| TGA Action ID |
RC-2026-RN-00633-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
S7XTRA 200 Tub Wipes
Product Code: S7XW200
Batch: 393253
Expiry: 01/2029 |
| ARTG Number |
463988 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
Dirt and debris have contaminated a small quantity of tubs in Batch: 393253, expiry: 01/2029. The debris appears as small dark spots and smears on the inner sides of the tub and the wipes material.
Laboratory analysis has confirmed the debris is non-microbiological and consists of physical dust/dirt particulates. Investigation has determined the debris were introduced during pre-production due to human error in materials handling processes.
There is no expected health consequences for users exposed to the affected product, however use may transfer dirt/debris onto surfaces. |
| Instructions for Customers/Users |
Customers are to:
- Inspect and quarantine affected stock on hand to prevent further use.
- Dispose of affected products according to the Instructions For Use and provide evidence of disposal to Steri-7.
- Alternatively, return affected stock on hand with the completed Response Form to Steri-7.
- Contact Steri-7 to arrange replacement stock. |
| Action Commencement Date |
19/08/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 8209 3846 - Phillip Robinson |