Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3…

Recall date

September 12, 2024

Source

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

Recall number

Z-0046-2025

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US nationwide distribution.

Why it was recalled

The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

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 Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP