Device product
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
Z-0292-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 kits
- Official record key
device-enforcement:Z-0292-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10174717108863, Lot Numbers: 91577, exp 2/7/2023; 91382, exp 12/7/2023
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.