Recall Z-0715-2025 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Trokamed GmbH
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
| Date | Jan 10, 2025 (initiated Nov 27, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | On November 27, 2024, a "URGENT SAFETY FIELD NOTICE" email was sent to the distributor. Actions to be taken: - Inform the medical personnel using the product about the update of the IFU: 1. The Instructions for Use has to be exchanged. 2. Complete the enclosed acknowledgement of receipt and email to anna.speker@trokamed.de by the provided date. - Please be informed that the assumption of risks is on your behalf when you will not send back the acknowledgement by the provided date. Disclosure of the information described herein: Please ensure in your organization that all users of the above-men |
| Quantity | 53 units |
| Distribution | US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200770 | Mini PCNL-System Trokamed GmbH, Jul 30, 2021 |