| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00229-1 |
| Product Name/Description |
e-PTFE Micro-filtration Membrane Mask
Batch number: 202004
Expiry date: 22-April-2022
ARTG 333846 - BMS - Surgical respirator - Cancelled by Secretary at Sponsors request 30 July 2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2022 |
| 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).
BMS has supplied 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.
The TGA has cancelled the Devices with ARTG number 333846 from the Register at the Sponsors request.
Following cancellation of this ARTG entry, the sponsor has not provided any relevant supply information, including a list of their customers to whom these face masks may have been distributed. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
The TGA does not require the face masks to be physically recalled (or otherwise removed) from the market.
For users who are operating in environments where a P2 respirator or equivalent respirator (e.g. N95 or >95%PFE) is recommended or required, including areas when protection is required to minimise exposure to bushfire smoke/ poor air quality and associated health effects, an alternative product that offers the expected level of respiratory protection should be used.
Customers should consider:
- quarantining the product
- Ceasing use of the product in areas where 95% particulate filtration efficiency is required.
It is at the user’s discretion to determine if these products should or could be re-deployed depending on where they are currently being used.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
|