Breas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pat…

Recall date

July 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2690-2024

FDA classification

Class I

Brand / firm

Breas Medical, Inc.

Sold / distributed

US Nationwide.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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)