BEUDAMED
    FDA Enforcement Class II Terminated

    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

    Recall: Z-1148-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1148-2021
    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

    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

    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: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK

    Distribution

    US Nationwide distribution in the states of FL and OH.

    Quantity

    45 units