BEUDAMED
    FDA Recall Terminated

    Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.

    Recall: Z-2200-2008 · Initiated June 16, 2008

    Recall

    Recall Number
    Z-2200-2008
    Event Number
    48679
    Firm
    Utah Medical Products, Inc
    FEI Number
    1718873
    Product Code
    HFN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 16, 2008
    Posted
    September 11, 2008
    Terminated
    June 23, 2011
    Address
    7043 South 300, West Midvale, UT, 84047

    Description

    Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.

    Reason

    Possibility of compromised package sterility prior to the expiration date.

    Action

    All consignees were notified by a faxed Recall Notice letter beginning on 6/16/2008. Customers were asked to return all unused product for immediate replacement with units that have a protective barrier within the tray packaging. The firm cautioned customers to visually inspect packaging before use. Follow-up phone calls will be made the following week.

    Distribution

    Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.

    Quantity

    300,000 units.