BEUDAMED
    FDA Enforcement Class II Terminated

    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

    Recall: Z-2384-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2384-2021
    Event ID
    88396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MY01, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    June 28, 2021
    Classification Date
    August 27, 2021
    Termination Date
    July 25, 2022
    Address
    400 De Maisonneuve Blvd W Suite 700, N/A, Montreal, N/A, N/A, Canada

    Description

    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

    Reason

    There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.

    Code Info

    Lot Numbers: 9448532 9448838 9448979 9449000 9449237

    Distribution

    US Nationwide distribution in the states of MD, OH, CA, NY.

    Quantity

    37 units