FDA-Device2023-03-08Class I

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

Baxter Healthcare Corporation
Hazard

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Sold states
Nationwide
Affected count
4279 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2023

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