FDAJune 28, 2021device
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
my01
Recall history
No related federal recalls on record for this brand yet.
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