| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01986-1 |
| Product Name/Description |
BYD N95 Healthcare Particulate Respirator
Batch Number 9200430
ARTG 332300 (BYD AUSTRALIA PTY LTD - Public N95 respirator) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/09/2021 |
| 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).
BYD Australia Pty Ltd has supplied batch No: 9200430 of N95 Healthcare Particulate Respirators which, when tested by the TGA, all samples of the device demonstrated inconsistent testing results for fluid resistance and particle filtration efficiency. Batch Number 9200430 of BYD N95 respirators may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals.
No other batch of BYD N95 Healthcare Particulate Respirators are impacted by this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine any unused goods on site and contact BYD for return and replacement.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8387 1753 - BYD Australia |