FDA issues Class I recall on infusion technology made by Iradimed

August 13, 2013 by Sony Salzman

The FDA put a Class I recall warning on some of Iradimed's Mridium infusion pumps based on a glitch that displays the wrong infusion dose, an error that the agency warns might lead to serious injury or death.

FDA issues Class I recall on infusion technology made by Iradimed

Florida-based infusion device company Iradimed landed in hot water with some units of its MRidium infusion pumps, the FDA giving the measure it's highest-risk Class I recall status, a label reserved for the most serious device malfunctions that might result in death.

The recall only extends to MRidium 3860+ infusion pumps equipped with the company's dose error reduction system upgrade kit. During initial system setup certain keystrokes might override the control system, allowing for an over-dose or under-dose of medication, according to the FDA alert.

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In July the company called all hospitals and care centers using the device to warn them of the problem, and asked customers to temporarily remove the dose error reduction system from the MRidium 3860+ system.

The system will operate normally without the dose error reduction system in place, and Iradimed is asking customers to correct the problem with a software update. The recall does not affect other MRidium infusion systems, according to the FDA notice.