| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00363-1 |
| Product Name/Description |
Ripe KN95 Nanofiber filtration Anti-Particulate Anti-virus Mask
Batch number: 2020-03-30
ARTG 333938 - Arya Mobility Pty Ltd - Mask, surgical, single use - Cancelled by Secretary at the Sponsors request 17/05/2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2022 |
| 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).
Arya Mobility Pty Ltd has supplied batch number 2020-03-30 of respirators which have shown inconsistent testing results, specifically for Particulate Filtration Efficiency (PFE), which measures the efficiency of the respirator to filter fine particles from inspired air. Respirators which perform below the claimed level of PFE will not afford their wearers the expected level of protection when used in an environment where respiratory protection is required.
Samples provided to the TGA also showed that the nose piece was not adequately affixed, and the nose piece does not have memory to provide an adequate seal.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and return goods to the Sponsor.
This action has been closed out on 02/02/2024 |
| Contact Information |
0402 213 044 - Vijay Pandya |