INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow
MedSun: Newsletter #52, September 2010
FDA MedWatch Safety Alert
There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients. 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.
Additional Information:
FDA MedWatch Safety Alert. INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow. August 23, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223746.htm