Z-0713-2025 Class I Ongoing
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
- 34 units
Product Description
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), 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: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125