BEUDAMED
    FDA Enforcement Class II Terminated

    King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.

    Recall: Z-0709-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0709-2014
    Event ID
    66869
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2014
    Initiation Date
    December 13, 2013
    Classification Date
    January 10, 2014
    Termination Date
    May 15, 2014
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253, United States

    Description

    King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.

    Reason

    KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube.

    Code Info

    Lot Number(s): I15LB

    Distribution

    Distributed in the states of CA, NY

    Quantity

    108 cases( 540 products)