| TGA Action ID |
RC-2026-RN-00639-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Steriking Paper-Laminate Pouches
Multiple descriptions, item codes and batches |
| ARTG Number |
125851, 373592 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Grey water marks may become visible on the paper surface following steam sterilisation. The marks are not visible prior to sterilisation and their occurrence is variable. The problem has been associated with specific paper batches supplied by one material supplier. The grey water marks are cosmetic in nature and do not indicate a defect in the sterile barrier. |
| Instructions for Customers/Users |
Wipak has discontinued the use of the affected material from the supplier.
Customers are to:
- Continue to use affected Steriking paper-laminate pouches in accordance with the approved IFU and established CSSD procedures.
- Inspect packaging prior to use to confirm it remains intact.
- Note that grey water marks observed on affected batches do not indicate a failure of the CSSD sterilisation process.
- Consider an item unsterile if any uncertainty regarding sterility remains following those checks. |
| Action Commencement Date |
16/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 735 292 - Customer Care Team |