| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00768-1 |
| Product Name/Description |
BYD Australia Pty Ltd - BYD Care Single use Surgical Mask
All batches of BYD Care Single Use Surgical Masks with a “BYD” logo on the corner of the mask.
ARTG 332299 (Mask, surgical, single use) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/04/2021 |
| 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 three batches of Surgical Face Masks which, when tested by the TGA, all samples of the device demonstrated inconsistent testing results for fluid resistance at the location of the logo only. Testing confirms the devices offer level 2 fluid resistance at the main body of the mask in line with the level of fluid resistance claimed.
There are also some labelling deficiencies on the packaging including no indication of batch/lot number/serial number(s) and no date of manufacture.
The failed fluid resistance testing affects the BYD single use surgical face masks that are included under the ARTG 332299. This notice does not relate to the BYD respirators. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
The TGA does not require the face masks to be physically recalled (or otherwise removed) from the market.
Caution should be taken with BYD Australia Pty Ltd single use surgical masks with a “BYD” logo on the corner of the mask. Additional protection via a face shield or visor should be considered if you use BYD Australia masks with logos and if they are being used in high risk clinical or patient/caregiving scenarios where a level 2 or 3 fluid resistance barrier is required.
It is at the user’s discretion to determine if these products should or could be re-deployed depending on where they are currently being used.
This action has been closed out on 06/08/2021 |
| Contact Information |
02 8387 1753- BYD Australia Pty Ltd |