Device product
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Z-1250-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 90135
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125 units
- Official record key
device-enforcement:Z-1250-2022
Official wording
Reason: Potential for the tip of the electrode to detach during use.
Code information: Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024)
Distribution pattern: Distributed to North Carolina.
Derived failure modes
-
Unknown
Potential for the tip of the electrode to detach during use.