| TGA Action ID |
RC-2026-RN-00853-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Schiffa Skin Lesion Kit SCP100 & SCP111
Batch Number: MED20260922 |
| ARTG Number |
507910 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Schiffa Health received a complaint that the inner sterilisation strip did not adequately change colour. There is the potential that product supplied is not sterile.
There is a risk of infection if a non-sterile instrument is used on a patient during a skin lesion removal. Schiffa Health has not received any reports of adverse reactions to date. |
| Instructions for Customers/Users |
Customers are to:
- Immediately inspect and quarantine affected stock on hand to prevent further use or distribution.
- Contact Schiffa Health on 1300 611 511 or email sales@schiffa.com.au for further instructions and discuss replacement options. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 611 511 - Schiffa Health |