MY01, INC. Recall 88396
Description: MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
MY01, INC. Recall 88396 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2384-2021 |
| Event ID | 88396 |
| Event Description | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of MD, OH, CA, NY. |
| Quantity | 37 units |
| Recall 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. |
| Device Classification | 20210908 |
| Device Code Info | Lot Numbers: 9448532 9448838 9448979 9449000 9449237 |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20210628 |
| Recalling Firm | MY01, INC. |
| Initial Notification | Letter |
| Similar To |