BEUDAMED
    FDA Enforcement Class II Terminated

    CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The 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.-75

    Recall: Z-0530-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0530-2017
    Event ID
    75491
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    September 27, 2016
    Classification Date
    November 15, 2016
    Termination Date
    July 11, 2017
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The 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.-75

    Reason

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

    Code Info

    3274948 3281379 3293483

    Distribution

    Nationwide Distribution

    Quantity

    105 units