| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00296-1 |
| Product Name/Description |
Public respirator, single use
ARTG 337174 cancelled as at 9/3/22 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2023 |
| Responsible Entity |
|
| Reason/Issue |
The Therapeutic Goods Administration (TGA) has undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).
The TGA has cancelled the Devices with ARTG number(s) 337174 from the Register on the basis that Aspen Medical Pty Ltd failed to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.
The TGA since received some samples, and the samples of the devices has failed the test for Particulate Filtration Efficiency. Therefore, these respirators may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to:
• Immediately quarantine all affected stock on hand and discontinue use.
• Please contact Aspen Medical immediately and fill in the customer acknowledgement form with quantity of remaining stock. Aspen Medical will work with the customer regarding any impacted remaining stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
Ed Smeaton, General Manager - 0498 313499 |