BEUDAMED
    FDA Enforcement Class III Terminated

    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

    Recall: Z-0202-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0202-2023
    Event ID
    90926
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canadian Hospital Specialties
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 23, 2022
    Initiation Date
    August 19, 2022
    Classification Date
    November 11, 2022
    Termination Date
    March 20, 2023
    Address
    2760 Brighton Rd, N/A, Oakville, N/A, N/A, Canada

    Description

    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

    Reason

    Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.

    Code Info

    UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01

    Distribution

    US

    Quantity

    9100 units