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Ikaria receives Class I notice for drug delivery system recall

This article was originally published in Clinica

Executive Summary

Biotherapeutics firm Ikaria has been given a Class I notification from the US FDA after it recalled its Inomax DS drug delivery system. During ongoing review processes the firm discovered that a component within the pressure switch of the system is prone to tearing. This could cause worsening of low blood oxygen, low blood pressure and/or an increase in pulmonary arterial pressure, and death. The company informed customers of the fault on 21 July. The recall affects products distributed from 20 August 2007 to 15 July 2010 and is in effect in the US and Canada. The Clinton, New Jersey-based firm has begun to replace the systems. The Inomax DS system is designed to deliver nitric oxide to patients to help them breathe.

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