| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00074-1 |
| Product Name/Description |
PM4-306 - PRIMAGARD PROCEDURE MASK, EAR LOOPS, BLUE
Batch numbers: 0423LLP20, 0410LLP21, 0417LLP21, 0429KLP21, 0608ALP21
PM4-311 - PRIMED SURGICAL MASK, TIE, ANTI-FOG, BLUE
Batch number: 0526DLP21
ARTG 212197
(Sentry Medical Pty Ltd - Mask, surgical, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2023 |
| 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 has supplied multiple batches of masks which when tested by the TGA failed fluid resistance testing at level 2 (120mmHg).
This is an expansion to RC-2022-RN-00217-1. |
| 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 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, these 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:
• 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 reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 995 999 - Sentry Medical |