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
This recall is currently active, issued August 9, 2023. It was issued by Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany.
- Recall Initiated
- June 23, 2023
- Posted
- August 9, 2023
- Recall Number
- Z-2364-2023
- Quantity
- 98 units
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI-DI: 04250480106617 Lot Number: 141980
Root Cause
Process control
Action Taken
SCHOLLY FIBEROPTIC GMBH initiated Recall Plan Letter to Users, Importers and Distributors . The US Distributor- Teleflex (parent company of NeoTract) notified on June 23, 2023 to forward the notification letter to their customers. Letter states reason for recall, health risk and action to take: Review this Field Safety Notice in its entirety and ensure that all users of the above-mentioned product in your organization and other concerned persons are informed about this Field Safety Notice. 2. If you are a distributor, please forward this correction notification to your customers. 3. Identify, quarantine and return affected devices. 4. Do not use affected devices anymore. 5. Exchange devices from the above-mentioned batches, which are currently in use. 6. Confirm receipt of this information by filling in the attached reply form and returning it to the indicated e-mail address. E-Mail: vigilance@schoelly.de