Device product
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Z-0289-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 164 units
- Official record key
device-enforcement:Z-0289-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717108849, Lot Numbers: 91281, exp 5/28/2023; 91103, exp 10/11/2023
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.