| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00189-1 |
| Product Name/Description |
St John Respirator Mask
Batch number: 20200501S0002
Expiry date: 10 May 2023
ARTG 335586 - St John Ambulance Australia Inc - Surgical/medical respirator, single-use - Cancelled by Secretary at Sponsors request 16/10/21 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/01/2022 |
| 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).
St John Ambulance Australia has supplied batch number 20200501S0002 of St John Respirator Masks which, when tested by the TGA, some samples of the device demonstrated inconsistent testing results for Particulate Filtration Efficiency (PFE).
Batch number 20200501S0002 of St John Respirator Masks may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals.
The TGA has cancelled the Device with ARTG number 335586 from the Register at the Sponsors request, as of 16/10/2021. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and return goods to the Sponsor, who will replace affected stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9725 2747 - Dilhan De Silva, St John Ambulance Australia |