Baxter Healthcare Corporation is recalling 19 units of the Volara system single-patient use circuit, specifically the Blue Ventilator Adapter Module. This recall was initiated because patients or caregivers using the device at home may be unaware of a potential decrease in oxygen levels (oxygen desaturation) or the risk of lung tissue injury (barotrauma) caused by overexpansion. This medical device correction provides essential updated instructions for home caregivers to ensure the device is used safely.
The device may cause a sudden decrease in oxygen levels or lung overexpansion, which can lead to serious respiratory injury or barotrauma, especially when caregivers are not properly alerted to these changes in the home care environment.
Accessory to Baxter Volara Respiratory Therapy system.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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