| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01193-1 |
| Product Name/Description |
Kogan Australia Pty Ltd - 3 Ply Personal Protective Disposable Face Mask (50 Pack)
Batch number: 2020041005 and 2020041004
Expiry date: 09/04/2025
ARTG: 334243 (Mask, surgical, single use - Cancelled by Secretary 05/03/2021) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/05/2021 |
| 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 Devices with ARTG number 334243 from the Register upon the sponsors request.
Kogan Australia Pty Ltd has supplied two batches (2020041005 and 2020041004) of Surgical Face Masks which, when tested by the TGA, samples of batch 2020041005 demonstrated inconsistent testing results for blood resistance.
Both batches also exhibit some labelling deficiencies on the packaging including no sponsor details. |
| 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 closed out on 01/07/2021 |
| Contact Information |
supervisor@kogan.com.au - Customer Service Team |