Recall Z-0714-2025— Trokamed GmbH
Class I · Ongoing
Class I FDA medical device recall by Trokamed GmbH, initiated 2024-11-27. It names one FDA 510(k) clearance: K200770. Product: Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.. 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..
- Recalling firm
- Trokamed GmbH
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-11-27
- Firm location
- Geisingen, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.