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Scholly Fiberoptic Gmbh
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Scholly Fiberoptic Gmbh and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-08-16FDA-DeviceClass IIUroLift 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
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.
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