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Scholly Fiberoptic Gmbh recalls UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cyst
Recalled August 16, 2023 · FDA recall Z-2364-2023 · Scholly Fiberoptic
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. · FDA Class II
Units
98 units
Sold at
Nationwide Foreign: Japan, South Korea
Description
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.
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
Manufacturer(s)
Scholly Fiberoptic Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →