United StatesBlue Ventilator Adapter Module single‑patient use circuit (Product Code M07937, UDI/DI 00887761984622), an accessory for the Baxter Volara Respiratory Therapy system, sold in Florida (19 units), is affected. Baxter issued an urgent medical device correction because use in the home may lead to unrecognized oxygen desaturation or possible lung injury from overexpansion (barotrauma). Baxter is providing home caregivers with specific instructions for use.
What's being recalled
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Recalling firm: Baxter Healthcare Corporation, Deerfield, IL, United States.
How to identify it
UDI/DI number 00887761984622
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Florida
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)