The FDA has designated Fresenius Kabi’s recall of its standalone infusion pump as Class I.
The firm is recalling the portable volumetric infusion pump over four software glitches and its alarm at the end of infusion. Fresenius said it will upgrade the software applications and boost the alarm at customer locations or at its service center.
The software problems can cause over- or under-infusion of fluids or medications which could lead to patient injury or death, the agency said.
