| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00574-1 |
| Product Name/Description |
Med-Con Pty Ltd - Surgical Face Masks
All batches of Med-Con facemasks with a “Med-Con” logo on the mask.
All batches below batch number 43145.
Med-Con Pty Ltd - High Filtration Surgical Face Masks With Ties Level 3.
Hytec - Surgical Face Masks - Earloop - Level 2 Barrier.
Hytec - Surgical Face Masks - Ties - Level 3 Barrier.
ARTG 109872 (Mask, surgical, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/03/2021 |
| 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).
Med-Con Pty Ltd has supplied five batches of Surgical Face Masks which, when tested by the TGA, all samples of the device demonstrated inconsistent testing results for fluid resistance at the location of the logo only. In some cases, these devices did not pass at level 1 at the location of the logo. Testing confirms the devices offer level 2 or 3 fluid resistance at the main body of the mask in line with the level of fluid resistance claimed.
There are also some labelling deficiencies on the packaging including unidentifiable manufacturer name and/or address, unidentifiable sponsor name and/or address, no indication of batch/lot number, no expiry or indication of expiry, no storage conditions and no precautions. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
The TGA does not require the face masks to be physically recalled from the market.
Caution should be taken with Med-Con single use surgical masks with a Med-Con logo on the corner of the mask. Additional protection via a face shield/visor should be considered when using Med-Con masks with logos and if they are being used in high risk clinical or patient/caregiving scenarios where a level 2 or 3 fluid resistance barrier is required. Adhering fluid resistant tape to the inside of the mask over the logo area may also reduce to risk to users.
As individual boxes of Med-Con facemasks may include masks with and without the Med-Con logo, each mask should be checked individually and used in an appropriate setting.
Med-Con Surgical Face Masks without a Med-Con logo on the mask and all masks manufactured after 6/12/20 (Batch 43145 onwards) CAN be safely used in settings where a level 2 or 3 fluid resistance barrier is required.
This action has been reviewed and is considered complete. |
| Contact Information |
(03) 5822 6600 - Med-Con Customer Service |