| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02020-1 |
| Product Name/Description |
Evolve IPKIS P2 Particulate Respirators and Evolve IPKIS P2 Surgical Respirators.
All batches manufactured prior to 07/10/2021.
ARTGs:
334314 (Public respirator, single-use)
344488 (Surgical/medical respirator, single-use) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/10/2021 |
| 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).
Evolve Group Pty Ltd has supplied batches 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and return impacted product to the sponsor. |
| Contact Information |
admin@evolvegrp.com |