US FDA says BD recalling infusion pumps due to compatibility issues

[December 02, 2023]  (Reuters) -The U.S. Food and Drug Administration (FDA) said on Friday that Becton Dickinson is recalling its Alaris infusion pumps due to compatibility issues with Cardinal Health's Monoject syringes.

The health regulator said 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.

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, the FDA said.

There have been 13 reported injuries but no death, the agency said.

Last month, the FDA warned healthcare providers not to use Cardinal's Monoject syringes with patient-controlled pain management pumps and syringe pumps after the company initiated a recall due to compatibility problems.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

On Sept. 15, BD asked its customers to stop using Cardinal's Monoject syringes with BD's Alaris pumps.

An infusion pump is a medical device that delivers fluids such as nutrients and medications into a patient's body in controlled amounts.

(Reporting by Christy Santhosh; Editing by Maju Samuel)

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