BEUDAMED
    FDA Enforcement Class II 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 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1543-2013
    Event ID
    65374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Utah Medical Products, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 19, 2013
    Initiation Date
    June 4, 2013
    Classification Date
    June 13, 2013
    Termination Date
    September 19, 2013
    Address
    7043 South 300 West, N/A, Midvale, UT, 84047, United States

    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.

    Code Info

    Part number DPT-248A, lot number 1122508.

    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