BEUDAMED
    FDA Enforcement Class II Completed

    Enteral Infusion Pump

    Recall: Z-1347-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1347-2021
    Event ID
    87281
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    January 19, 2021
    Classification Date
    April 2, 2021
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Enteral Infusion Pump

    Reason

    The potential for air appearing in the enteral feed pumping set tubing during set-up.

    Code Info

    Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150

    Distribution

    Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey

    Quantity

    146,944,334 units