| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00599-1 |
| Product Name/Description |
Aster Home Nursing Services Facemasks
ARTG 332939 (Mask, surgical, single use) - Cancelled by Sponsor 25/06/2020
ARTG 334004 (Mask, surgical, single use) - Cancelled by Sponsor 25/06/2020 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/12/2020 |
| 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).
Aster Home Nursing Services has supplied batches of single use surgical masks without evidence to support compliance with the essential principles or device conformity assessment procedures.
Users are advised that these particular masks may not fully perform as intended, when dealing with potentially infected patients. These masks should therefore not be used in that sort of clinical or patient/caregiving scenario including hospital wards, operating theatres, general practice, nursing homes or during in-home care / support services. |
| 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 reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
07 5611 5060 - Aster Home Nursing Services |