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BD and its subsidiary CareFusion updated guidance on the removal of certain BD Alaris Pump Infusion Sets compatible with Model 8100 pumps. The FDA classifies the recall as its most serious type, citing risks including inaccurate delivery, delayed occlusion alarms and unintended boluses; as of August 19, 2026, BD had reported no serious injuries or deaths associated with the issue.
BD and CareFusion 303, Inc. have updated instructions for removing certain BD Alaris Pump Infusion Sets used with Alaris Pump Module Model 8100 after testing found that some sets may perform worse than previously reported. The FDA identifies the action as its most serious type of recall and warns continued use could cause serious injury or death, particularly for vulnerable patients receiving low-rate or low-volume infusions.
The affected products are BD Alaris Pump Infusion Sets compatible with Model 8100, used with BD Alaris software that includes Guardrails Suite MX versions up to v12.6. The FDA says BD’s updated customer letter replaces performance information previously communicated in field action MMS-25-5311. It also includes updated information about removal and discontinuation of certain sets. Facilities should consult BD’s customer letter and the FDA’s affected-product materials to identify the specific products involved.
BD’s testing found that infusion performance for some sets with restrictive components or designs—including filters, check valves, Y-sites, microbore tubing and closed male luers—was worse than the company had previously disclosed. The FDA says deviations most commonly occur at programmable rates below 1 mL per hour and at bolus volumes of 5 mL or less. The potential effects include greater under- or over-infusion, delayed occlusion alarms and inaccuracies in bolus delivery.
In a letter dated August 19, 2026, BD and CareFusion advised affected customers to identify and discard sets listed as discontinued in Attachment C, following their facilities’ procedures. They also advised reviewing the performance disclosures and adjusting clinical use, set selection or pump use as needed. If an appropriate alternate set is in short supply, the companies recommend prioritizing its use for critical-care, neonatal, infant and pediatric patients.
Risks for Patients on Low-Rate Infusions
The issue concerns how reliably an infusion set delivers medication and how promptly a pump signals a possible blockage. Under- or over-infusion, a delayed alarm or an inaccurate bolus could affect care, and the FDA says these problems may be difficult for users to recognize as the cause of a patient’s changing condition.
The agency highlights neonatal, pediatric and critically ill patients as especially vulnerable. These patients may receive small volumes or low-rate infusions of medicines such as antiarrhythmics or drugs that support blood pressure. The FDA says potential outcomes depend on several factors; it warns that serious adverse events or death could occur in higher-risk patients. This is a statement about potential risk, not a report that such outcomes have occurred in this recall.
For hospitals and other facilities, the alert calls for more than removing discontinued products: staff may need to review set selection, infusion procedures and whether a different pump is appropriate for a particular use. The operational challenge is to follow the product-specific instructions while preserving access to clinically appropriate equipment, especially in high-acuity areas.
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How BD Revised Its Performance Data
The BD Alaris System with Guardrails Suite MX is a modular system for continuous or intermittent delivery of fluids to adult, pediatric and neonatal patients. It can be used through several clinically accepted routes, including intravenous, intra-arterial, subcutaneous and epidural administration, as well as irrigation of fluid spaces. The recalled products are infusion sets used with Model 8100; the FDA’s notice does not say the entire Alaris system is being removed.
BD continued testing its infusion sets to update performance data for accuracy. According to the FDA’s account of the company’s findings, some previously stated performance was overestimated, with some sets performing significantly worse in certain conditions. The revised disclosure supersedes the performance information sent in an earlier field action. The updated guidance also covers discontinued sets and risk-reduction steps for continued use where appropriate.
As interim precautions, the customer letter and user-manual guidance address container height, tubing placement over pressure sensors, open clamps and unobstructed tubing. They also warn against using selectable pressure mode above 50 mmHg at rates below 10 mL per hour. When clearing an occlusion, clinicians are instructed to stop fluid flow to the patient and consider how to release excess pressure safely. These steps are not a substitute for identifying and discarding discontinued sets or following facility procedures.
“The previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.”
— BD, as described in the FDA notice
Injury Reports and Product Scope
As of August 19, 2026, BD had not reported any serious injuries or deaths associated with this issue, according to the FDA. That status does not establish that the products carry no risk; the agency’s warning concerns possible outcomes if affected sets continue to be used.
The notice does not give a total number of affected sets, the number of facilities that received the letter, or a complete account of how many sets are being discontinued. Product identification depends on the detailed affected-product list and BD’s attachments, which facilities should check directly. The notice also does not provide case-by-case estimates of how often a performance deviation may occur or quantify the risk for an individual patient or infusion.
It remains a clinical decision whether performance with a particular set is appropriate for a particular use. The FDA says facilities should review the disclosures and make necessary adjustments; if performance is not clinically appropriate, it advises use of another pump, such as the BD Alaris Syringe Module or an alternative syringe pump when available. The notice does not specify how long supplies of alternate sets or pumps will take to replenish.
Facility Actions and Ongoing Review
Facilities should compare their inventory with the discontinued-set list and affected-product spreadsheet, remove and discard listed sets under their procedures, and review the full customer letter’s performance disclosures. They should select a clinically appropriate alternate set for each use case and prioritize limited alternate supplies for critical-care, neonatal, infant and pediatric areas.
Where the disclosed performance is not clinically appropriate, the FDA relays BD’s recommendation to use a different pump, including the Alaris Syringe Module or an alternative syringe pump if available. If no syringe pumps are available, the notice says recalled sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. It also directs users to risk-mitigation steps in the v12.3–v12.6 Alaris Infusion System user manual.
Hospitals should follow the detailed instructions from BD and the FDA rather than relying on a product description alone. The FDA notice links to BD’s customer letter and affected-product information, as well as recall database entries. Further updates may clarify product scope or performance information; the notice does not give a date for a new update.
Key Questions
Which products are covered by the recall?
The notice covers BD Alaris Pump Infusion Sets compatible with Alaris Pump Module Model 8100, used with BD Alaris software and Guardrails Suite MX versions up to v12.6. Check the FDA affected-product materials and BD’s customer letter for specific set identifiers and discontinued products.
What should a facility do with discontinued sets?
BD and CareFusion advise facilities to identify and discard sets listed in Attachment C of the customer letter according to facility procedures. They also recommend choosing a clinically appropriate alternate set for the intended use.
What performance problems did testing identify?
The FDA says some sets with restrictive components or designs performed worse than previously disclosed, particularly in some low-rate or low-volume conditions. Possible effects include under- or over-infusion, delayed occlusion alarms and inaccurate bolus delivery.
Have serious injuries or deaths been reported?
According to the FDA notice, BD had reported no serious injuries or deaths as of August 19, 2026. The agency nevertheless warns that continued use could pose serious risks, especially for vulnerable patients.
What if an alternate pump is not available?
The notice says recalled sets may be used with caution if no syringe pumps are available, with enhanced clinical monitoring and adherence to existing warnings. Facilities should review BD’s full instructions and apply clinical judgment; the FDA does not provide a single alternative suitable for every patient or use case.
Source: primary
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