| TGA Action ID |
RC-2025-RN-00432-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Smartloop Green
Lot Number: A102-25
Expiry date (internal label): 01-01-2023 |
| ARTG Number |
319124 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
During an internal investigation, DemeTECH the manufacturer of Smartloop device has identified a labelling error on the internal label of the Smartloop Green, Lot A102-25.
The incorrect expiry date of 01-01-2023 was inadvertently printed on the internal label due to labelling process deviation.
The outer packaging and all other labelling components are correct and reflect the approved expiry date of 01-01-2030.
There is no risk to health associated with discrepancy in labelling. This incident is not related to any serious injury and the products is not likely to cause adverse health consequences. The labelling error could result in confusion for clinicians reviewing medical records or staff performing inventory management. |
| Instructions for Customers/Users |
Customers are to return affected stock including consigned stock. Replacement stock will be provided.
This action has been finalised on 7/7/2025. |
| Action Commencement Date |
6/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 168 - regulatory@ebosmedtech.com - Life Healthcare |