Recall Z-2364-2023 ยท HIH Hysteroscope (And Accessories)
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
| Date | Aug 9, 2023 (initiated Jun 23, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. Identi |
| Quantity | 98 units |
| Distribution | Nationwide Foreign: Japan, South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories Schoelly Fiberoptic GmbH, Mar 9, 2015 |