Device product
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Z-0310-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 228 kits
- Official record key
device-enforcement:Z-0310-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717113119, Lot Numbers: 90987, exp 12/28/2023; 91804, exp 3/18/2024; 92715, exp 6/6/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.