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Fretting Corrosion Causes Recall of Drug Delivery Medical Device


EMSL Analytical provides medical device testing solutions for manufacturers to help prevent and identify potential problems. 
Cinnaminson, NJ, January 12th, 2012
This past November, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ikaria INOmax DS Drug Delivery System.  The device 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.
According to the FDA posting regarding the recall, “Fretting corrosion at the electrical contact interface of certain metals was 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.”
To resolve the situation the manufacturer implemented a service process change involving the application of an anti-corrosion lubricant specifically created to prevent fretting corrosion. The lubricant has been added to the preventive maintenance plan for all of the medical devices involved in the recall.
One company that has been instrumental in helping manufacturers of medical devices test their products and provide problem solving expertise is EMSL Analytical, Inc.  EMSL’s medical device testing laboratory is staffed with renowned scientists and the industry’s most advanced instrumentation.
“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,” reported Diane Miskowski, Business Development Manager at EMSL Analytical.   “EMSL’s medical device testing capabilities can help manufacturers prevent problems before they occur and help to identify the source of problems after the fact.  Medical device manufacturers who are faced with a product recall face potential legal action, negative publicity and potentially enormous costs associated with the occurrence.”
To learn more about medical device testing services please visit, email or call (800) 220-3675.
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of quality environmental and materials testing services and products to professionals and the general public.  The company is FDA registered, ISO 17025 and GMP compliant.


 medical device testing
 consumer products testing
 corrosion testing
 gmp compliant

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