Trokamed GmbH: Device Recall
Recall #Z-0715-2025 · 11/27/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0715-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Trokamed GmbH
- Status
- Ongoing
- Date Initiated
- 11/27/2024
- Location
- Geisingen, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
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.
Product Description
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Distribution Pattern
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Other Recalls by Trokamed GmbH
- Class I: Dangerous 11/27/2024
- Class I: Dangerous 11/27/2024
- Class I: Dangerous 11/27/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.