BEUDAMED
    FDA Enforcement Class II Terminated

    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    Recall: Z-1885-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1885-2020
    Event ID
    85204
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northgate Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2020
    Initiation Date
    March 10, 2020
    Classification Date
    May 4, 2020
    Termination Date
    February 2, 2021
    Address
    1591 Scottsdale Ct, N/A, Elgin, IL, 60123-9361, United States

    Description

    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    Reason

    Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

    Code Info

    NTI Catalog Number 72-00198-0.

    Distribution

    US Nationwide distribution. No governmental.

    Quantity

    1238 boxes. 3 units per box.