MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

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.

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.