Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1250-2022
Event ID90135
Event DescriptionRegard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Product TypeDevices
DistributionDistributed to North Carolina.
Quantity125 units
Recall ReasonPotential for the tip of the electrode to detach during use.
Device Classification20220615
Device Code InfoCatalog 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 Date20220608
Recall Initiation Date20220503
Recalling FirmROi CPS LLC
Initial Notification E-Mail
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