| TGA Action ID |
RC-2025-RN-00130-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FemTouch Disposable Tips
Catalogue numbers: AC-2005209, AC-2005211
ARTG 315263
(Urogenital surgical laser system beam guide, single-use (Cancelled on April 2024)).
|
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices.
Lumenis Be ANZ Pty Ltd on behalf of Lumenis Australia PTY Ltd., is conducting a recall of FemTouch Disposable Tips.
No injuries or safety related adverse events were reported.
This was not notified to the TGA Recalls Section prior to undertaking the action. |
| Instructions for Customers/Users |
Customers are to:
- inspect stock and quarantine any FemTouch Disposable Tips to prevent further use
- return affected stock with the completed response form |
| Action Commencement Date |
20/02/2025 |
| Responsible Entity |
|
| Contact Information |
Tracey.Cannon@lumenis.com - Tracey Cannon |