BEUDAMED
    FDA Enforcement Class II Terminated

    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿ King LTS-D" Supraglottic Airway.

    Recall: Z-2532-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2532-2020
    Event ID
    85832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bound Tree Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    May 14, 2020
    Classification Date
    July 7, 2020
    Termination Date
    December 7, 2023
    Address
    5000 Tuttle Crossing Blvd, Dublin, OH, 43016-1534, United States

    Description

    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿ King LTS-D" Supraglottic Airway.

    Reason

    Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s airway as intended by the kit

    Code Info

    Lot Number: ASM0025699

    Distribution

    Nationwide Distribution

    Quantity

    167 kits