October 2026 FDA Early Alerts: Presource Packs Require Warning Labels and Removal of Recalled BD Alaris Infusion Sets

On 20 October 2026, the U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), issued two early alerts concerning Presource procedure packs (convenience kits) manufactured by Cardinal Health. The packs contain BD Alaris pump infusion sets that are already covered by a separate recall. The action required at kit level is not a simple part replacement: inventory must be quarantined, a warning label must be affixed, clinicians must remove and discard the affected infusion sets, and distributors must notify their downstream customers.

What happened

On 20 October 2026, CDRH issued two early alerts concerning Cardinal Health Presource procedure packs. An early alert is not a formal recall classification. It is a notice that FDA publishes in advance when it considers that a high-risk problem may exist, and the page is updated as the investigation progresses. Both alerts address the same matter: certain Presource packs contain BD Alaris pump infusion sets, and those infusion sets are themselves within the scope of a separate recall.

Cardinal Health notified affected customers by letters dated 23 September 2026 and 24 September 2026. The letter of 23 September provided updated instructions for use, requiring customers to check inventory, review BD's published performance disclosures for the infusion sets, and adjust clinical practice, infusion set selection or pump use accordingly. The letter of 24 September set out a correction, requiring customers to quarantine the packs, inform clinical staff, and affix a clearly visible warning label to the front of each pack stating that healthcare professionals must remove and discard the recalled infusion set contained in the pack.

Why procedure packs are affected

Presource packs combine the devices, dressings and consumables required for a single surgical or interventional procedure into one packaged unit. Their particular characteristic is that the pack itself is usually not the failing component, but it encloses another manufacturer's component within its own packaging and lot numbering system.

The upstream issue: BD and CareFusion 303, Inc.

The upstream problem originates with BD and its subsidiary CareFusion 303, Inc. On 19 August 2026, BD issued an update letter to customers that supersedes the September 2025 field action MMS-25-5311. The affected products are infusion sets used with the BD Alaris Pump Module 8100, with Guardrails Suite MX software up to and including version v12.6.

According to BD, infusion sets with restrictive components, including closed male luer connectors, filters, one-way valves, Y-sites and microbore tubing, perform worse in actual use than previously published data indicated. The deviations occur most frequently at programmable rates below 1 mL/h and with bolus volumes of 5 mL or less. Subsequent BD testing found that previously claimed performance had been overstated, and in some scenarios by a wider margin.

Who is at risk

Performance deviations may result in under-infusion, over-infusion, delayed occlusion alarms and inaccurate bolus doses. These failure modes are not readily apparent to users at the point of care, and clinicians may attribute changes in a patient's condition to other causes.

The highest risk applies to neonates, infants and critically ill patients, who more frequently receive low-rate, small-volume infusions such as antiarrhythmic agents and vasopressors. FDA states that serious adverse events, including death, may occur in these populations. As of 19 August 2026, BD stated that it had not received reports of serious injury or death related to this issue.

On the BD infusion set recall page, FDA states that the recall has been classified as the most serious type and that continued use may cause serious injury or death.

Required actions at kit level

Under the Cardinal Health customer letters, organisations holding affected packs must first identify and quarantine the inventory, then inform clinical departments, and then affix a clearly visible warning label to the front of each pack stating that the recalled infusion set contained in the pack must be removed and discarded. Replacement labels may be requested from Cardinal Health. Where the holder is a distributor that has already resold the packs, it must also notify its own downstream customers.

The list of affected products is published by FDA as an attachment; the body of the alert does not enumerate each item. Whether a pack is affected depends on whether it contains a recalled Alaris infusion set, not solely on the kit's own model number.

Required actions at infusion set level

BD's customer letter sets out the actions in tiers. Annex C lists discontinued infusion sets and requires that they be identified and discarded immediately in accordance with the institution's procedures. Replacement infusion sets should be selected for clinical suitability for the specific use scenario. Where replacement stock is limited, priority should be given to critical care, neonatal, infant and paediatric units.

Where the existing infusion sets are not clinically suitable for use with the Alaris pump, another pump may be used, such as the Alaris Syringe Module or other syringe pumps. Where even syringe pumps are unavailable, recalled infusion sets may be used only with heightened clinical monitoring and adherence to the existing warnings.

