Recall Z-2384-2021— MY01, INC.
Class II · Terminated
Class II FDA medical device recall by MY01, INC., initiated 2021-06-28, terminated 2022-07-25. It names one FDA 510(k) clearance: K210525. Product: MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001. 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..
- Recalling firm
- MY01, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-28
- Terminated
- 2022-07-25
- Firm location
- Montreal, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.