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MY01, INC. recalls MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Recalled September 8, 2021 · FDA recall Z-2384-2021 · MY01
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. · FDA Class II
Units
37 units
Sold at
US Nationwide distribution in the states of MD, OH, CA, NY.
Description
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.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Manufacturer(s)
MY01, INC.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →