Fresenius Kabi USA recalled 1,546 large infusion pumps in a Class I recall, the most serious type, because of a risk of leaking products entering the electrical system and shutting down the device.
The company's Ivenix Infusion System is used in hospitals and other healthcare facilities "to give fluids to patients in precisely controlled infusion amounts and rates," including blood, drugs and other fluids to a patient's back or under the skin, the FDA said.
If the liquid leaks into the electrical component, the system can lose power, leading to delayed or interrupted treatments. As of April 19, there are 14 complaints, zero injuries and zero deaths related to this recall, according to the FDA.