| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00312-1 |
| Product Name/Description |
Arya Mobility Pty Ltd
Mask, surgical, single use
Batch: 20200318
ARTG: 336156 - Arya Mobility Pty Ltd - Mask, surgical, single use Cancelled by sponsor 30/8/2022 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2023 |
| 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).
Arya Mobility has supplied a batch ( 20200318) of Mask, surgical, single use which, when tested by the TGA, demonstrated inconsistent testing results for fluid resistance. |
| 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.
These masks should not be used in clinical or patient/caregiving scenario including hospital wards, operating theatres, general practice, nursing homes or during in-home care / support services where fluid resistance is required.
At the user’s discretion or where the use of face masks is mandated under the provisions of a state or territory public health order, these masks should only be used in non-clinical environments such as domestic households, retail shops, food and beverage outlets, public transport, outdoor settings, etc.
Customers should consider:
• quarantining the product;
• using them in another setting; and/or
• if they do not have alternatives, ensuring that a face shield is used in high risk settings. |
| Contact Information |
vijaycpandya@gmail.com |