| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00369-1 |
| Product Name/Description |
Proshield Duckbill Fluid Resistant, Proshield Resistant, Proshield Clearview, Proshield Elite Visor Mask, Proshield Elite Antifog Mask, Proshield Elite Pleated Mask and Proshield Super Resistant Antifog Mask
Product codes: 72509-00,72509-04,72509-11,72509-19, 72509-20, 72509-21 and 72509-23
Batch numbers: 26Oct17, 39642 1, 18Sep20, 10Aug17, 29Jun20, 06Oct20 and 14Oct20
ARTG 305431
(BSN Medical (Aust) Pty Ltd - Mask) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/03/2022 |
| 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).
BSN Medical Pty Ltd has supplied batches of Proshield Surgical masks which, when tested by the TGA, samples of the device demonstrated inconsistent testing results for the level of fluid resistance claimed:
- Duckbill Fluid Resistant, Batch 26Oct17 – Non-compliant at level 2 fluid resistance at the seam.
- Resistant, batch 39642 1 – Non-compliant at level 2 fluid resistance at the logo.
- Clearview, batch 18Sep20 – Non-compliant at level 3 fluid resistance.
- Elite Visor Mask, batch 10Aug17 – Non-compliant at level 3 fluid resistance at the embossed line.
- Elite Antifog Mask, batch 29Jun20 – Non-compliant at level 2 fluid resistance.
- Elite Pleated Mask, batch 06Oct20 – Non-complaint at level 3 fluid resistance.
- Super Resistant Antifog Mask, batch 14Oct20 – Non-compliant at level 3 fluid resistance.
|
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Proshield surgical 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 3 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 Proshield surgical masks 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.
It is at the user’s discretion to determine if these products should or could be re-deployed depending on where they are currently being used.
This action has been reviewed and closed out as per the URPTG. |
| Contact Information |
1300 276 633 - Essity (BSN Medical) |