| TGA Action ID |
RC-2025-RN-00713-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
I/A System, single use handpieces BSD 515
Lot Number: FBD82
Expiry dates: June 2026 and June 2027 |
| ARTG Number |
277423 |
| Unique Device Identifier (UDI) |
07640137450038 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
During internal tests, a reduced irrigation flow was observed for two BSD 515 irrigation handpieces from lot FBD82.
Further analysis showed that traces of solid and biocompatible adhesive, which is used in production to glue the cannula to the handle, led to a constriction in one section of the cannula i.e. a small section with a reduced diameter.
To date, there are no reports of any health impact on patients. However, the duration of the irrigation/aspiration process may be prolonged. The performance of the irrigation handpiece may feel unexpected for surgeons. |
| Instructions for Customers/Users |
Customers are to:
- Immediately quarantine lot FBD82 on hand to prevent further use.
- Return affected stock with the completed response form to Faro Care.
- Contact Faro Care to arrange for replacements.
This action has been closed out on 02/06/2026 |
| Action Commencement Date |
15/08/2025 |
| Responsible Entity |
|
| Contact Information |
0456 709 555 - Rahul Leekha, Faro Care |