Baxter Healthcare recalled 19 Blue Ventilator Adapter Modules used with the Volara Respiratory Therapy system in Florida after an urgent correction flagged potential oxygen desaturation and barotrauma risks in home care. The correction provides home caregiver instructions for use. Patients and healthcare providers should stop using this device immediately and contact Baxter or a healthcare provide
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
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The Blue Ventilator Adapter Module is an accessory to the Baxter Volara Respiratory Therapy system used in home care to support ventilation therapy.
The recall centers on the risk that users may not recognize a drop in oxygen levels or potential lung injury from overexpansion when using the Volara system at home.
This recall is not part of a broader industry pattern.
The recall affects 19 units in Florida and requires immediate stop-use actions to reduce serious harm risk for home care patients.
Device label should display Product Code M07937 and UDI 00887761984622
Baxter will provide recall remediation instructions; no refunds information is provided in the notice
Keep the recall notice, device labels, and UDI. Document dates of purchase and any communications with Baxter or providers. Photographs of the device and label are helpful.
Blue Ventilator Adapter Module; Product Code M07937; Accessory to Baxter Volara Respiratory Therapy system; Quantity: 19 units; Distribution: Florida; Sold at: Unknown; Date sold: Unknown; Price: Unknown
No injuries or incidents have been reported.
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