| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00415-1 |
| Product Name/Description |
Beare Medical Face Mask for Single Use - Level 2 Barrier - BMD 2
Batch number: 26042020 and JP20200606
Expiry date: 30/04/2022 and 31/06/2022
ARTG 334584 and 337382
(AUSTRALIAN BUSINESS MOBILES (NSW) PTY LTD - Mask, surgical, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/03/2022 |
| 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).
Australian Business Mobiles Pty Ltd has supplied batches of Beare Medical Face Mask for single use which, when tested by the TGA, demonstrated inconsistent testing results for fluid resistance at level 2 (120mmHg). |
| 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 a level 2 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, Beare Medical Face Mask may also 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 |
0459 900 655 - Michael Goldberg |