FDA sticks Class I tag on Symbios' pump recall

Symbios Medical Products is recalling its GOPump Elastomeric Infusion PumpKit due to risks over over-infusion, and the FDA has slapped its most serious label to the effort, warning of injury and death. In some cases, the device's flow restrictor bead came loose, allowing solutions to flow at a faster than expected rate and putting patients at risk, according to the agency. Symbios informed customers of the problem last month, asking them to cease using the devices and send them back in, and the FDA affixed its Class I tag this week. More

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