Navigation Links
Ikaria® Issues Notice of Completed Remediation for INOMAX® DS Drug-delivery System

HAMPTON, N.J., Dec. 22, 2011 /PRNewswire/ -- 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 or  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 Tasse, 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

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

Samina Bari
Ikaria, Inc.
(908) 238-6372

SOURCE Ikaria, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ikaria® to Present at 2011 Lazard Capital Markets Healthcare Conference
2. Ikaria® CEO Daniel Tasse Elected to PhRMA Board of Directors
3. Ikaria® to Present at 2011 Wedbush Life Sciences Management Access Conference
4. Ikaria® Launches Next-Generation Drug-Delivery System
5. Ikaria® to Present at 31st Annual Cowen and Company Healthcare Conference
6. Ikaria® Names New Chief Financial Officer
7. 2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management
8. FDA Issues Warning Letters for Misleading Advertising of Lap-Band
9. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
10. VolitionRX Limited Issues 525,000 Shares to ValiRx; Final Requirement of Share Purchase Agreement
11. U.S. Patent Office Issues Notice of Allowance for Patent Application Related to CTIs GlycoPolymer Technology
Post Your Comments:
(Date:11/30/2015)... 1, 2015 Express Scripts (NASDAQ: ESRX ) ... IMMY ) to drive access to a low-cost alternative to ... toxoplasmosis that has been recently priced out of reach for ... systems. --> --> Imprimis ... (a form of folic acid) for $1 per capsule for people ...
(Date:11/30/2015)... , Nov. 30, 2015  QT Vascular Ltd., ... and together with its subsidiaries, TriReme Medical LLC and ... company engaged in the design, assembly and distribution of ... vascular disease, is pleased to announce that a three-judge ... Court of Appeals for the Federal Circuit ("Federal Circuit") ...
(Date:11/30/2015)... --  Royal Philips  (NYSE: PHG ; AEX: ... a fully integrated, consultative approach to enhance radiology ... management approaches that combine imaging systems, services, informatics ... delivery and reduce costs. Making its debut at ... Annual Meeting (RSNA) in Chicago ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... 30, 2015 , ... According to research by the National ... technicians to be certified or obtain continuing education. To increase awareness of the ... Mouth?” campaign to inform dentists that the technicians they trust could lack the ...
(Date:11/30/2015)... MN (PRWEB) , ... November 30, 2015 , ... ... at . The directory is specialized and only includes chiropractic clinics ... to find a competent and trustworthy alternative health practitioner when back pain sets ...
(Date:11/30/2015)... ... November 30, 2015 , ... The ... this summer, ushering in a new era of publicly accessible automated technology. Now, ... will continue to offer guests an up-close look at the shuttle at MOSI’s ...
(Date:11/30/2015)... Flint, Michigan (PRWEB) , ... November 30, 2015 ... ... a safe and fun atmosphere for Halloween festivities, the Word of Life Christian ... classic children’s board game, and featuring a giant 1.25 ton pile of candy ...
(Date:11/30/2015)... Alexandria, VA (PRWEB) , ... November 30, 2015 ... ... the mesothelioma-affected community across the United States to access life-saving information ... on Malignant Mesothelioma will consist of three individual conferences in three major ...
Breaking Medicine News(10 mins):