BEUDAMED
    FDA Enforcement Class II Terminated

    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

    Recall: Z-2706-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2706-2020
    Event ID
    85863
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    July 27, 2020
    Termination Date
    June 28, 2024
    Address
    Pforzheimer Str. 32, N/A, Knittlingen, N/A, N/A, Germany

    Description

    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

    Reason

    Tube material of a smaller diameter was used.

    Code Info

    Lot Number 32324159, Model # 4170.801

    Distribution

    International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).

    Quantity

    338 sets