Trokamed GmbH recalls Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-uro
Recalled Product
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Hazard / Issue
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.
Issued by
FDA
Affected States: PA
Lot/Code Info: REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125
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