Primasoft Surgical Mask, Tie, Soft, White, Pg4-2333; Primagard Procedure Mask, Ear Loops, Blue, Pm4-306; Primed Surgical Mask, Tie, Anti-Fog, Blue, Pm4-311 And Primed Pediatric Mask, Earloop, Dinosaur Pattern, Pg4-1680. (Sentry Medical Pty Ltd)
Product Name
Primasoft Surgical Mask, Tie, Soft, White, Pg4-2333; Primagard Procedure Mask, Ear Loops, Blue, Pm4-306; Primed Surgical Mask, Tie, Anti-Fog, Blue, Pm4-311 And Primed Pediatric Mask, Earloop, Dinosaur Pattern, Pg4-1680.
Sponsor
Manufacturer
priMED Medical Products Inc
Type of market action
Product defect alert
Reason
Sentry Medical has supplied multiple models/batches of facemasks to the TGA, which when tested, samples of the device(s) demonstrated inconsistent testing results for fluid resistance. - PG4-2333 (batch 0419HLP20) demonstrated fluid resistant deficiencies at 160mmHg (level 3).- PM4-306 (batch 0426CLP20) demonstrated fluid resistant deficiencies at 120mmHg (level 2). - PM4-311 (batch 0523DLP21) demonstrated fluid resistant deficiencies at 120mmHg (level 2).- PG4-1680 ( batch 0414HLP20) demonstrated fluid resistant deficiencies at 80mmHg (level 1).
Additional information