| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00559-1 |
| Product Name/Description |
Single use, surgical, mask
ARTG 332604 cancelled as at 8 Feb 2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/06/2023 |
| 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).
The TGA has cancelled the Devices with ARTG number(s) 332604 from the Register on the basis that Aidacare Pty Ltd failed to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.
Following cancellation, samples were provided for batches 2020070705, 20-60026YH and MAS100100. All of these batches failed visual inspection due to labelling insufficiencies, and batch 20-60026YH failed fluid resistance test at level 2.
Following cancellation, the Sponsor confirmed some masks of batch MAS100100 were supplied to healthcare settings. Majority of the stock would have now expired, however the expiry dates were not listed on the packaging so would be difficult for the end user to ascertain. |
| 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.
This action has been closed out on 22/01/2024 |
| Contact Information |
0434 566 773 - David Owen, Chief Product Officer |