| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01032-1 |
| Product Name/Description |
Runsmart Corporate Pty Ltd - ARTG: 333609
Public N95 Respirator
ARTG: 333609 - Cancelled by the Secretary - as of 03 February 2021. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2021 |
| 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 Devices with ARTG number(s) 333609 from the Register on the basis that Runsmart Corporate Pty Ltd requested the cancellation in accordance with section 41GL(d) of the Theraputic Goods Act 1989.
Following cancellation of these ARTG entries, the sponsors have also not provided any relevant supply information, including a list of their customers to whom these face masks may have been distributed.
Following cancellation of these ARTG entries, the sponsors have also not provided any relevant supply information, including a list of their customers to whom these face masks may have been distributed. |
| 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.
For users who are operating in environments where a P2 respirator or equivalent respirator (e.g. N95 or >95%PFE) is recommended or required, including areas when protection is required to minimise exposure to bushfire smoke/ poor air quality and associated health effects, an alternative product that offers the expected level of respiratory protection should be used.
Customers should consider:
- quarantining the product
- Ceasing use of the product in areas where 95% particulate filtration efficiency is required.
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 closed out on 02/09/2021 |
| Contact Information |
navjot.cheema@runsmart.com.au |