U.S. FDA labels Baxter's respiratory device recall as most serious

[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.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

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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