| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01173-1 |
| Product Name/Description |
D-Touch Disposable Medical Facemasks
All D-Touch Disposable Medical Facemasks manufactured prior to 06-May-2022
D-Touch Disposable Medical Facemask with Elastic Bands
Batch / Expiry:
202003 / Mar-23
202004 / Apr-23
D-Touch Disposable Medical Facemask with Tie-on
Batch / Expiry:
202010 / Oct-23
ARTGs 331305 and 341097 (SWISS MADE BRANDS PTY LTD - Mask, surgical, single use) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2022 |
| 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).
Swiss Made Brands has supplied batches of D-Touch Disposable Medical Facemasks which when tested by TGA Laboratories, failed level 2 and 3 fluid resistance on the main body.
The manufacturer has since conducted corrective and preventative actions to improve the quality of the masks. All batches of D-Touch Disposable Medical Facemasks manufactured after 6 May 2022 are not impacted by the fluid resistance issue.
Inappropriate use of D-Touch Disposable Medical Facemasks, manufactured prior to 6 May 2022 may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals in settings where a level 2 or 3 fluid resistance barrier is required. |
| 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
D-Touch Disposable Medical Facemasks, manufactured prior to 6 May 2022 should not be used in settings such as clinical scenarios where a level 2 or 3 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, D-Touch Disposable Medical Facemasks, manufactured prior to 6 May 2022 may also be used in non-clinical environments
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.
It is at the user’s discretion to determine if these products should or could be re-deployed depending on where they are currently being used
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
(03) 9338 3519 - Paul Neil (Swiss Made Brands Pty Ltd) |