BEUDAMED
    FDA Enforcement Class II Terminated

    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    Recall: Z-2767-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-2767-2018
    Event ID
    80641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Silicone, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    June 21, 2018
    Classification Date
    September 20, 2018
    Termination Date
    October 25, 2024
    Address
    Degania Bet, N/A, Dganya Bet, N/A, N/A, Israel

    Description

    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    Reason

    The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

    Code Info

    S17002333, S17002452, S17002892, S17003578, S17005045, S17003306, S17005046, S17007065, S17005298, S17000279, S17000280, S17000837, S17007171, S18001346, S17000333

    Distribution

    Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

    Quantity

    12532