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U.S. Department of Health and Human Services

Class 2 Device Recall MY01 Continuous Compartmental Pressure Monitor

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  Class 2 Device Recall MY01 Continuous Compartmental Pressure Monitor see related information
Date Initiated by Firm June 28, 2021
Create Date August 27, 2021
Recall Status1 Terminated 3 on July 25, 2022
Recall Number Z-2384-2021
Recall Event ID 88396
510(K)Number K210525  
Product Classification Monitor, pressure, intracompartmental - Product Code LXC
Product MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Code Information Lot Numbers: 9448532 9448838 9448979 9449000 9449237
Recalling Firm/
Manufacturer		 MY01, INC.
400 De Maisonneuve Blvd W Suite 700
Montreal Canada
Manufacturer 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.
FDA Determined
Cause 2		 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 acknowledgement and email to help@my01.io 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: help@my01.io 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 help@my01.io or call +1(855)-292-6901.
Quantity in Commerce 37 units
Distribution US Nationwide distribution in the states of MD, OH, CA, NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXC and Original Applicant = MY01 Inc.
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