| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01688-1 |
| Product Name/Description |
Laleen Health International Pty Ltd - ARTG: 334845 and 333921
Public Respirator, Single Use
ARTG: 334845 and 333921 - Cancelled by Secretary - as of: 16 June 2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/09/2021 |
| 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) 334845 and 333921 from the Register on the basis that Laleen Health International Pty Ltd failed to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.
The TGA has not have received important information to determine whether these facemasks comply with the medical device essential principles or whether they are of satisfactory safety, performance, presentation or quality.
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 29/09/2021 |
| Contact Information |
Julie Lee - julialee3003@gmail.com |