| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00281-1 |
| Product Name/Description |
Veisha KN95 Mask
Public respirator, single-use
Batch number: 20040716
Expiry date: 06/04/2022
ARTG 342673 - Cancelled as of 07/06/2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/02/2022 |
| 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).
Optimed Technologies has supplied Veisha KN95 Mask which, when tested by the TGA, demonstrated inconsistent testing results for fluid resistance and Particulate Filtration Efficiency (PFE).
The TGA has cancelled the device with ARTG 342673 under the request of the Sponsor in accordance with section 41GL(d) of the Therapeutic Goods Act 1989 (the Act). |
| Recall Action |
Recall |
| Recall Action Instructions |
Optimed Technologies has advised the customer to immediately quarantine all affected stock and discontinue use. Optimed Technologies will organise the return and replacement of impacted stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9052 7888 - Damian Chown |