BEUDAMED
    FDA Enforcement Class II Terminated

    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

    Recall: Z-2781-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2781-2015
    Event ID
    71909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Salter Labs
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    August 4, 2015
    Classification Date
    September 17, 2015
    Termination Date
    May 6, 2016
    Address
    2365 Camino Vida Roble, Carlsbad, CA, 92011-1505, United States

    Description

    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

    Reason

    The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

    Code Info

    Lot Numbers 042015 through 070615A Series 8660, 8960, 8961, 8966, 8984. Nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7), Inspiratory valve cap (part number 600116).

    Distribution

    Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.

    Quantity

    8,975