BEUDAMED
    FDA Recall Terminated

    Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    Recall: Z-1883-2020 · Initiated March 10, 2020

    Recall

    Recall Number
    Z-1883-2020
    Event Number
    85204
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 10, 2020
    Posted
    March 24, 2020
    Terminated
    February 2, 2021
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361

    Description

    Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    Reason

    As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

    Action

    Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".

    Distribution

    US Nationwide distribution. No governmental.

    Quantity

    298 boxes. 3 units per box