FDA-Device2023-12-06Class II
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.
Breas Medical, Inc.
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
Sold states
Nationwide Foreign: Canada
Affected count
215 units
Manufactured in
16 Esquire Rd, North Billerica, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2024Don't want to check this manually?
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