BEUDAMED
    FDA Enforcement Class II Terminated

    Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.

    Recall: Z-0615-2013 · Reported January 2, 2013

    Enforcement

    Recall Number
    Z-0615-2013
    Event ID
    63857
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2013
    Initiation Date
    December 10, 2012
    Classification Date
    December 27, 2012
    Termination Date
    March 30, 2018
    Address
    2349 W Lake St, N/A, Addison, IL, 60101-6183, United States

    Description

    Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.

    Reason

    The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

    Code Info

    Model 512003, all serial numbers

    Distribution

    USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.

    Quantity

    2,859 unts