Brand
Breas Medical, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Breas Medical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-09-11FDA-DeviceClass IVivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
- 2023-12-06FDA-DeviceClass IIwith 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.
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
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