FDA-Device2024-10-30Class I
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
Baxter Healthcare Corporation
Hazard
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.
Sold states
US nationwide distribution.
Affected count
10,957 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0046-2025Don't want to check this manually?
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