| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00096-1 |
| Product Name/Description |
Health One Surgical Face Mask with Eye Shield Anti-fog, Anti-splash
Batch: S2020-29501, S2020-36501, S2020-36502, S2020-36503
Expiry: 14/08/2025, 30/10/2025, 12/11/2025, 24/11/2025
ARTG 340761 Health One Pty Ltd - Mask, surgical, single use - Cancelled by Secretary 20 September 2022 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2023 |
| 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).
Health One Pty Ltd has supplied a batch of surgical face mask with eye shield, which when tested by the TGA failed fluid resistance testing at level 3 (160mmHg).
The device has been cancelled from the ARTG on the basis that Health One Pty Ltd have failed to comply with one or more conditions to which the inclusion of the Devices in the ARTG is subject (paragraph 41GN(1)(b) of the Act). |
| 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 there is a risk of blood or body fluid splash or spray.
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 1/3/2024. |
| Contact Information |
glen.thomson@healthone.com.au |