MedSense Medical Disposable Mask (Andatech Pty Ltd)
Product Name
MedSense Medical Disposable Mask
Sponsor
ARTG
340295
Manufacturer
Henan Robestain Medical Products Co Ltd
Type of market action
Product defect alert
Reason
Andatech Pty Ltd has supplied batch number 20200801, which when tested by the TGA, some samples of the device demonstrated inconsistent testing results for fluid resistance at level 1 (80mmHg).
Additional information