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Recall -- Firm Press Release
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IKARIA® Issues Notice of Completed Remediation For
INOMAX® DS Drug-Delivery System
FOR IMMEDIATE RELEASE - December 22, 2011 - Ikaria, Inc. announced today that it has completed a remediation action for its INOMAX® DS drug-delivery systems related to a fretting corrosion. This class I recall notice is being issued at the direction of the U.S. Food and Drug Administration (FDA). No further action is necessary.
There is a reasonable likelihood of serious adverse health consequences or death associated with the type of malfunction addressed in this recall. The associated health risks may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, ARDS, and neurological deficits.
In an investigation conducted by Ikaria in April 2010, it was determined that fretting corrosion, or micro-movement at the electrical contact interface of non-noble metals, such as tin, was the root cause for erratic nitric oxide (NO) monitoring readings which were reported when the INOMAX DS was used for NO delivery to patients. As a result, Ikaria implemented a service process change involving application of DeoxIT®, an anti-corrosion lubricant specifically formulated to prevent fretting corrosion, to the flex cable/connector of the monitoring circuit board of the INOMAX DS to effectively mitigate the observed erratic readings of NO monitoring. Specifically, replacement of the ribbon cable with application of DeoxIT was added to the preventive maintenance plan for all INOMAX DS drug-delivery systems and was performed when the systems rotated through Ikaria’s Regional Service Centers for any routine service activity. This issue did not affect the INOvent® or INOMAX DSIR drug-delivery systems.
Ikaria sent a communications to healthcare professionals on December 22, 2011 informing them of the completion of this action, and that no further action is necessary. This notice is available at www.inomax.com or www.ikaria.com . Customers with questions regarding this notice may contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) for assistance.
“Ikaria is committed to insuring the continued safe and effective delivery of INOMAX and we have conducted a timely and orderly replacement of the affected INOMAX DS systems,” said Daniel Tassé, Chairman and CEO of Ikaria.
Adverse reactions associated with the use of these products may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
About Ikaria, Inc.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients in the hospital and ICU settings. The company’s lead product is INOMAX® (nitric oxide) for inhalation, the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term infants. It is offered through the INOMAX therapy package, an all-inclusive offering of drug product, drug-delivery system, on-site training and 24/7/365 technical assistance and support. The INOMAX therapy package also is marketed in Puerto Rico, Canada, Australia, Mexico and Japan. The company is pursuing a number of new indications for inhaled nitric oxide. Ikaria’s late-stage pipeline is also comprised of LUCASSIN® (terlipressin), a potential treatment for hepatorenal syndrome Type 1; as well as IK-5001, a potential treatment for preventing cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction. Ikaria is headquartered in Hampton, NJ, with a research facility in Madison, WI, and manufacturing facilities in Port Allen, LA and Madison, WI. Please visit www.ikaria.com .
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.