| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00586-1 |
| Product Name/Description |
Promed Level 1 surgical face masks with ties
Promed Level 1 surgical face masks with Ear loops
Product reference code: PMD 4501 and PMD 4001
Batch numbers: 16-Sep-20 and 25-Aug-20
ARTG 126887
(Thermo Fisher Scientific Australia Pty Ltd- Mask, surgical, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/05/2022 |
| 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).
Thermofisher has supplied two models (one batch each) of Level 1 surgical face masks manufactured by Thai Hospital Products Co. Ltd., Thailand, under ARTG 126887 . Both models have failed to fluid resistance testing at level 1 (80mmHg). This means users of these level 1 surgical face masks may not be adequately protected against contamination with blood and other body fluids in a clinical environment.
Level 2 and level 3 masks (PMD1595 Promed fluid resistant facemask with loops and PMD1995 Surgical Face Mask with Ties respectively) tested by the TGA successfully passed the fluid resistance test. |
| 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.
Promed Level 1 surgical face masks should therefore 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 any 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, Promed Level 1 surgical face 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:
o quarantining the product;
o using them in non-medical or clinicalsettings.
o 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 |
1300 735 292 - Customer Care Team |