BEUDAMED
    FDA Recall Terminated

    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    Recall: Z-0414-2017 · Initiated September 27, 2016

    Recall

    Recall Number
    Z-0414-2017
    Event Number
    75491
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DRS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 27, 2016
    Posted
    November 15, 2016
    Terminated
    July 11, 2017
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    Reason

    ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

    Action

    ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 2, or e-mail the following address: [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to [email protected]. Customers with questions were instructed to call 866-829-9025.

    Distribution

    Nationwide Distribution

    Quantity

    20 units