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FDA Puts Highest-Risk Category on Symbios Infusion Pump Recall

Tue, 03/19/2013 - 4:10pm
Mass Device

The FDA assigned Symbios Medical Products' infusion pump recall Class I status over concerns that a displaced restrictor bead could results in overdose.

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Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose.

The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.

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