We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement

Ikaria INOmax DS Drug Delivery System: FDA Impose Class I Recall - Erratic Nitric Oxide (NO) Readings


Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Ikaria INOmax DS Drug Delivery System: FDA Impose Class I Recall - Erratic Nitric Oxide (NO) Readings"

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

Read time:
 

Affected serial numbers include DS20070005-DS20100865. This product was manufactured from March 12, 2007 through February 2, 2011 and distributed from September 4, 2007 through February 2, 2011.

BACKGROUND: 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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Advertisement