BEUDAMED
    FDA Recall Terminated

    Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.

    Recall: Z-1543-2013 · Initiated June 4, 2013

    Recall

    Recall Number
    Z-1543-2013
    Event Number
    65374
    Firm
    Utah Medical Products, Inc
    FEI Number
    1718873
    Product Code
    DRS
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 4, 2013
    Posted
    June 13, 2013
    Terminated
    September 19, 2013
    Address
    7043 South 300, West Midvale, UT, 84047

    Description

    Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.

    Reason

    Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.

    Action

    Utah Medical Products (UTMD) sent a Recall Notice letter dated June 3, 2013 via fax and email to all affected customers and will be completing follow up telephone calls by June 7, 2013. The letter identified the affected product, problem, health risk, and actions to be taken. UTMD instructed customers to locate and return affected products for exchange. For questions call Customer Service at 800-533-4984.

    Distribution

    Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.

    Quantity

    1,800 kits