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Trokamed GmbH recalls Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Recalled January 22, 2025 · FDA recall Z-0713-2025 · Trokamed
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. · FDA Class I
Units
34 units
Sold at
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Description
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.
Product
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Manufacturer(s)
Trokamed GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →