Alaris Infusion Pump Bezel Recalled for Cracked Bezel Repair Posts by Pacific Medical Group

U.S. Food and Drug Administration sent this bulletin at 04/30/2021 01:00 PM EDT

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FDA - Center for Devices and Radiological Health

Pacific Medical Group (Avante Health Solutions) Recalls Alaris Pump Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Parts

Pacific Medical Group (DBA Avante Health Solutions) is recalling the Alaris Infusion Pump Module Model 8100 Front Bezel because the front bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. The separation of one or more bezel posts may result in free flow of fluids to patient, over delivery or under delivery of fluids delivered to a patient, or interruption of fluids delivered to a patient.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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Questions?

If you have questions about this recall, contact the Division of Industry and Consumer Education (DICE).