BEUDAMED
    FDA Enforcement Class II Terminated

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    Recall: Z-0512-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0512-2020
    Event ID
    83587
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rocket Medical Plc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    August 1, 2019
    Classification Date
    November 26, 2019
    Termination Date
    November 2, 2021
    Address
    Industrial Estate Sedling Road Wear Indu, Tyne & Wear, Washington, N/A, United Kingdom

    Description

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    Reason

    A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

    Code Info

    All lots (UDI): 05055270913678

    Distribution

    Nationwide

    Quantity

    1081