BEUDAMED
    FDA Enforcement Class II Terminated

    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

    Recall: Z-0809-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0809-2020
    Event ID
    84510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Silicone, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2020
    Initiation Date
    December 2, 2019
    Classification Date
    January 13, 2020
    Termination Date
    October 22, 2020
    Address
    Degania Bet, Dganya Bet, N/A, Israel

    Description

    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

    Reason

    Temperature deviation did not meet release specifications

    Code Info

    Lot Number: V18046701

    Distribution

    US Distribution to IL

    Quantity

    2080 units