FDA recall Z-0469-2022
ROi CPS LLC · Class II · device
Product
Regard, T AND A - Rogers, sterilized convenience kits
Reason for recall
Kits lacks rubber latex warning label.
Distribution
US Nationwide distribution in the state of MO.
Key facts
- Status
- Terminated
- Initiation date
- 2021-11-30
- Report date
- 2022-01-19
- Termination date
- 2023-08-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2022