FDA recall Z-0299-2023
ROi CPS LLC · Class II · device
Product
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
Reason for recall
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Distribution
LA, MO, NC, FL
Key facts
- Status
- Terminated
- Initiation date
- 2022-10-20
- Report date
- 2022-11-30
- Termination date
- 2026-04-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0299-2023