| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00328-1 |
| Product Name/Description |
Biovent Consulting - LONGXIN and ZERUI Facemasks - Mask, surgical, single use
ARTG: 334953 (Mask, surgical, single use - Cancelled by Secretary 12 October 2020)
ARTG: 333081 (Mask, surgical, single use - Cancelled by Secretary 12 October 2020) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2021 |
| 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).
Under section 41JA of the Therapeutic Goods Act 1989 (the Act), the Secretary or their delegate may require information or documents, relating to devices of that kind that are relevant to whether the device complies with the Act and the Therapeutic Goods (Medical Devices) Regulations 2002.
The TGA has cancelled the Devices with ARTG numbers 333081 & 334953 from the Register on the basis that Biovent Consulting 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 has not have received important information to determine whether these facemasks comply with the medical device essential principles or whether they are of satisfactory safety, performance, presentation or quality. |
| 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;
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 |
02 6762 2321 - Biovent Consulting |