MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

Reason: 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.

Code information: Lot Numbers: 9448532 9448838 9448979 9449000 9449237

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