MY01, INC. recalls MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

Recall date

June 28, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2384-2021

FDA classification

Class II

Brand / firm

MY01, INC.

Sold / distributed

US Nationwide distribution in the states of MD, OH, CA, NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001