| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02021-1 |
| Product Name/Description |
P2 Healthcare Particulate Respirators
Batch Number: AMM019; AMM017
Expiry Date: 1/02/2023; 3/03/2024
ARTG 337267 (Public respirator, single-use) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2021 |
| 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).
Aspen Medical Manufacturing 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 any impacted product to Aspen Medical Manufacturing.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 6203 9500 - Aspen Medical Customer Service |