Battery problem prompts FDA Class 1 recall for infusion pumps

Editor's Note

The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death.

According to he agency’s August 20 announcement, the company is updating use instructions due to a manufacturing defect of the batteries, which are used when the pump is not plugged into AC power. This can result in interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.  This updated notice expands affected products from a March 2023 notice and now includes all replacement batteries manufactured by CSB. One injury and no deaths have been reported so far.

The large-volume infusion pumps deliver controlled amounts and rates of blood, drugs and other fluids through subcutaneous, intramuscular, intravenous, and intrathecal administration.