BEUDAMED
    FDA Enforcement Class II Ongoing

    Trumpet, Needle Guide, Cat# TMS-200

    Recall: Z-1460-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1460-2024
    Event ID
    94135
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Technicality Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 10, 2024
    Initiation Date
    January 31, 2024
    Classification Date
    April 2, 2024
    Address
    661 S Addison Rd, Addison, IL, 60101-4648, United States

    Description

    Trumpet, Needle Guide, Cat# TMS-200

    Reason

    The Ring on the Trump Needle Guide can detach when excessive pressure is applied.

    Code Info

    Lot Numbers: 22190 & 22497

    Distribution

    US Nationwide distribution in the state of Illinois.

    Quantity

    20000 units