| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02341-1 |
| Product Name/Description |
Gemini KN95 Protective Medical Masks
Batch Number: CY-20200519-1
Expiry Date: 19/05/2022
ARTG 335054 - Cancelled by Secretary under Sponsors request on 26/08/2021.
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/01/2022 |
| 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).
Mediquip Pty Ltd has supplied batch CY-20200519-1 of Surgical Respirators which, when tested by the TGA, samples of the device demonstrated inconsistent testing results for fluid resistance and Particulate Filtration Efficiency (PFE). Batch CY-20200519-1 may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals.
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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 246 349 - Wendy Chown |