Bio-Medical Equipment Service Recalls Part of Alaris Infusion Pump
The FDA has issued an update on a recall by Louisville, Ky.-based Bio-Medical Equipment Service for a component of the Alaris infusion pump that poses a potential safety risk.
The agency has deemed the recall of the Alaris pump module Model 8100 as Class I, the most serious type, because use of the defective item may cause serious injuries or death.
The pumps, which were distributed between July 10, 2020 and Feb. 18, 2021, are used to deliver fluids such as medications, nutrients, blood, and other therapies to patients.
The company is recalling the pumps because the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. No deaths, complaints or injuries were reported in connection with the recall, the FDA said.