Becton Dickinson Recalls Certain Infusion Pumps, Citing Issues With Cardinal Health's Syringes

Friday, the FDA said that Becton, Dickinson, And Company BDX is recalling its Alaris infusion pumps due to compatibility issues with Cardinal Health Inc's CAH Monoject syringes.

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.

The Alaris pumps are validated for use with 'Monoject' syringes. 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 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, resulting in over and under-infusions and/or delays in therapy.

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

The Alaris infusion pump is a modular system generally intended to deliver medications or other fluids.

In July, the FDA approved the BD Alaris Infusion System with 510(k) clearance, enabling remediation and a return to full commercial operations for the most comprehensive infusion system available in the U.S. 

In 2020, the company initiated an FDA Class I recall for the infusion pumps. The recall centered around multiple system, software, and use-related errors. 

Price Action: BDX shares are down 0.15% at $237.89 on the last check Monday.