BEUDAMED
    FDA Recall 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 · Initiated January 15, 2021

    Recall

    Recall Number
    Z-1147-2021
    Event Number
    87231
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 15, 2021
    Terminated
    October 31, 2022
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361

    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.

    Action

    The firm initiated the recall on 01/15/2021 by email to its direct consignees. The notice requested the consignee cease distribution or use and return the product to NTI. It also directed the consignee to notify their customers if the product was further distributed.

    Distribution

    US Nationwide distribution in the states of FL and OH.

    Quantity

    25 units