BEUDAMED
    FDA Enforcement Class II Terminated

    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).

    Recall: Z-1678-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1678-2015
    Event ID
    71110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 3, 2015
    Initiation Date
    April 14, 2015
    Classification Date
    May 26, 2015
    Termination Date
    July 7, 2015
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894, United States

    Description

    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).

    Reason

    The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit.

    Code Info

    M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303

    Distribution

    Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.

    Quantity

    11 cases each containing 20 individual endotracheal tubes