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Breas Medical, Inc. recalls with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator de
Recalled December 6, 2023 · FDA recall Z-0405-2024 · Breas Medical
Hazard
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation · FDA Class II
Units
215 units
Sold at
Nationwide Foreign: Canada
Description
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
Product
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
Manufacturer(s)
Breas Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →