| TGA Action ID |
RC-2026-RN-00445-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ortho Arch Intraoral Elastics
Multiple descriptions, product codes and lot numbers |
| ARTG Number |
341575 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The product packaging incorrectly states the temperature storage range as 38–76 degrees Celsius, whereas this corresponds to the Fahrenheit scale. Future lots will be updated to reflect the correct temperature range of 3–24 degrees Celsius on the labelling.
Affected products were distributed between 1 April 2025 and 30 April 2026. |
| Instructions for Customers/Users |
Customers are to be aware of the correct temperature range and continue using the product.
This action has been finalised on 27/10/2026. |
| Action Commencement Date |
11/06/2026 |
| Responsible Entity |
|
| Contact Information |
0438 803 410 - Henry Schein Customer Care |