Baxter Volara ventilator adapter recalled for possible oxygen drop
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.
From the FDA notice · Read the official notice ↗ · All Baxter recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Sold in
- Florida
- Made for
- All ages
Details
- Units affected
- 19 units
- Illnesses reported
- None reported
- Manufactured in
- 1 Baxter Pkwy, Deerfield, IL, United States
- Classification
- Class I
- Recall number
- Z-1637-2026
In the FDA's words
- Description
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. 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. UDI/DI number 00887761984622 Distribution: Florida Affected quantity: 19 units
- 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.
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