U.S. FDA labels Baxter's respiratory device recall as most serious
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[June 24, 2022]
(Reuters) - The U.S. Food and Drug
Administration on Thursday classified the recall of some Baxter
International Inc's lung therapy devices as the most serious type after
reports of two deaths.
Medical device maker Baxter in late April recalled about 268 devices
distributed between May 28, 2020 and April 19, 2022.
The device, Volara, is used to deliver therapies for several conditions
such as for lung complications. Its ventilator adaptor component allows
the device to be used with ventilators in home-care settings.
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![](../images/062422PIX/health15.jpg)
Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly
![](http://archives.lincolndailynews.com/2022/Jun/24/images/ads/current/charrons_bch_2022.png) The FDA said the adaptor may prevent
patients from getting enough oxygen from their ventilators, and
possibly lead to death if caregivers are not trained properly.
(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)
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