Class I Medical Device Recall: Ikaria Holdings, INOMAX DS Drug Delivery System
Posted Aug 22 2010 9:00pm
Recall Class: Class I
Date Recall Initiated: July 21, 2010
Product: INOMAXDS Drug Delivery System, model 10003
These products were distributed from August 20, 2007 through July 15, 2010.
Use: The product delivers INOMAX (nitric oxide) to help patients breathe.
Recalling Firm: Ikaria Holdings
6 State Route 173
Clinton, New Jersey 08809
Reason for Recall:
A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. An interruption or delay in the administration of INOMAX therapy may cause:
Worsening of low blood oxygen level (hypoxemia)
Low blood pressure (hypotension) and/or
Increase in blood pressure in the pulmonary arteries (pulmonary hypertension)
Public Contact: Customers with questions may contact Ikaria Customer Care at 1-877-KNOW-INO (1-822-566-9466).
FDA District: Minneapolis
On July 21, 2010, the company sent their customers a recall notice which described the steps intended to reduce the potential risks associated with a system failure. This notice was also posted on the INOMAX webpage www.inomax.com or www.ikaria.com . The notice described the issue, how to recognize the problem, what to do, and described the long-term fix of replacing all INOMAX DS drug-delivery systems.
The company’s August 9, 2010 press release contained the following recommendations:
“If a leak is suspected, clinicians should: 1) not interrupt the delivery of INOMAX; 2) verify an adequate amount of INOMAX remains in the cylinder; 3) switch to the manual back-up system using the INOblender® by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation, and; 4) contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) for assistance.”
“Although the risk of INOMAX exposure to pregnant women is unknown, it is advised that healthcare professionals who may be pregnant avoid the immediate area in which a leak is suspected.”
Ikaria has already begun the replacement process of all INOMAX DS drug-delivery systems with remediated INOMAX DS systems. This recall does not apply to the INOvent® drug-delivery system.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.