Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2022-RN-00278-1
Product Name/Description Halyard Surgical Mask

Product code 6000
Batch number TH 02161644

Halyard Procedure Mask

Product code 6001
Batch number TH 00321547

ARTG 272589 - Cancelled as of 13/11/2021
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 17/02/2022
Responsible Entity O&M Halyard Australia Pty Ltd
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).

O&M Halyard Australia Pty Ltd has supplied two batches (TH 02161644 and TH 00321547) of Surgical and Procedural Face Masks which, when tested by the TGA, both batches of the device demonstrated inconsistent testing results for blood resistance at 80mmHg (level 1).

ARTG number 272589 has been cancelled at the sponsors request.
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.

Halyard Surgical and Procedural 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 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, Halyard Surgical and Procedural 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 based on the advice that O&M Halyard Australia has received from the TGA, if they do not have alternatives, ensuring that a face shield is used in high risk settings.

This action has been closed out on 18/03/2022
Contact Information 0448 481 200 - Laleetha Devi