BEUDAMED
    FDA Recall Terminated

    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

    Recall: Z-1235-2022 · Initiated April 13, 2022

    Recall

    Recall Number
    Z-1235-2022
    Event Number
    90095
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 13, 2022
    Terminated
    November 8, 2022
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361

    Description

    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

    Reason

    Product labeled incorrectly.

    Action

    The firm sent out the recall notification to their consignee on 04/13/2022 via email. The firm sent out a letter as well on 04/27/2022 which instructs the consignee to cease distribution, quarantine affected units and return affected product. If the distributor further distributed the product, they are asked to notify their customers.

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    55 probes