Medical device recalls High risk

Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Recall date
December 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0884-2025
FDA classification
Class I
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US, Nationwide Distribution

Why it was recalled

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

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

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

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