Becton Dickinson (BD)/Carefusion 303 is recalling their Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes.

The Alaris pumps are validated for use with ‘Monoject’ syringes and list ‘Monoject’ as one of the options when the user is selecting a syringe type within the Alaris system. However, the dimensions for Monoject syringes have recently changed while rebranding the syringes from “Covidien Monoject” to “Cardinal Health Monoject.”

Cardinal Health branded Monoject syringes have not been validated for use with the BD Alaris Syringe and PCA modules. When one of these new syringes is used with the previous syringe settings, the pump may either refuse to operate or incorrectly estimate the volume of liquid in the syringe. This has resulted in over and under infusions, as well as delays in therapy.

Use of incompatible syringe sizes and models with the BD Alaris Syringe and PCA Modules can impact syringe pump operation resulting in inaccurate fluid delivery, delayed generation of occlusion alarms, and other potential problems.

The Alaris infusion pump is a modular infusion pump system generally intended to deliver medications or other fluids. The syringe and PCA pump modules are validated for use with specific syringes. On the Alaris system, the user enters the nominal volume of the syringe and selects the syringe brand from a library of compatible syringes. This instructs the PCU on which pre-loaded syringe dimensions to use when calculating the volume of fluid in the syringe.

On September 15, 2023, Becton Dickinson (BD) sent all affected customers an Urgent Medical Device Labeling Correction.

The letter asked customers to:

  • Stop use of Cardinal Health branded Monoject syringes with the BD Alaris Syringe and PCA Modules.
  • Replace the current BD Alaris Syringe and PCA Module Compatibility Lists with the updated compatibility lists attached to the letter.
  • Complete the Customer Response Form that was attached to the letter and return to the BD contact noted on the form to acknowledge receipt of this notification.

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. There have been 13 reported injuries. There have been no reports of death.