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FDAJuly 25, 2024device

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)

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

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

breas medicalbreas

UPCs

07321822300004

Recall history

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

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