BEUDAMED
    FDA Recall Terminated

    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

    Recall: Z-2744-2020 · Initiated June 23, 2020

    Recall

    Recall Number
    Z-2744-2020
    Event Number
    86035
    Firm
    Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany
    FEI Number
    3004857377
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 23, 2020
    Terminated
    August 21, 2020

    Description

    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

    Reason

    The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.

    Action

    Sutter Medizintechnik issues a recall letter via email dated July 2020. This letter instructs customers/distributors to do the following: Please further notify anyone you have distributed the product to. Please complete and return the acknowledgement and receipt form. Please exchange the IFU inside the package. You may follow the instruction as shown in the pictures. As a precautionary measure, do NOT use sharp tools such as forceps and do not perform the exchange with sharp fingernails.

    Distribution

    US Nationwide distribution including in the states of MD, NJ, MI, NC, IN, CA, AL, WA, OK, MS, GA, FL, SC, TX, CO, MN, MO, KS.

    Quantity

    1337 units