| TGA Action ID |
RC-2025-RN-00364-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Endox A
Product code: 160680
Batches: A59612, A59643, A59670
Expiry date: Apr 2026
Manufacture date: Feb 2025 |
| ARTG Number |
409191 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Affected bottles may become pressurised increasing the risk of spills/splashes when opened. In rare cases the bottle may experience a pressure burst. Affected bottles are readily identifiable by bulging on the long edge of the bottle.
It is suspected metal contamination caused the rate of oxygen liberation to exceed the vent capacity of the cap, increasing the pressure within the bottle sufficiently to cause swelling.
Skin contact with spilled product causes burns and temporary localised bleaching. Contact with eyes causes serious eye damage which, if left untreated, may cause permanent vision impairment. Vapours from spilled product may cause respiratory irritation. Combustible materials (e.g. cardboard, cloth) contacted by the product may spontaneously ignite.
Investigation did not find a decrease in active ingredient concentration in a comparable product. There is minimal risk to patients from endoscopes reprocessed using potentially affected bottles. |
| Instructions for Customers/Users |
Customers are to:
- Isolate any bottles exhibiting swelling. If possible, place affected stock in a bunded storage area or large plastic tub to contain potential spillage.
- Contact Whiteley for advice on return or disposal of affected containers. Product is a dangerous good and may require engagement of specialist waste services.
-Replacement stock will be provided.
This action has been closed out on 01/05/2026. |
| Action Commencement Date |
2/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 833 566 - Whiteley Customer Service |