| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01528-1 |
| Product Name/Description |
OAPL Protective Face Mask with Earloops KN95 Mask 4PLY EAR LOOP
Batch number: 202004-9
ARTG 333822 - Cancelled as of 12/05/2022 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2022 |
| 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).
Orthotic & Prosthetic Centre (OPC) Pty Ltd has supplied batch 202004-9 of OAPL KN95 masks which, when tested by the TGA, demonstrated inconsistent testing results for Particulate Filtration Efficiency (PFE). 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. OPC will organise the return and replacement of impacted stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
03 9681 9666 - Product Manager |