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
Reported: August 16, 2023 Initiated: June 23, 2023 #Z-2364-2023
Product Description
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
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.
Details
- Recalling Firm
- Scholly Fiberoptic Gmbh
- Units Affected
- 98 units
- Distribution
- Nationwide Foreign: Japan, South Korea
- Location
- Denzlingen, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Scholly Fiberoptic Gmbh. Units affected: 98 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2364-2023.
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