Reported Jan 22, 2025 · Ongoing
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Trokamed GmbH · Kleine Breite 17 · Geisingen · N/A
Is this the product you have?
Sheath18 Fr160
- mm (REFWA2PS18L), gastroenterology-urology endoscopic access overtube
- Lot codes and dates
- REFWA2PS18L
- UDI-DI04251303810872
- Lot Numbers154214
- Amount recalled
- 102 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Using this product could cause serious injury, illness or death — stop using it now.
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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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