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FDAOctober 13, 2023device

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 recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

breas medicalbreas

UPCs

050302671205050732182006093107321820066537

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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