Device product
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
Z-0299-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146 units
- Official record key
device-enforcement:Z-0299-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10174717110880, Lot Numbers: 91522, exp 2/7/2023; 91118, exp 10/18/2023; 91705, exp 12/30/2023; 92034, exp 1/26/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.