Device product
regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit
Z-0295-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 258 kits
- Official record key
device-enforcement:Z-0295-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717110767, Lot Numbers: 92051, exp 7/1/2023; 91671, exp 1/29/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.