PharmacovigilanceOfficial

FDA classifies Cardinal Health Presource kit correction as Class I over BD Alaris infusion sets

🇺🇸 FDA MedWatch · Mon 09 Nov 2026

The FDA has upgraded its Early Alert on Presource convenience kits containing BD Alaris Pump infusion sets to a Class I recall, its most serious category.

The US Food and Drug Administration updated its communication on 9 November 2026 to classify Cardinal Health's correction of certain Presource convenience kits as a Class I recall. The agency had first flagged the issue in an Early Alert on 20 October. It says the affected products and its recommendations have not changed. It also says the action involves updating use instructions, not removing devices from where they are used or sold.

Cardinal Health wrote to affected customers on 23 September. It said some Presource kits contain BD Alaris Pump infusion sets covered by the separate BD and CareFusion 303 infusion set recall. Presource kits are packaged for a single surgical or medical procedure and hold instruments, dressings and other materials, including pharmaceutical components.

The underlying problem was identified by BD. Some Alaris Pump sets with restrictive components or designs, such as closed male luers, filters, check valves, Y-sites and microbore tubing, perform worse than previously disclosed. The deviations are most common at programmed rates below 1 mL/h and at bolus volumes of 5 mL or less. BD's further testing found that its earlier performance claims were overestimated and, in some cases, performance is significantly worse. The FDA says these deviations may not be readily detected by users.

According to the FDA, the performance differences could cause greater under- or over-infusion, delayed time to occlusion alarms and inaccurate bolus doses. Neonates, paediatric patients and the critically ill are most at risk, because they are more likely to receive low-rate or low-volume infusions, such as antiarrhythmics or blood-pressure support. As of 19 August 2026, BD had reported no serious injuries or deaths linked to the issue.

Cardinal Health tells customers to review the BD customer letter, including the Pump Infusion Set Performance Disclosures in its Attachment B, and to adjust clinical use, set selection or pump use as needed. If performance is not clinically appropriate, an alternative pump such as the BD Alaris Syringe Module, or another syringe pump, should be used. If none is available, the sets may be used with caution, enhanced clinical monitoring and adherence to earlier warnings. The communication also summarises risk-mitigation steps from the v12.3–v12.6 BD Alaris Infusion System User Manual on rate and bolus accuracy, time to alarm and post-occlusion bolus volume. US customers with questions or quality problems should contact their Cardinal Health sales representative.

What it means for your team

  • Quality and supply teams should identify Presource kits in inventory that may contain BD Alaris Pump infusion sets. The FDA says no removal from use is required.
  • Clinical and biomedical teams should review BD's Attachment B performance disclosures, along with the manual's risk-mitigation steps. They should consider whether set selection, pump choice or monitoring needs to change, particularly for low-rate infusions in neonates, paediatric and critically ill patients.
  • Vigilance teams should be aware of the Class I classification, the FDA's most serious recall category. Adverse events and quality problems can be reported to MedWatch and to Cardinal Health sales representatives.
  • Organisations should track both the BD recall and the Cardinal Health kit correction, as the kits are affected through the BD infusion set recall.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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