BEUDAMED
    FDA Recall Terminated

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    Recall: Z-0073-2018 · Initiated May 24, 2017

    Recall

    Recall Number
    Z-0073-2018
    Event Number
    77367
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 24, 2017
    Terminated
    June 9, 2020
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361

    Description

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    Reason

    The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.

    Action

    Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.

    Distribution

    US Distribution to the following states : MA, NE and TN and Internationally to Canada.

    Quantity

    186