Scholly Fiberoptic Gmbh: 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

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide Foreign: Japan, South Korea Quantity: 98 units Lot/code info: UDI-DI: 04250480106617 Lot Number: 141980

UPC codes

04250480106617

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.