| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00831-1 |
| Product Name/Description |
Big Start Pty Ltd- Disposable Medical Face Mask
Batch number 2020/4/21
Manufacturing date: 21/04/2020
Expiry date: 21/04/2022
ARTG 340635 (Big Start Pty Ltd- Mask, surgical, single use- Cancelled by Secretary 30 March 2021) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/05/2021 |
| 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).
The TGA has cancelled the Device with ARTG number 340635 from the Register on the basis that Big Start Pty Ltd failed to provide all the information/documents that the subsection 41JA(1) notices required within a further 10 working days from the day specified in that notice.
The TGA has not 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.
This action has been closed out on 07/07/2021 |
| Contact Information |
0412 420 806 - Big Start Pty Ltd |