Home / Recalls / Trokamed GmbH / Z-0716-2025

Z-0716-2025 Class I Ongoing

Recalled by Trokamed GmbH — Geisingen

Recall Details

Product Type: Devices
Report Date: January 22, 2025
Initiation Date: November 27, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 102 units

Product Description

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

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 Pattern

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

Code Information

REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214