Reported Sep 8, 2021 · Terminated
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
My01, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MY01, INC. · 400 De Maisonneuve Blvd W Suite 700 · Montreal, N/A · N/A
Is this the product you have?
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Lot codes and dates
- Lot Numbers9448532 9448838 9448979 9449000 9449237
- Amount recalled
- 37 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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