Reported Aug 16, 2023 · Ongoing
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a…
Scholly Fiberoptic GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Scholly Fiberoptic Gmbh · Robert-Bosch-Str. 1-3 · Denzlingen, N/A · N/A
Is this the product you have?
- UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder
- ModelUL-VO
- Lot codes and dates
- UDI-DI04250480106617
- Lot Number141980
- Amount recalled
- 98 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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