BEUDAMED
    FDA Enforcement Class II Terminated

    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.

    Recall: Z-1361-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1361-2015
    Event ID
    70610
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 8, 2015
    Initiation Date
    February 17, 2015
    Classification Date
    April 1, 2015
    Termination Date
    October 27, 2015
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060-4253, United States

    Description

    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.

    Reason

    Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.

    Code Info

    Part number 7169 Lot number 1737171

    Distribution

    US Nationwide in the states of IL, IN, KY, MI, PA, and TN

    Quantity

    900 units