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
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