Risk mitigation measures specified in the instructions for use

• Do not hang the infusion container below the pump module or more than 21 inches above the top of the pump module.
• During loading, ensure that the tubing is aligned directly with the pressure sensor.
• Confirm that all clamps are open, that the tubing outside the pump is not kinked or crimped, that drops are falling in the drip chamber, and that the vent is open where required.
• At rates below 10 mL/h, do not use the optional pressure mode set above 50 mmHg.
• When clearing an occlusion, first confirm that the fluid path to the patient is closed, then consider releasing pressure through a stopcock, weighing the risk of disconnecting the line against that of an inadvertent bolus.

Scope and limitations

This article reflects the content of the public documents issued by FDA and the two companies. Affected model numbers, lot numbers and the discontinued product list are set out in the tables in the FDA attachments. This article does not verify each model and lot individually and is not a substitute for an organisation's own comparison against its bill of materials and lot records.

AIMEILI regulatory interpretation

Although an early alert is not a formal recall classification, it is a signal that FDA considers a potentially high-risk problem to exist. The page is expected to be updated as the investigation proceeds, and the underlying component recall has already been characterised by FDA as the most serious type. Regulatory affairs teams should therefore treat the alert as an active field action for planning purposes rather than as preliminary information.

The most significant structural point is that the correction is addressed to the kit assembler, not only to the component manufacturer. FDA's position is that the organisation that places a component into its own packaging, labelling and lot system assumes responsibility for that component when it is subject to a field action. For kit manufacturers this translates into a requirement for systematic monitoring of supplier field actions and for mapping component-level recalls against bills of materials, finished-goods lots and unique device identification records.

Affixing a warning label is a labelling change implemented under a correction. It should be handled through documented change control, with label content verification, proof-of-application records and, where applicable, notification to the relevant regulators. Distributors carry an independent notification obligation, and records of downstream notification are routinely examined during inspections and are relevant to traceability requirements in the United States, the European Union and other markets.

Scope determination is component-based rather than kit-model-based. A defensible assessment therefore requires a bill-of-materials review that identifies every finished good containing the recalled Alaris infusion sets, including packs configured for specific clinical specialties and packs supplied under private label.

Business impact

• Operations: inventory quarantine, relabelling at pack level and possible removal of affected sets from kit configuration may interrupt kit assembly and release-to-market timelines, particularly where packs are built to order for scheduled procedures.
• Supply: limited availability of clinically suitable replacement infusion sets may affect kit supply for critical care, neonatal and paediatric customers, and may require documented allocation decisions and customer communication.
• Commercial and contractual: customer notifications, potential returns and exchange requests should be managed in line with supply agreements, with supplier indemnity and change-notification clauses reviewed against the timing of BD's August 2026 update letter.
• Regulatory and vigilance: any adverse events involving affected packs should be assessed for reportability under the applicable vigilance and post-market surveillance frameworks, and the alert should be captured as an input to post-market surveillance and risk management reviews.
• Clinical investigations: sponsors and CROs running studies at sites that use these packs should confirm whether affected inventory is present, assess the need for protocol deviation documentation, and evaluate any safety reporting implications.

Practical next steps for manufacturers, distributors and regulatory teams include auditing bills of materials against the FDA attachment, verifying that supplier change notifications reached the correct internal owners, updating supplier quality agreements to require timely notification of component field actions, and running a traceability exercise to confirm that affected finished goods can be located at lot level within the required timeframe.

Sources and verification

U.S. Food and Drug Administration (CDRH), Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets, issued 20 October 2026. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-cardinal-health-issues-correction-presource-packs-containing-bd-alaris-pump-infusion

U.S. Food and Drug Administration (CDRH), Early Alert: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets, issued 20 October 2026. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-cardinal-health-updates-use-instructions-presource-packs-containing-bd-alaris-pump

U.S. Food and Drug Administration (CDRH), Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets, page dated 5 October 2026. 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

Verification scope and access date: the three pages above were accessed on 25 October 2026, and the publication dates were checked against the FDA medical device recalls and early alerts listing pages.

Applicability note: this article is an interpretation of publicly available FDA regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Affected models, lots and disposal instructions are governed by the official texts and the companies' customer letters, and the information may change with subsequent official updates.