Baxter Volara Blue Ventilator Adapter Module recalled for oxygen and lung injury risks in home use
Check Baxter Volara ventilator adapter instructions
Baxter Healthcare has issued an urgent correction for the Blue Ventilator Adapter Module used with the Volara Respiratory Therapy system in home care settings. Patients or caregivers may not be aware of risks including dangerously low oxygen levels or lung injury from improper device use.
- If you use a Baxter Volara system at home, review the updated instructions provided by Baxter immediately
- Contact Baxter Healthcare or your home care provider if you have questions about proper use
- Watch for signs of low oxygen (shortness of breath, confusion, bluish lips) and seek emergency care if they occur
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2026More Baxter Healthcare Corporation recalls
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