Device product
regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
Z-0317-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166 kits
- Official record key
device-enforcement:Z-0317-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717104742, Lot Numbers: 91265, exp 1/20/2024; 92541, exp 5/17/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.