| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00671-1 |
| Product Name/Description |
Willieston International Pty Ltd - Disposable Medical Mask - Mask, surgical. single use
Surgical/medical face mask, reprocessed.
ARTG: 336378 - Cancelled by Secretary - 12 January 2021 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/03/2021 |
| 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).
The TGA has cancelled the Device with ARTG number 336378 from the Register on the basis that Willieston International Pty Ltd have been unable to comply with a condition of inclusion for the Device in the ARTG.
The sponsor has not provided appropriate test reports specific for a facemask, that includes comprehensive performance evidence for Bacterial Filtration Efficiency, Splash Resistance and Microbial Cleanliness, under applicable facemask standards, to reflect that the device will perform in the way suitable for its intended purpose. The device packaging is also missing sponsor details, manufacturing/expiry date, batch number/serial no./lot no. and indication for single use only. |
| 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;
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, these masks 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 |
willie.li@ceraflo.com.au |