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Breas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati
Recalled September 11, 2024 · FDA recall Z-2690-2024 · Breas Medical
Hazard
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. · FDA Class I
Units
8298
Sold at
US Nationwide.
Description
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.
Product
Vivo 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)
Manufacturer(s)
Breas Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →