medical Class I Updated 2025-01-22

Trokamed GmbH recalls Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-uro

Recalled Product

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), 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: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
View official government recall

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