52K infusion pumps recalled

Medical devicemaker InfuTronix is recalling 52,328 infusion pump systems after receiving nearly 3,700 complaints about various failures. 

The products, which are marketed as Nimbus Administration Set, Flex, and PainPro/Halo Ambulatory Infusion System, as well as Nimbus II PainPRO, Flex, Plus, EpiD, and EMS, are part of a Class I recall — the most serious type. The sets are used to deliver medications and fluids to patients in hospitals, other healthcare sites and patient homes, the FDA said April 25. 

The reported issues include "battery failure, upstream blockage, system errors, drug product leakage, high or low flow rate, or damaged housing," the FDA said. InfuTronix notified customers in February, and the sets will not be available after June 20.

Six serious injuries and one death have also been reported. 

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