Geisingen, Germany
Trokamed GmbH recalls
1 recall recorded since 2018, most recently on 27 November 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 27 November 2024
- Reason
- 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. .
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0715-2025, Z-0714-2025, Z-0713-2025, Z-0716-2025
- Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
- Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
- Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
- Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.