TL;DR
Get health and wellness essentials delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
The FDA says BD and its subsidiary CareFusion are removing and discontinuing certain Alaris Pump Infusion Sets used with Alaris Pump Module 8100 systems. Updated testing found that some sets may deliver infusions less accurately or delay occlusion alarms, with risks that may be harder to recognize in vulnerable patients. As of Aug. 19, 2026, BD had reported no serious injuries or deaths associated with the issue.
The FDA says BD and its subsidiary CareFusion 303, Inc. are removing and discontinuing certain BD Alaris Pump Infusion Sets after updated testing found that some sets may perform worse than the company had previously reported. The agency classifies the action as its most serious type of recall, warning that continued use may cause serious injury or death, particularly when performance problems are difficult to recognize in patients receiving sensitive, low-rate infusions.
The affected sets are compatible with the BD Alaris Pump Module model 8100, used with BD Alaris software with Guardrails Suite MX up to version 12.6. BD’s updated customer letter, dated Aug. 19, 2026, replaces performance information previously provided in field action MMS-25-5311. The FDA says affected products include sets listed as discontinued in Attachment C of BD’s letter; the full affected-product list and customer instructions are available through the FDA notice and BD.
BD reported that sets with restrictive components or designs—including closed male luer connectors, filters, check valves, Y-sites and microbore tubing—may have worse performance than previously disclosed. The company’s testing found its earlier performance estimates were overstated and that performance was significantly worse in some cases. Deviations most commonly occur at programmable rates below 1 milliliter per hour and at or below 5 milliliters of bolus volume, according to the FDA summary.
Potential effects include under- or over-infusion, delayed occlusion alarms and inaccurate bolus doses. The FDA says those changes may not be readily detected by users and that the possible outcome depends on the circumstances and patient. As of Aug. 19, BD had reported no serious injuries or deaths associated with the issue.
Risks for Low-Rate Infusions
The notice matters because infusion pumps are used to deliver medicines and fluids continuously or intermittently, and errors in delivery can affect a patient’s treatment. The FDA says the risk may be greater for neonatal, pediatric and critically ill patients, who are more likely to receive low-rate or low-volume infusions, including medicines used to manage heart rhythm or support blood pressure.
The concern is not limited to whether a pump starts or stops. A set’s performance can affect the amount and timing of fluid delivered and how quickly an occlusion alarm sounds. If those effects are subtle, clinicians may not identify the set as the cause of a patient’s changing condition. The FDA’s warning about possible serious harm describes a potential risk; it does not mean that injury has been confirmed in reported cases.
Facilities also face a practical supply decision. BD and the FDA advise replacing discontinued sets with clinically appropriate alternatives, while prioritizing limited alternate supplies for critical-care, neonatal, infant and pediatric areas. Hospitals must weigh set availability and clinical suitability against the disclosed performance limitations and any risk from changing equipment or interrupting treatment.
As an affiliate, we earn on qualifying purchases.
Updated Data Replaces Earlier Disclosure
The FDA says BD continued testing Alaris Pump Infusion Sets to update performance information. That work led BD to report that earlier claims about set performance had been overestimated and that some results were substantially worse. The Aug. 19 customer letter replaces information in the company’s earlier field action, MMS-25-5311; it also updates instructions about which sets are to be removed and discontinued.
The Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for adult, pediatric and neonatal patients. According to the FDA, it can administer fluids through routes including intravenous, intra-arterial, subcutaneous and epidural delivery. The affected products are infusion sets used with the model 8100 pump module; the notice does not say that every Alaris set or every Alaris system is affected.
The FDA directs facilities to identify and discard the specific products named in BD’s discontinued-sets attachment, following their own procedures. It also advises reviewing BD’s performance disclosures and making appropriate changes to set selection, clinical use or pump use. If performance is not clinically appropriate, the letter recommends using another suitable pump, including an Alaris Syringe Module or another syringe pump when available.
“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
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Scope and Patient Effects
The FDA notice points readers to a full affected-product list, but the source material provided here does not reproduce every product name or identifier. Facilities and users should consult the FDA affected-product information and BD’s full customer letter to determine whether a specific set is included; the notice does not establish that all Alaris infusion sets are affected.
The available information also does not quantify how often performance deviations occur, how many patients or facilities may be affected, or the number of sets being removed. BD’s reported absence of serious injuries or deaths is limited to the status as of Aug. 19, 2026. The FDA material does not provide later case totals or state whether additional reports have since been received.
How much a particular set’s performance could affect a patient depends on the set design, programmed rate, clinical use and patient factors, according to the FDA summary. It remains unclear from the supplied material how quickly every affected facility can obtain suitable replacement sets or how long the removal process will take.
low-rate infusion sets for hospitals
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Facility Actions and Monitoring
Facilities should identify the sets named in Attachment C of BD’s letter and discard them under their established procedures. They should select a clinically appropriate alternate set for the relevant use case, prioritizing limited alternatives for critical-care, neonatal, infant and pediatric areas, and review the performance disclosures in Attachment B before deciding how to use remaining equipment.
BD’s letter also describes risk-mitigation steps for continued use where appropriate. These include keeping the solution container no lower than the pump module and no more than 21 inches above it; checking that tubing is positioned over pressure sensors, clamps are open and tubing is not kinked or collapsed; and following the stated pressure-mode limitation for low infusion rates. When clearing an occlusion, staff are instructed to stop fluid flow to the patient and weigh the risks of disconnecting the tubing to release pressure.
If a set’s performance is not clinically appropriate, the letter recommends an alternative pump, such as an Alaris Syringe Module or another syringe pump. If no syringe pump is available, the FDA summary says affected sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. The FDA notice points facilities to BD’s customer letter and user-manual risk-mitigation instructions; it does not specify a final deadline for completing removals.
As an affiliate, we earn on qualifying purchases.
Key Questions
Which products are included in the BD Alaris infusion set recall?
The notice concerns certain BD Alaris Pump Infusion Sets compatible with the Alaris Pump Module model 8100 and Alaris software with Guardrails Suite MX versions up to 12.6. Check the FDA affected-product list and BD’s customer letter for specific product identifiers; the notice does not say every Alaris set is affected.
Why are the infusion sets being removed?
BD’s updated testing found that some sets, especially designs with restrictive components, may perform worse than previously disclosed. Possible effects include inaccurate delivery, delayed occlusion alarms and bolus-dose errors.
What should a facility do with a discontinued set?
BD and the FDA advise facilities to identify sets listed in Attachment C of BD’s letter and discard them according to facility procedures. Facilities should choose an alternate set appropriate to the clinical use and prioritize limited alternatives for higher-risk care areas.
Have serious injuries or deaths been reported?
As of Aug. 19, 2026, BD had not reported any serious injuries or deaths associated with the issue, according to the FDA. That status is time-specific and does not rule out the potential harms described in the recall notice.
Can an affected set still be used if no alternative pump is available?
The FDA summary says that if no syringe pump is available, affected sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. Facilities should review BD’s full instructions and make decisions based on clinical suitability; this is not a general recommendation to continue using a recalled set.
Source: primary
Cold & flu season Picks
humidifiers
As an affiliate, we earn on qualifying purchases.
