Navigation Links
Ikaria® Issues Notice of Completed Remediation for INOMAX® DS Drug-delivery System
Date:12/22/2011

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 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 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 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.

Contact:
Samina Bari
Ikaria, Inc.
(908) 238-6372
samina.bari@ikaria.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:7/12/2017)... July 12, 2017  Eli Lilly and Company (NYSE: ... generic companies to resolve pending patent litigation in the U.S. ... regarding the Cialis ® (tadalafil) unit dose ... 26, 2020. As part of the agreement, Cialis exclusivity is ... 2018. "The unit dose patent for Cialis is ...
(Date:7/11/2017)... , July 11, 2017  Sysmex America, ... urinalysis diagnostic testing equipment as well as middleware ... a way to make quality assurance easier and ... "Sysmex is well known for the innovation that ... Quality Monitor elevates quality assurance processes to a ...
(Date:7/10/2017)... -- The Institute for In Vitro Sciences (IIVS), a ... a VITROCELL® inhalation exposure system thanks to a generous ... which is designed to replace animals in inhalation testing, ... airborne test materials in an environment that mimics the ... testing combustible tobacco products, as well as next generation ...
Breaking Medicine Technology:
(Date:7/26/2017)... ... ... An inventor from Salisbury, N.C., knows the difficulties involved with leech therapy. "I ... to keep leeches in place during therapy," she said. "That’s why I came up ... to keep a leech in place on the skin during therapy. It prevents the ...
(Date:7/26/2017)... ... July 26, 2017 , ... Written By: Ashley D. Beall, ... in drug therapy for patients living with relapsing and primary multiple sclerosis that ... cell targeted therapy that has been proven to significantly reduce signs of disease ...
(Date:7/26/2017)... ... July 26, 2017 , ... Evergreen Healthcare ... of their continued efforts to provide innovative offerings to their healthcare partners. These ... and build dynamic, high-performing teams to address healthcare IT’s biggest challenges. , “Adding ...
(Date:7/26/2017)... ... July 26, 2017 , ... It may be hard to ... accessible to people in the third world. Diseases that many developed countries consider rare ... who don't have access to vaccines. , On an upcoming segment of "Success Files", ...
(Date:7/26/2017)... ... July 26, 2017 , ... ... 2017 Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland, 12 ... lifecycle challenges faced by process validation professionals and statisticians today. , “These ...
Breaking Medicine News(10 mins):