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Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation

Nevada Medicaid·NV · Pulmonology, Critical Care, Anesthesiology·Provider Announcement
Effective date
Sep 20, 2024
We identified it
Jun 21, 2026
Days to comply

Summary

Baxter Healthcare Corporation has issued a Class I recall (most serious type) for certain Volara System lung therapy components due to disconnection risks that may prevent proper ventilation and could cause serious injury or death. Healthcare providers must immediately stop using these recalled devices and contact Baxter customer service.

Action Required

Action needed
Immediately: Clinical staff must identify and remove all recalled Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies from inventory and patient use. Contact Baxter Advanced Respiratory customer service at 800-426-4224 (option 2 for Acute Care or option 3 for Home Care) for recall instructions. Review FDA website for complete recall details. Document any patients who may have been affected by these devices.