Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Reported: January 22, 2025 Initiated: November 27, 2024 #Z-0715-2025
Product Description
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), 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.
Details
- Recalling Firm
- Trokamed GmbH
- Units Affected
- 53 units
- Distribution
- US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
- Location
- Geisingen
Frequently Asked Questions
What product was recalled? ▼
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.. Recalled by Trokamed GmbH. Units affected: 53 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Critical. Recall number: Z-0715-2025.
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