BEUDAMED
    FDA Enforcement Class I Ongoing

    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

    Recall: Z-0713-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0713-2025
    Event ID
    95770
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Trokamed GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    November 27, 2024
    Classification Date
    January 10, 2025
    Address
    Kleine Breite 17, Geisingen, N/A, Germany

    Description

    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

    Reason

    If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

    Code Info

    REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125

    Distribution

    US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

    Quantity

    34 units