FDAJune 23, 2023device
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
scholly fiberopticscholly
UPCs
04250480106617
Recall history
No related federal recalls on record for this brand yet.
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