Reported Jun 15, 2022 · Terminated
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/…
ROi CPS LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
- Regard Item Number800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 60-5274-944— 800214007— GS00367G— — 10194717101024UDI/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) - Amount recalled
- 125 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for the tip of the electrode to detach during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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