FDA Issues Class 1 Recall for Iradimed Infusion System

The FDA issued a Class 1 recall for the MRidium 3860+ Infusion System by Iradimed Corporation because the Dose Error Reduction System can give incorrect information regarding the value of the pump infusion rate, according to the American Society of Anesthesiologists.

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Adverse events, including death, could result from over- or under-infusion. The affected products were distributed between Oct. 6, 2011, and June 28.

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