FDA: Class I recall of Alaris Infusion Pump Module 8100

Editor's Note

The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious.

The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to inaccurate delivery of fluids to patients.

The infusion pump is used to deliver fluids, such as medications, nutrients, blood, and other therapies to a patient in controlled amounts. The front bezel component is critical to the proper performance of the infusion pump.

There have been 62 complaints and one death that may have been related to the infusion pump. Distribution dates were July 10, 2020 to February 18, 2021.