Recall Information

FDA

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.

Tenacore is recalling the Alaris Pump because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. 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.

Who May be Affected: Health care providers using the affected Alaris Pump serviced by Tenacore with a Bezel Assembly; and Patients who require care using the affected Alaris Pump serviced by Tenacore with a Bezel Assembly.

For more information, please visit: https://www.fda.gov/medical-devices/medical-device-recalls/tenacore-recalls-alaris-pump-bezel-assembly-and-alaris-infusion-pumps-repaired-bezel-assembly-due?utm_medium=email&utm_source=govdelivery