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Type of Product Medical Device
TGA Recall Reference RC-2021-RN-00856-1
Product Name/Description Amcor Flexibles (Australia) - ARTG: 334438

Airway Protection Face Mask

ARTG: 334438 - Cancelled by Secretary - 30 September 2020
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/04/2021
Responsible Entity Amcor Flexibles (Australia)
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 Devices with ARTG number(s) 334438 from the Register on the basis that Amcor Flexibles (Australia) failed to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.

The TGA has not have received important information to determine whether these facemasks comply with the medical device essential principles or whether they are of satisfactory safety, performance, presentation or quality.

Following cancellation of these ARTG entries, the sponsors have also 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.

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.
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