ROi CPS LLC Recall 90135
Description: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
ROi CPS LLC Recall 90135 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1250-2022 |
| Event ID | 90135 |
| Event Description | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm |
| Product Type | Devices |
| Distribution | Distributed to North Carolina. |
| Quantity | 125 units |
| Recall Reason | Potential for the tip of the electrode to detach during use. |
| Device Classification | 20220615 |
| Device Code Info | 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) |
| Center Classification Date | 20220608 |
| Recall Initiation Date | 20220503 |
| Recalling Firm | ROi CPS LLC |
| Initial Notification | |
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