| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-01167-1 |
| Product Name/Description |
Softmed surgical face masks
ARTG 333133 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2020 |
| Responsible Entity |
|
| Reason/Issue |
TGA testing and post-market review indicate an absence of batch numbers and inconsistent testing results requiring further investigation/review. Certain batches tested for fluid resistance demonstrated inconsistencies:
1. A small number of batches have been supplied under ARTG 333133 where the majority of which do not have batch numbers to enable easy identification
2. Supply of various batches have been direct to customers or via a number of third party distributors
3. The claim of “Level 3” fluid resistance when tested by TGA Laboratories indicate some batches failed at Level 3, but passed at Level 2. Others failed at Level 3 and Level 2, but passed at Level 1
Due to the variability in fluid resistance performance, users should take a precautionary approach where masks supplied under ARTG 333133 are being used in a medical / healthcare/ surgical / aged care setting where the wearer could be exposed to splashes of potentially contaminated liquids or droplets. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Masks are not removed from the market. Batches supplied under ARTG 333133, consideration should be given to the setting in which these are used, as the masks have variability in fluid resistance. Due to the inability to trace certain batch numbers, users should take a precautionary approach if masks without batch numbers are being used in a medical / healthcare/ surgical / aged care setting to reliably protect the wearer against splashes of potentially contaminated liquids or droplets. Users should consider:
1. quarantining the product;
2. using them in another setting; and/or
3. 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.
•If you have supplied potentially affected goods to another facility or organisation, please let that facility know of the PDA by providing a copy of this letter. |
| Contact Information |
S Tsimidanov, sergio@softmed.com.au |