Montreal, N/A, Canada
MY01, INC. recalls
1 recall recorded since 2018, most recently on 28 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 June 2021
- Terminated
- 25 July 2022
- 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.
- Distribution
- US Nationwide distribution in the states of MD, OH, CA, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2384-2021
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.