FDA-Device2025-01-22Class I
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
Hazard
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.
Sold states
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Affected count
42 units
Manufactured in
Kleine Breite 17, Geisingen, Germany
Products
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2025Don't want to check this manually?
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