED
    FDA Enforcement Class II Ongoing

    AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

    Recall: Z-0269-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0269-2025
    Event ID
    95451
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    King Systems Corp. dba Ambu, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 6, 2024
    Initiation Date
    September 26, 2024
    Classification Date
    October 30, 2024
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060-4253, United States

    Description

    AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

    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.

    Code Info

    UDI-DI: 00612649210131 (Shipper Label); 00612649210148 (Piece Label)

    Distribution

    Nationwide

    Quantity

    N/A