Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Check against the official notice below — it lists the full affected range.
ROi CPS LLC is recalling 125 units of a CONMED sterile needle with Stealth ER electrode (Catalog No. 60-5274-944) distributed to North Carolina. The recall affects five lot numbers with expiration dates ranging from May 2023 to January 2024. The needle was intended for use in gastro bypass procedures and is identified by Item Number 800214007 and Model Number GS00367G.
The reason for the recall is a potential for the tip of the electrode to detach during use, which could create a safety hazard during medical procedures. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for the tip of the electrode to detach during use.
Reason for recall: Potential for the tip of the electrode to detach during use. Distribution: Distributed to North Carolina. Quantity: 125 units Lot/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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.