Trokamed GmbH: Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

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.

Details from the source

Reason for recall: 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. Distribution: US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. . Quantity: 53 units Lot/code info: REF: WA2PS18S; UDI-DI: 04251303810865; Lot Numbers: 159825

UPC codes

04251303810865

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.