BEUDAMED
    FDA Recall Terminated

    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

    Recall: Z-2384-2021 · Initiated June 28, 2021

    Recall

    Recall Number
    Z-2384-2021
    Event Number
    88396
    FEI Number
    3017398927
    Product Code
    LXC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 28, 2021
    Terminated
    July 25, 2022
    Address
    MY01 INC. 400 De Maisonneuve Blvd W, Montreal Canada Suite 700

    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.

    Action

    A Medical Device Advisory Notice dated 6/28/21 was sent to customers. Clinicians Responsibilities/ Actions required: 1. Review this notification for awareness of the contents 2. Identify and quarantine any unused affected products in your inventory for return to MY01 Inc. Contact Customer Success team by phone (+1 (855) 292-6901) or email ([email protected]) to arrange for your replacements. 3. There are no specific patient monitoring instructions related to this voluntary product removal that are recommended beyond your existing follow up schedule. 4. Complete Attachment 1- Certificate of acknowledgement and email to [email protected] by 07-Jul-2021. 5. Include a copy of Attachment 1- Certificate of acknowledgement with product to be returned. Please use the return shipping label (to be provided by MY01 Inc.), please return affected product to: Regulatory Affairs and Quality Management MY01 Inc. 400 Maisonneuve Boulevard West, Suite 700, Montreal, Quebec, Canada H3A 1L4 6. Retain a copy of this document and Attachment 1- Certificate of acknowledgement with your records. 7. If you have further questions or concerns after reviewing this notice, please call the customer service team at 1-855-292-6901. Alternatively, your questions may be emailed to: [email protected] Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep MY01 Inc. informed of any adverse events associated with this by emailing [email protected] or call +1(855)-292-6901.

    Distribution

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

    Quantity

    37 units