FDA recall Z-2384-2021

Product

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-06-28

Report date

2021-09-08

Termination date

2022-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montreal, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2384-2021