| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00230-1 |
| Product Name/Description |
Endosee Advance Cannula Device (REF: CS ESPX5)
Lot number: 334889
Expiry date: 05/09/2025
ARTG 318924
(Endotherapeutics Pty Ltd - Hysteroscope, flexible, video) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Endotherapeutics Pty Ltd has identified a problem when affected cannulas are connected to the Endosee Advance Display Module, an error message is displayed instructing the user to replace the cannula.
The single-use disposable cannula consists of a camera and LED light source at the distal end to illuminate the area for visualisation and image/video capture. Risk to patient health is negligible. Possible risk posed is a delay in procedure.
There have been no complaints with adverse reactions for the affected lots of cannulas.
This recall action was undertaken prior to TGA notification. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customer to set aside any remaining inventory of the affected item and to return it to the sponsor. |
| Contact Information |
info@endotherapeutics.com.au - Endotherapeutics Pty Ltd |