| TGA Action ID |
RC-2025-RN-00639-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VascuLife Angel Fiber 400µm and 600µm
Model numbers: AAIP03091404, AAIP03091408
Lot numbers: L00110790, L00109412, L00108285, L00107577, L00111405, L00111453, L00111159 |
| ARTG Number |
429311 |
| Unique Device Identifier (UDI) |
Not applicable at this time |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer, Lightguide Optics International has identified a potential problem involving distal tip separation in certain Vasculife Angel Fiber devices, dated March 10, 2025. This problem has been attributed to variability in the adhesive used for cap assemblies in specific production lots. |
| Instructions for Customers/Users |
Customers are to:
· Immediately stop using the affected product.
· Secure all remaining affected stock and the stock should be clearly separated and labelled to prevent further use or distribution.
· Be advised that Getz Healthcare Pty Ltd will coordinate the collection of the affected devices.
· Complete the “Notice of Receipt” form and return it to Getz Healthcare using the contact details provided.
· Expect replacement products to be dispatched upon receipt of the completed form.
This action has been closed out on 29/10/2025 |
| Action Commencement Date |
24/07/2025 |
| Responsible Entity |
|
| Contact Information |
02 9413 6200 - Customer Care Getz Healthcare |