FDAFebruary 18, 2026device
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
00887761984622
Recall history
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