FDA-Device2021-09-08Class II
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
MY01, INC.
Hazard
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.
Sold states
US Nationwide distribution in the states of MD, OH, CA, NY.
Affected count
37 units
Manufactured in
400 De Maisonneuve Blvd W Suite 700, N/A, Montreal, N/A, Canada
Products
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2384-2021Don't want to check this manually?
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