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Device RecallsRecall Brief

Class IOpen, Classified

FDA Expands BD Alaris Pump Infusion Set Class I Recall

FDA has expanded the Class I recall involving BD Alaris Pump Infusion Sets used with the Alaris Pump Module Model 8100 after updated testing showed that some sets may perform substantially worse than previously disclosed at low flow rates and low bolus volumes.

Type
Recall Brief
Published

Decision support

Decision summary

Official recall information is separated from MedTech Current editorial analysis.

Official recall information

What happened

FDA expanded its public communication on October 5, 2026. Updated testing found worse-than-disclosed performance with some Alaris Pump Infusion Sets, particularly below 1 mL/h and at bolus volumes of 5 mL or less. The September 15 database posting and August 19 initiation dates above refer to the latest Z-3080-2026 action.

MedTech Current analysis

Why it matters

Set components can change pump performance at the low rates and small bolus volumes used in neonatal, pediatric, and critical care. Under- or over-infusion, delayed occlusion alarms, and inaccurate boluses may be hard to recognize. Set selection and pump use need to reflect the updated performance disclosures.

Official recall information

Official actions

According to the updated FDA communication and BD instructions:

  • Immediately identify and discard infusion sets listed in Attachment C as discontinued.
  • Select clinically appropriate alternative Alaris sets when discontinued sets are removed.
  • Prioritize limited alternative-set supplies for critical-care, neonatal, infant, and pediatric areas.
  • Review the updated Pump Infusion Set Performance Disclosures and adjust clinical use, set selection, or pump use when necessary.
  • Use the BD Alaris Syringe Module or another clinically appropriate syringe pump when identified infusion-set performance is not suitable for the intended infusion.
  • If no syringe pump is available, use recalled pump infusion sets only with the caution, enhanced clinical monitoring, and previously communicated warnings described by BD.
  • Do not hang the solution container below the pump module or more than 21 inches above the top of the pump module.
  • When loading the set, ensure the tubing is positioned directly over the pressure sensors.
  • Ensure clamps are open, tubing outside the pump is free of kinks or collapse, and the vent is open when applicable.
  • Check that drops are flowing in the drip chamber.
  • At rates below 10 mL/h, do not set Selectable pressure mode above 50 mmHg.
  • When clearing an occlusion, stop fluid flow to the patient. Disconnect tubing to release excess pressure through a stopcock if present, weighing the risks of disconnection against those of an unintended bolus.
  • Circulate the notice to all facility areas using the sets and return the customer response form even if no affected material is held; the form also supports credit for discarded product.

Detailed recall information

Detailed sourced information from the published Recall Brief follows.

What changed

FDA expanded its BD Alaris Pump Infusion Set Class I recall communication on October 5, 2026, adding affected products and updating recommendations. BD testing found that some sets may perform worse than previously disclosed when used with the Alaris Pump Module Model 8100. The affected system includes BD Alaris with Guardrails Suite MX software versions up to v12.6.

The performance concern involves sets with restrictive components or designs, including closed male luers, filters, check valves, Y-sites, and microbore tubing. Deviations most commonly occur at programmed rates below 1 mL/h and bolus volumes at or below 5 mL. FDA states that the resulting performance differences may cause greater under- or over-infusion, delayed occlusion alarms, and bolus-dose inaccuracies that may be difficult for users to recognize.

For neonates, pediatric patients, and critically ill patients receiving low-rate or low-volume infusions such as antiarrhythmics or medications that support blood pressure, these deviations could result in serious adverse events or death. As of August 19, 2026, BD had reported no serious injuries or deaths associated with the issue.

Who and what are affected

The FDA communication covers BD Alaris Pump Infusion Sets compatible with the Model 8100 Pump Module and links multiple Class I recall actions: Z-3080-2026, Z-0035-2026, Z-2180-2025, and Z-2179-2025.

The affected-product list includes discontinued sets and sets that remain available with revised performance disclosures. FDA links the current complete product spreadsheet from its primary notice; earlier lists may not reflect the latest scope.

FDA lists BD SWITZERLAND SARL as the recalling firm for the latest Z-3080-2026 action and CareFusion 303, Inc. for the linked earlier actions. Z-3080-2026 concerns discrepancies in previously communicated infusion-set performance data. That action began on August 19, 2026, and was posted in the FDA database on September 15; October 5 is the public communication update date.

What affected organizations should do

Affected customers and facilities

According to BD’s August 19, 2026 customer communication, as summarized in FDA’s updated notice:

  • Immediately identify and discard infusion sets listed in Attachment C as discontinued.
  • Select clinically appropriate alternative Alaris sets when discontinued sets are removed.
  • Prioritize limited alternative-set supplies for critical-care, neonatal, infant, and pediatric areas.
  • Review the updated Pump Infusion Set Performance Disclosures and adjust clinical use, set selection, or pump use when necessary.
  • Use the BD Alaris Syringe Module or another clinically appropriate syringe pump when identified infusion-set performance is not suitable for the intended infusion.
  • If no syringe pump is available, use recalled pump infusion sets only with the caution, enhanced clinical monitoring, and previously communicated warnings described by BD.
  • Do not hang the solution container below the pump module or more than 21 inches above the top of the pump module.
  • When loading the set, ensure the tubing is positioned directly over the pressure sensors.
  • Ensure clamps are open, tubing outside the pump is free of kinks or collapse, and the vent is open when applicable.
  • Check that drops are flowing in the drip chamber.
  • At rates below 10 mL/h, do not set Selectable pressure mode above 50 mmHg.
  • When clearing an occlusion, stop fluid flow to the patient. Disconnect tubing to release excess pressure through a stopcock if present, weighing the risks of disconnection against those of an unintended bolus.
  • Circulate the notice to all facility areas using the sets and return the customer response form even if no affected material is held; the form also supports credit for discarded product.

MedTech Current analysis: The low-rate and small-bolus performance data matter to neonatal, pediatric, and critical-care infusions. Set components can alter delivery and alarm behavior, so set selection and pump use need to reflect BD’s updated disclosures. The response distinguishes discontinued sets that must be discarded from other affected sets whose use depends on the disclosed performance and clinical circumstances.