UroLift Visual Obturator recall: Contamination
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder.…
Why was UroLift Visual Obturator recalled?
There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.
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?
UDI-DI: 04250480106617 Lot Number: 141980
- Product
- UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder.…
- Recalling firm
- Scholly Fiberoptic Gmbh
- Quantity
- 98 units
- Distribution
- Nationwide Foreign: Japan, South Korea
- Recall date
- August 16, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)