FDA recall Z-0620-2024
ROi CPS LLC · Class I · device
Product
regard Operative LAP, Item Number 800943001; surgical convenience kit
Reason for recall
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Distribution
US distribution to Louisiana
Key facts
- Status
- Terminated
- Initiation date
- 2023-12-18
- Report date
- 2024-01-24
- Termination date
- 2024-10-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0620-2024