UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cysto
FDA device recall Z-2364-2023 · posted 2023-08-09 · Open, Classified
Recall details
- Recalling firm
- Scholly Fiberoptic Gmbh
- 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.
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HIH
- Quantity affected
- 98 units
- Distribution
- Nationwide Foreign: Japan, South Korea
- Date initiated
- 2023-06-23
- Date posted
- 2023-08-09
- Location
- Denzlingen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Schoelly Cystoscopes/Hysteroscopes and Accessories (K150158) | Schoelly Fiberoptic GmbH | 2015-03-09 |