Recall Z-2384-2021 ยท LXC Monitor, Pressure, Intracompartmental
MY01, INC.
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
| Date | Jun 28, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| 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 (help@my01.io) 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 acknowl |
| Quantity | 37 units |
| Distribution | US Nationwide distribution in the states of MD, OH, CA, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210525 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., Apr 22, 2021 |