Z-2384-2021 Class II Terminated
FDA device recall Z-2384-2021 was initiated by MY01, INC. on June 28, 2021 and is designated Class II. 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 req… The recall status is terminated (terminated July 25, 2022). Affected quantity: 37 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- June 28, 2021
- Termination Date
- July 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 units
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.
Distribution Pattern
US Nationwide distribution in the states of MD, OH, CA, NY.
Code Information
Lot Numbers: 9448532 9448838 9448979 9449000 9449237