Device product
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
Z-0287-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-0287-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717109914, Lot Numbers: 91329, exp 11/27/2022
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.