Sheath recall
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Why was Sheath 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125
- Product
- Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
- Recalling firm
- Trokamed GmbH
- Quantity
- 34 units
- Distribution
- US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
- Recall date
- January 22, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)