| Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment. These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021. As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. | | | |
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