medical Class II Updated 2021-09-08

MY01, INC. recalls MY01 Continuous Compartmental Pressure Monitor, Reference Nu

Recalled Product

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 9448532 9448838 9448979 9449000 9449237
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →