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BD and CareFusion have updated their recall guidance for certain BD Alaris Pump Infusion Sets used with Alaris Pump Module Model 8100. The FDA classifies the action as its most serious type; BD said updated testing found some sets performed worse than previously disclosed. As of Aug. 19, 2026, BD had reported no serious injuries or deaths linked to the issue.
BD and its subsidiary CareFusion 303, Inc. have updated a recall affecting certain infusion sets used with the BD Alaris Pump Module Model 8100, directing health care facilities to discard specified sets and review how other affected sets are used. The FDA identifies the action as its most serious type of recall, warning that continued use may cause serious injury or death; BD reported no serious injuries or deaths associated with the issue as of Aug. 19, 2026.
The update follows BD testing that found some Alaris infusion sets with restrictive components or designs performed worse than the company had previously disclosed. Examples include sets with closed male luer connectors, filters, check valves, Y-sites or microbore tubing. BD said the new performance information replaces data previously communicated in field action MMS-25-5311.
The FDA says the affected products are BD Alaris Pump Infusion Sets compatible with Model 8100, used with BD Alaris and Guardrails Suite MX software versions up to v12.6. The FDA page directs facilities to consult the affected-product list and BD’s customer letter for the specific sets covered, including those designated for discontinuation.
In a letter dated Aug. 19, 2026, BD and CareFusion told affected customers to identify and discard sets listed in Attachment C, then select a clinically appropriate alternate set for the particular use. If alternate sets are in short supply, the companies said facilities should prioritize them for critical-care, neonatal, infant and pediatric areas. They also advised reviewing the performance disclosures and adjusting set selection, clinical use or pump use as needed.
Risks in Low-Rate Infusions
The performance differences matter because they may affect how much fluid or medication reaches a patient and how quickly an occlusion alarm sounds. According to the FDA’s summary of BD’s findings, issues may include under- or over-infusion, delayed occlusion alarms and inaccurate bolus delivery. The company said deviations were most commonly seen at programmable rates below 1 mL per hour and at bolus volumes of 5 mL or less.
Such infusion conditions can be used to deliver medicines that require careful dosing, including drugs used to support blood pressure or treat abnormal heart rhythms. The FDA notes that neonates, children and critically ill patients may be especially vulnerable because they are more likely to receive lower-rate or lower-volume infusions. The agency warns that, depending on patient and use circumstances, the consequences could include serious adverse events or death; that is a risk warning, not a report that such outcomes have occurred in this recall.
Facilities may need to check inventory, identify affected product codes and coordinate replacement sets with clinical teams. The guidance also gives alternatives for situations in which a particular set-and-pump combination is not clinically appropriate, while recognizing that supply limits can complicate replacement.
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Updated Testing Replaces Earlier Data
The BD Alaris System is a modular infusion pump and monitoring system designed to deliver fluids continuously or intermittently to adult, pediatric and neonatal patients. The FDA says it can be used through clinically accepted routes including intravenous, intra-arterial, subcutaneous and epidural administration, as well as irrigation of fluid spaces.
BD continued testing its infusion sets to update performance information on accuracy. The company said the testing showed that previously stated performance had been overestimated and that performance was significantly worse in some instances. The revised disclosures replace information in the earlier field action identified as MMS-25-5311. The FDA’s recall notice includes links to affected-product information and related enforcement and recall database entries; facilities are directed to use the current product list and customer letter rather than rely on earlier performance figures.
The recall action involves removing certain products from use or sale, but it does not mean every Alaris set or every use of the pump is affected in the same way. The specific set design, infusion rate, bolus volume and clinical circumstances shape the performance concerns described in the update.
“The previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.”
— BD, as summarized by the FDA
infusion set replacement for BD Alaris
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Scope and Patient Outcomes
The exact products affected must be confirmed against the FDA’s affected-product spreadsheet and BD’s customer letter; the available notice refers readers to those materials for the full set list. The FDA summary does not provide a total number of affected sets, facilities or patients, nor does it specify how many sets have been removed or replaced.
BD had reported no serious injuries or deaths as of Aug. 19, 2026. That status does not establish whether less serious events occurred or whether additional reports could emerge. The notice also does not quantify how often the performance deviations occur across all affected sets or provide a single risk estimate applicable to every patient and infusion.
Facilities must determine whether particular products and use conditions are clinically appropriate. The FDA and company guidance describe potential performance problems and mitigation steps, but the notice does not state that every use of an affected set will result in an infusion error.
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Facility Checks and Set Replacement
Health care facilities should compare their inventory with the current affected-product list, follow their procedures to discard sets identified as discontinued, and arrange clinically appropriate alternatives. BD and CareFusion also direct users to review the performance disclosures in Attachment B and make any necessary changes to set selection or pump use.
The customer guidance includes risk-mitigation steps for continued use where appropriate. For example, it advises keeping the solution container from hanging below the pump module or more than 21 inches above it, positioning tubing directly over pressure sensors, and checking that clamps are open and tubing is not kinked or collapsed. It also cautions against certain selectable pressure-mode settings for low-rate infusions and gives instructions for managing an occlusion, including turning off fluid flow to the patient before addressing it. These directions should be read in the context of the applicable user manual and customer letter.
If performance with an identified set is not clinically appropriate, the guidance recommends using another pump, such as the BD Alaris Syringe Module or an alternative syringe pump. If no syringe pump is available, the FDA’s summary says the affected sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. Further updates may follow as the company and FDA continue to provide recall information; the notice does not give a specific deadline for completing facility reviews.
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Key Questions
Which products are included in the recall?
The notice covers certain BD Alaris Pump Infusion Sets compatible with Alaris Pump Module Model 8100, with BD Alaris and Guardrails Suite MX software versions up to v12.6. Check the FDA affected-product list and BD’s customer letter for the specific product identifiers and discontinued sets.
What should a facility do with discontinued sets?
BD and CareFusion told affected customers to identify and discard sets listed in Attachment C of the customer letter, following the facility’s procedures. Facilities should select a clinically appropriate alternate set for the use case and prioritize limited alternatives for critical-care, neonatal, infant and pediatric areas.
What performance problems were found?
BD said some sets performed worse than previously disclosed, with concerns that can include under- or over-infusion, delayed occlusion alarms and bolus inaccuracies. The FDA summary says deviations were most commonly observed at rates below 1 mL per hour and bolus volumes of 5 mL or less.
Have serious injuries or deaths been reported?
As of Aug. 19, 2026, BD had not reported serious injuries or deaths associated with the issue, according to the FDA. The agency still warns that continued use of affected devices may cause serious injury or death under some circumstances.
Can affected sets still be used?
The guidance says use should depend on the specific set and clinical circumstances. If performance is not clinically appropriate, it recommends an alternative pump. Where no syringe pump is available, the FDA’s summary says affected sets may be used with caution, enhanced monitoring and adherence to the stated warnings and risk-mitigation instructions.
Source: primary
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