January 5, 2022

FDA: Class I recall of Puritan Bennett 980 Series Ventilator

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious.

The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended.

There have been six complaints and one death associated with this device issue.

Distribution dates were February 23, 2017, to April 4, 2020.

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