medical Class II Updated 2023-08-16

Scholly Fiberoptic Gmbh recalls UroLift Visual Obturator, 20Ch-The visual obturator is used

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04250480106617 Lot Number: 141980
View official government recall

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