BEUDAMED
    FDA Enforcement Class II Terminated

    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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-0002-2014 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-0002-2014
    Event ID
    66189
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 9, 2013
    Initiation Date
    December 12, 2013
    Classification Date
    October 1, 2013
    Termination Date
    November 8, 2013
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253, United States

    Description

    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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

    On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

    Code Info

    Part Number(s): KLTSD415 Lot Number(s): IV1V3

    Distribution

    USA Nationwide Distribution in the state of NY

    Quantity

    1 case; 5 units