BEUDAMED
    FDA Enforcement Class II Terminated

    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

    Recall: Z-1235-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1235-2022
    Event ID
    90095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northgate Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2022
    Initiation Date
    April 13, 2022
    Classification Date
    June 3, 2022
    Termination Date
    November 8, 2022
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361, United States

    Description

    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

    Reason

    Product labeled incorrectly.

    Code Info

    NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    55 probes