Medtronic formerly Covidien recalls Puritan Bennett 980 Series Ventilator

Recall date

March 25, 2022

Source

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

Recall number

Z-0966-2022

FDA classification

Class I

Brand / firm

Medtronic formerly Covidien

Sold / distributed

US Nationwide - Worldwide .Distribution

Why it was recalled

The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

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

Puritan Bennett 980 Series Ventilator