BEUDAMED
    FDA Recall 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 · Initiated August 4, 2015

    Recall

    Recall Number
    Z-2781-2015
    Event Number
    71909
    Firm
    Salter Labs 2365 Camino Vida Roble
    FEI Number
    1314417
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 4, 2015
    Posted
    September 17, 2015
    Terminated
    May 6, 2016
    Address
    Carlsbad, CA, 92011-1505

    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.

    Action

    Salter Labs sent a Medical Device Recall letter dated July 24 2015. The letter identified the affected product, problem and actions to be taken. The letter states that all affected product can be returned to Salter Labs for replacement at no charge with product specifically inspected for a tighter fit on the inspiratory valve cap. Customers were instructed to complete and return the Return Response Form as soon as possible. For any questions contact Salter Labs Customer Support at 800-421-0024 or the local Salter Labs representative.

    Distribution

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

    Quantity

    8,975