BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1868-2018 · Initiated March 11, 2018

    Recall

    Recall Number
    Z-1868-2018
    Event Number
    79886
    Firm
    Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany
    FEI Number
    3002808001
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 11, 2018
    Terminated
    March 9, 2022

    Description

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

    Reason

    Tube ends may be mixed up.

    Action

    The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to [email protected].

    Distribution

    Worldwide Distribution

    Quantity

    1710 units