BEUDAMED
    FDA Enforcement Class II Terminated

    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

    Recall: Z-1868-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1868-2018
    Event ID
    79886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 11, 2018
    Classification Date
    May 14, 2018
    Termination Date
    March 9, 2022
    Address
    Pforzheimer Str. 32, Knittlingen, N/A, Germany

    Description

    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

    Reason

    Tube ends may be mixed up.

    Code Info

    Lot numbers: 32062417, 32133317

    Distribution

    Worldwide Distribution

    Quantity

    1710 units