| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01069-1 |
| Product Name/Description |
Omni-Tel Pty Ltd - Quovo Mask - Mask, surgical, single use
Batch number: OT180401A
Expiry date: 03/2021
ARTG: 308620 (Mask, surgical, single use - cancelled by Secretary on 05/01/2021)
|
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/05/2021 |
| 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).
The TGA has cancelled the Device with ARTG number 308620 from the Register at the sponsors request, Omni-Tel Pty Ltd.
Following cancellation of this ARTG entry, the sponsor failed to provide information to support claims made on safety, performance, presentation or quality of the affected Device. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are advised to immediately stop use of the product as it expired in March 2021.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
08 7001 6968 - Omni Tel Pty Ltd |