The U.S. Food and Drug Administration (FDA) just announced that the INOmax DS drug delivery system has been named in a Class I recall, its most serious and involving situations in which there is a reasonable probability that use of the Class I-recalled product will cause serious adverse health consequences or death.
The recalled Ikaria INOmax DS Drug Delivery System includes serial numbers DS20070005 – DS20100865. The product was manufactured from March 12, 2007 through February 2, 2011 and was distributed from September 4, 2007 through February 2, 2011. The recall was initiated by Ikaria Holdings, 6 State Route 173, Clinton, New Jersey 08809./
The INOmax DS Delivery System is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.
Fretting corrosion at the electrical contact interface of certain metals was found to be the root cause for erratic nitric oxide (NO) monitoring readings. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower-than-normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
The FDA noted that Ikaria implemented a service process change involving the application of DeoxIT, an anti-corrosion lubricant specifically created to prevent fretting corrosion. 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. On December 22, 2011, Ikaria sent a communication to health care professionals informing them of the completion of this action and that no further action was necessary. Ikaria Customer Care can be reached, toll-free, at 1.877.KNOW.INO (1.877.566.9466).
The FDA also indicated that, on December 22, 2011, Ikaria, Inc. announced it completed a remediation action for its INOMAX® DS drug-delivery systems related to a fretting corrosion. 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.