| TGA Action ID |
RC-2026-RN-00012-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ion Endoluminal System - Vision Probe Bag 10 pack
Part Number: 490127
Batch Numbers: DM01241638, DM01243720, DM01244230, DM01252338, DM01252527, DM01252828 |
| ARTG Number |
471706 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Some Vision Probe Bags used with the Ion Endoluminal System may have compromised or incomplete sterile pouch seals due to air trapped inside the bag during manufacturing and sterilisation. This can result in partial seal failure, creating a potential sterility breach.
This problem was identified through internal quality processes, no complaints have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Inspect the pouch seal of all affected devices listed.
- If the seal is compromised or incomplete, do not use the product and dispose of it according to their facility’s procedures. |
| Action Commencement Date |
7/01/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies |