BEUDAMED
    FDA Enforcement Class II Terminated

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    Recall: Z-1783-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1783-2020
    Event ID
    85327
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Medical Devices Pvt. Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    March 17, 2020
    Classification Date
    April 23, 2020
    Termination Date
    October 25, 2024
    Address
    Plot No 251, Imt Manesar, Gurgaon, N/A, N/A, India

    Description

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    Reason

    Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

    Code Info

    Lot Numbers: V18007422 V18010291 V18023106 V18023107 V18023108 V18023109 V18025115 V18025117 V18025118 V18025119 V18026073 V18037032 V18026072 V18035228 V18035229 V18036131 V18037031 V18037033 V18037938 V19001678 V19001679 V19002478 V19002479 V19002480 V19013333 V19025876 V19026564 V19027234 V19027235 V19016726

    Distribution

    Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.

    Quantity

    52566