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# FDA Flags BD Alaris Infusion Sets Over Performance
- URL: https://www.fdaweb.com/fda-flags-bd-alaris-infusion-sets-over-performance/
- Published: 2026-10-06T17:35:19.000Z
- Updated: 2026-10-06T17:35:19.000Z
- Author: David McFarland
- Tags: Devices

FDA has updated a BD and CareFusion removal (Class 1 recall) of certain BD Alaris Pump infusion sets after additional testing found some sets can perform significantly worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms and inaccurate bolus doses. The Alaris system is used for continuous or intermittent administration of fluids and medications to adult, pediatric and neonatal patients through intravenous and other routes.

An agency [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-set-recall-bd-and-carefusion-303-inc-remove-bd-alaris-pump-infusion-sets?ref=fdaweb.com) notes that continued use of affected devices could cause serious injury or death, particularly among neonates, pediatric patients and critically ill patients receiving low-rate or low-volume infusions.

The action involves BD Alaris Pump infusion sets used with the BD Alaris Pump Module Model 8100 and Alaris with Guardrails Suite MX software through version 12.6\. FDA says BD notified customers that continued testing of the infusion sets showed previously claimed performance had been overestimated and that performance in some circumstances was “significantly worse.”

The problems are most likely to occur with sets containing restrictive components or designs, including closed male luers, filters, check valves, Y-sites and microbore tubing, the notice says. Deviations occur most commonly at programmable rates below 1 mL/hour and with bolus volumes of 5 mL or less.

The resulting performance problems can include greater degrees of under- or over-infusion, longer times before an occlusion alarm sounds and inaccurate bolus doses. FDA cautioned that the problems may be difficult for clinicians to recognize as the cause of a significant change in a patient's condition.

As of 8/19, BD had not reported any serious injuries or deaths associated with the issue.

BD and its CareFusion subsidiary have instructed customers to identify and discard discontinued Alaris Pump sets and use clinically appropriate alternatives. When supplies are limited, alternative sets should be prioritized for critical-care, neonatal, infant and pediatric settings.