OPIC: Alaris Infusion Pump Module 8100 Bezel by Bio-Medical Equipment Service: Class I Recall – Due to Possible Cracked or Separated Bezel Repair Posts
AUDIENCE: Patient, Health Professional, Risk Manager
ISSUE: Bio-Medical Equipment Service Co. is recalling the affected products and devices because the 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 a patient
- Over-delivery or under- delivery of fluids delivered to a patient
- Interruption of fluids delivered to a patient
If this device issue occurs, it could cause serious patient harm.
There have been no deaths, complaints, or injuries reported for this recall.
This recall is related to Tenacore’s recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: The Alaris Infusion Pump Module Model 8100 is used to deliver fluids such as medications, nutrients, blood, and other therapies into a person’s body, in controlled amounts. The bezel component is critical to the proper performance of the infusion pump. Bezels from Bio-Medical Equipment Service Co. are used to service and repair infusion pump modules.
RECOMMENDATIONS: On February 25, 2021, Bio-Medical Equipment Service Co. sent a recall notification letter via email. Similar to the Tenacore recall notification, the letter requ