| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01554-1 |
| Product Name/Description |
Henry Schein Halas - Mask, surgical, single use
Softmed Face Mask - Single Use;
Softmed Surgical Face Mask Medical Disposable;
Softmed Surgical Face Mask Medical Disposable (White); and
Softmed Face Mask Medical Disposable.
Expiry dates: 31-03-2024 and 31-03-2025
All batches of above product.
ARTG: 339400 (Henry Schein Halas - Mask, surgical, single use - cancelled by Sponsor 30/06/2021) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2021 |
| 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).
When tested by the TGA, some samples were found non-compliant when tested for fluid resistance. Due to the inability to distinguish between compliant and non-compliant batches, all batches, supplied under ARTG 339400, may not adequately protect the user from penetration of blood and/ or body fluids and therefore are not fit for medical use and should only be used in non-clinical settings.
Many of the products have labelling deficiencies including: no manufacturer name and/or address, no sponsor name and/or address, no batch numbers and no expiry dates.
Although the products are branded as ‘Softmed’ face masks, this notice does not apply to other face mask products manufactured by Softmed Manufacturing Pty Ltd and supplied under different ARTG entries (and which may be similar in presentation). |
| 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 08/09/2021 |
| Contact Information |
1300 65 88 22 - Henry Schein |