BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

    Recall: Z-0577-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0577-2018
    Event ID
    79045
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 21, 2018
    Initiation Date
    July 15, 2016
    Classification Date
    February 9, 2018
    Termination Date
    April 24, 2020
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617, United States

    Description

    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

    Reason

    Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.

    Code Info

    GS025081

    Distribution

    International Distribution to:Germany

    Quantity

    1