FDA Class I Recall: Alaris infusion pumps serviced by Tenacore

April 20, 2021

Tenacore is recalling the Alaris Pump because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients, reported the U.S. Food & Drug Administration (FDA). The FDA has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.

This affects the Alaris Infusion Pumps serviced by Tenacore, Models: Model 8100. The Alaris Pump is used to deliver fluids such as medications, nutrients, solutions, blood, and other therapies into a person’s body in controlled amounts. Bezel posts by Tenacore are used to service and repair infusion pump modules.

The separation of one or more bezel repair posts may result in:

·        free flow of fluids to patient

·         over delivery or under delivery of fluids delivered to a patient

·         interruption of fluids delivered to a patient

·         device leaking

·         device component burning or smoking

·         power supply failure or malfunction

If this device issue occurs, this could cause serious patient harm. There have been two complaints reported about this device issue. No injuries or deaths have been reported.

FDA has the recall.