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FDA Issues Class I Recall on Infusion Technology Made by IRadimed Corporation


8/13/2013 11:51:39 PM

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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.

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.

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