Device product
regard Operative LAP, Item Number 800943001; surgical convenience kit
Z-0620-2024
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 93653
- Status
- Terminated
- Classification
- Class I
- Quantity
- 345 units
- Official record key
device-enforcement:Z-0620-2024
Official wording
Reason: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Code information: UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
Distribution pattern: US distribution to Louisiana
Derived failure modes
-
Unknown
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.