Ventilator Correction: Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm

Baxter Healthcare is updating use instructions for the Life2000 ventilator after identifying that this ventilator may fail to issue a Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not connected to the ventilator and turned on before starting therapy. The firm is currently working on a software update to address this issue and will contact all impacted customers to update their devices once the update is available.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Questions?

Customers in the U.S. with questions about this recall should contact Advanced Respiratory, Inc. Acute Care customer service at the following phone numbers:

• Health care providers/customers: 800-426-4224, option 2.

• Home care/patients: Home Care Customer Service 800-426-4224, option 3.