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Recall Observatory FDA recall evidence

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

May 03, 2022

Class II

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

    reason.no_named_rule · v1.0.0

    Potential for the tip of the electrode to detach during use.