FDA recall Z-1141-2023

Baxter Healthcare Corporation · Class I · device

Product

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2023-01-25
Report date: 2023-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1141-2023