Z-2384-2021Class II

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

Name: Z-2384-2021 MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Creator: My01, Inc.
Published: 2021-06-28
License: https://open.fda.gov/license/

MY01, Inc. / initiated 2021-06-28 / Terminated / root cause: manufacturing process

FDA source

MY01, INC. began a recall of MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 on 2021-06-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2384-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-28
Posted: 2021-08-27
Terminated: 2022-07-25
Recalling firm: MY01, Inc.
Product: MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Product code: LXC Monitor, Pressure, Intracompartmental
Reason for recall: 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 tag: manufacturing process
FDA 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 ([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.
Quantity in commerce: 37 units
Distribution: US Nationwide distribution in the states of MD, OH, CA, NY.
Product codes and lots: Lot Numbers: 9448532 9448838 9448979 9449000 9449237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2384-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2384-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-27

Product code LXC

K210525UnclassifiedMY01 Continuous Compartmental Pressure MonitorMY01, Inc. / cleared 2021-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)