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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
Baxter is recalling certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the handset plug within these components may disconnect from the nebulizer port on the blue ventilator adapter. When using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is required for proper operation and gas flow. If the plug is disconnected, the ventilator may not provide enough ventilation to the patient.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Baxter Advanced Respiratory customer service at 800-426-4224. Select option 2 for Acute Care Customer Service or option 3 for Home Care Customer Service.
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