BEUDAMED
    FDA Enforcement Class II Terminated

    KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    Recall: Z-2492-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2492-2015
    Event ID
    71966
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 29, 2015
    Classification Date
    August 31, 2015
    Termination Date
    January 12, 2016
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    Reason

    The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

    Code Info

    Product Code 2155 - M5166T402, M5166T622, M5166T631; Product Code 2205 - M5079T606, M5086T603, M5089T612, M5089T632, M5110T611, M5110T626, M5166T642; Product Code 8169 - M5103T608; Product Code 8248 - M5082T632; Product Code 22015 - M5082T603, M5089T609, M5096T607; Product Code 22025 - M5082T627, M5096T603; Product Code 220125 M5082T617, M5096T608; Product Code 220135 - M5054T619, M5079T604, M5082T620, M5089T614, M5096T622

    Distribution

    Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

    Quantity

    19,250 cases