BEUDAMED
    FDA Enforcement Class II Terminated

    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

    Recall: Z-0354-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0354-2020
    Event ID
    83926
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Monarch Medical Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2019
    Initiation Date
    October 1, 2019
    Classification Date
    November 8, 2019
    Termination Date
    February 10, 2026
    Address
    2137 South Blvd Ste 300, N/A, Charlotte, NC, 28203-5189, United States

    Description

    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

    Reason

    Product was distributed prior to approval or clearance from FDA.

    Code Info

    versions: v 1.7.1, 1.7.4, 1.7.5

    Distribution

    SC, IL IN, CA

    Quantity

    6 units