This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
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 use of affected product may cause serious adverse health consequences including a decrease in oxygen levels (desaturation) that can lead to injuries from lack of oxygen such as brain injury, heart attack, respiratory failure and death.
There have been no reported injuries or deaths.
