Ikaria® Recalls INOMAX® DS Drug-Delivery System
Tue, 10 Aug 2010 17:05:00 -0500
Ikaria, Inc. announced today that its INOMAX® DS drug-delivery systems in the United States are being voluntarily recalled due to the potential failure of a pressure switch which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients. This potential failure was identified by Ikaria as part of its ongoing quality monitoring and review processes. This class I recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · 10903 New Hampshire Ave MD 20993 · 800-439-1420
