BEUDAMED
    FDA Enforcement Class II Terminated

    ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).

    Recall: Z-1147-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1147-2021
    Event ID
    87231
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northgate Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 3, 2021
    Initiation Date
    January 15, 2021
    Classification Date
    February 24, 2021
    Termination Date
    October 31, 2022
    Address
    1591 Scottsdale Ct, N/A, Elgin, IL, 60123-9361, United States

    Description

    ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).

    Reason

    An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

    Code Info

    Lot Codes: 9855JEG to 93879JEG

    Distribution

    US Nationwide distribution in the states of FL and OH.

    Quantity

    25 units