BEUDAMED
    FDA Enforcement Class III Terminated

    King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

    Recall: Z-2255-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2255-2013
    Event ID
    66185
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 25, 2013
    Initiation Date
    September 3, 2013
    Classification Date
    September 19, 2013
    Termination Date
    April 15, 2014
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060-4253, United States

    Description

    King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

    Reason

    Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.

    Code Info

    Part Number KLTD2125 Lot Number I10RG

    Distribution

    Distributed in NY.

    Quantity

    9 cases; 45 products