Anesthesia

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.

Heather Linder

Friday, August 16th, 2013

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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