| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02406-1 |
| Product Name/Description |
Makrite 9500-N95 Particulate Respirators
Surgical/medical respirator, single-use
Batch number: 050520
Expiry date: 04/2023
ARTG: 337553 - Cancelled by Secretary as of 03/12/2021 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/12/2021 |
| 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).
Orien Dental Supplies has supplied respirators under batch number 050520, 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.
The TGA has cancelled the Device with ARTG number 337553 from the Register at the sponsors request, as of 03 December 2021. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and return goods to the Sponsor or destroy goods on site.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 880 711 - Orien Dental Supplies |