BEUDAMED
    FDA Enforcement Class II Ongoing

    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient

    Recall: Z-0357-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0357-2023
    Event ID
    91087
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    November 1, 2022
    Classification Date
    December 2, 2022
    Address
    777 West St, N/A, Mansfield, MA, 02048-1122, United States

    Description

    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient

    Reason

    Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

    Code Info

    UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

    Distribution

    Nationwide

    Quantity

    N/A