BEUDAMED
    FDA Enforcement Class II Terminated

    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.

    Recall: Z-2107-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2107-2014
    Event ID
    68731
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    July 9, 2014
    Classification Date
    July 23, 2014
    Termination Date
    March 9, 2017
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000, United States

    Description

    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.

    Reason

    The temperature probe does not properly connect to the temperature port.

    Code Info

    Catalog Number: 780-96, Lot numbers: 02L1300073 & 02A140133.

    Distribution

    Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines

    Quantity

    11,679 units