| TGA Action ID |
RC-2025-RN-00900-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
AeroSCAR Silicone Scar Sheet
Product Codes: ASGS12 & ASGS20
Lot Numbers: 235354, 256165
Manufacturing dates: 2023-02, 2025-07 |
| ARTG Number |
428731 |
| Unique Device Identifier (UDI) |
9341394034303, 9341394034310 |
| Action Type |
Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
The manufacturer of the AeroSCAR Silicone Scar Sheet (ASGS12 & ASGS20) has identified a labelling error on the product’s packaging (box). The affected labels incorrectly state the product as “Single Use Only” and specify a usage duration of “Each use should not exceed 16 hours. Discard after use”.
The product is instead reusable, and for the best effect, it should be replaced every 2 weeks.
Discarding the product prematurely can reduce product effectiveness due to limited duration of use but poses no health risk or injury.
No adverse events or complaints related to product safety, injury, or performance have been reported. |
| Instructions for Customers/Users |
- Retailers should know that consumers can continue to safely use the AeroSCAR Silicone Scar Sheet (ASGS12 & ASGS20) and to increase patient's experience, they should follow the correct usage information provided below:
o The product is reusable.
o For best effect, replace every 2 weeks. This product should be washed using clean warm water, avoiding oily soaps.
- Retailers are requested to inform consumers of this corrected usage information at the point of sale or through their online product listings.
- Aerohealthcare is updating the packaging label for future batches.
- This temporary measure ensures that users receive accurate information and are able to use the product as intended while existing stock remains in the market.
This action has been closed out on 13/07/2026 |
| Action Commencement Date |
21/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 628 881 - Aero Healthcare Customer Service |