US FDA classifies recall of Vyaire Medical's respiratory devices as most serious

[March 22, 2024]  (Reuters) -The U.S. Food and Drug Administration on Thursday classified the recall of privately held Vyaire Medical's respiratory support devices as most serious and said their use could cause major injuries or death.

The medical equipment maker recalled certain models of its AirLife Manual Resuscitators, a single patient-use device intended for respiratory support, due to a manufacturing defect.

The use of the recalled devices could result in patients not receiving enough ventilation, which may lead to a drop in blood oxygen levels, the health regulator said.

Vyaire did not immediately respond to a Reuters request for comment.

The manufacturing defect was corrected in 2017, but devices distributed before the correction may still be in use, according to the FDA.

The agency said there have been 37 reported incidents related to the recalled devices, including two injuries and two deaths.

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009.REUTERS/Jason Reed/File Photo

Vyaire started the recall process on Dec. 6 last year and has recalled over 6.6 million devices in the United States. The recalled devices were either without a manufacturing date or were manufactured before 2017.

(Reporting by Mariam Sunny in Bengaluru; Editing by Devika Syamnath)

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