| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00410-1 |
| Product Name/Description |
OWear Mask with Earloop Fluid Protection IIR-120 mmHg
Product code: SCM-5500
Batch number: 043020
Expiry date: 1/04/2025
ARTG 333072 – Sentry Medical Pty Ltd - Mask, surgical, single use - Cancelled by Secretary at Sponsors request 9/02/2022 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2022 |
| 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).
Sentry Medical Pty Ltd has supplied batch number 043020 of OWear Mask with Earloop Fluid Protection IIR-120 mmHg which, when tested by the TGA, samples of the device demonstrated inconsistent testing results for fluid resistance level 2 (120mmHg). |
| 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 or above 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, OWear Procedure Mask - Earloop OMK001 Level 2 may also 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 31/03/2022
This action has been closed out on 31/03/2022 |
| Contact Information |
1300 995 999 - Sentry Medical |