BEUDAMED
    FDA Enforcement Class II Terminated

    Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY 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-2764-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-2764-2018
    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 12FR, Catalogue Number 102201101280TY 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

    S17000808, S17000943, S17000946, S17002077, S17001347, S17002197, S17002979, S17003351, S17003439, S17003347, S17003350, S17004190, S17004479, S17004736, S17000809, S17000660, S17001348, S17001349, S17005948, S17005949

    Distribution

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

    Quantity

    47520