BEUDAMED
    FDA Recall 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 · Initiated December 10, 2012

    Recall

    Recall Number
    Z-0615-2013
    Event Number
    63857
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    FEI Number
    1419652
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    December 10, 2012
    Posted
    December 27, 2012
    Terminated
    March 30, 2018
    Address
    2349 W Lake St, Addison, IL, 60101-6183

    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.

    Action

    ArjoHuntleigh sent an Urgent Field Correction Recall letters dated December 10, 2012, to all affected customers, informing the accounts that the pumps were marketed without proper FDA approval, and that ArjoHuntleigh is removing the pumps from the market and replacing them with a suitable alternative. The accounts were requested to disseminate the information to all organizations where the devices may have been transferred, and to complete the Customer Response Form and return it to ArjoHuntleigh by mail, fax or e-mail. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

    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