Class I

Medical Device Recall: Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH · November 27, 2024

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. .

States Affected

IN, PA

Quantity Affected

53 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0715-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.