| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00555-1 |
| Product Name/Description |
Surgical Face Mask Level 2
Batch numbers: 2004031, 2004051 and 2004011
ARTG 335086 - Cancelled as of 18/11/2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2022 |
| 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).
Multigate Medical Products Pty Ltd has supplied 3 batches (2004031, 2004051 and 2004011) of Surgical Face Mask Level 2 which have been cancelled from the ARTG. The TGA has not received appropriate information which would allow it to determine whether these devices are of satisfactory quality, safety, performance, or presentation.
Following TGA lab testing, batch 2004031 failed level 2 fluid resistance (120mmHg).
The three batches of Multigate’s 54-420 Surgical Face Mask Level 2 are not fit for medical use and should only be used in non-clinical settings as there may be issues with the manufacturers quality systems |
| 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.
These masks should not be used in clinical or patient/caregiving scenario including hospital wards, operating theatres, general practice, nursing homes or during in-home care / support services where a level 2 fluid resistance is required.
At the user’s discretion or where the use of face masks is mandated under the provisions of a state or territory public health order, Surgical Face Mask Level 2 should only be used in non-clinical environments such as domestic households, retail shops, food and beverage outlets, public transport, outdoor settings, etc.
Customers should consider:
• quarantining the product;
• using them in another setting; and/or
• if they do not have alternatives, ensuring that a face shield is used in high risk settings.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8718 2888 - Multigate Medical Products |