MY01 Continuous Compartmental Pressure Monitor recall
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Why was MY01 Continuous Compartmental Pressure Monitor 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 9448532 9448838 9448979 9449000 9449237
- Product
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Recalling firm
- MY01, INC.
- Quantity
- 37 units
- Distribution
- US Nationwide distribution in the states of MD, OH, CA, NY.
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)