FDA recall Z-0716-2025

Product

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

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

Key facts

Status

Ongoing

Initiation date

2024-11-27

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Geisingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2025