FDA Labels Cardinal Health Presource Kits with BD Alaris Sets a Class I Correction
The US Food and Drug Administration has classified a correction by Cardinal Health involving certain Presource convenience kits as a Class I recall, its most serious category. The affected procedure kits contain BD Alaris Pump Infusion Sets with restrictive components such as filters, check valves, and microbore tubing that may perform worse than previously specified. The correction does not remove the kits from service but requires healthcare providers to follow revised use instructions to avoid serious injury or death.
Testing by manufacturer BD revealed that previously claimed delivery performance was overestimated. Inaccuracies in rate and bolus volume are most pronounced at low infusion rates below 1 mL/h and bolus volumes of 5 mL or less. These performance issues may cause delayed occlusion alarms, under-infusion, or over-infusion. Vulnerable patient populations, including neonates, paediatric patients, and critically ill individuals receiving low-rate infusions of high-alert medications such as antiarrhythmics or vasopressors, face the highest risk of harm.
The agency advises facilities to identify affected kits and evaluate whether the infusion sets remain clinically appropriate. BD recommends switching to a syringe pump if low-rate accuracy is critical. If alternatives are not available, clinicians may continue using the affected sets with caution, heightened clinical monitoring, and strict adherence to specific operational precautions, including maintaining correct solution bag height, proper pressure settings, and shutting off flow to the patient prior to clearing occlusions.
Key points
- Cardinal Health is issuing updated instructions for Presource convenience packs containing specific BD Alaris Pump Infusion Sets without removing them from facilities.
- Infusion sets with restrictive components show reduced flow accuracy, particularly at programmable rates below 1 mL/h and boluses of 5 mL or under.
- Inaccuracies may cause under- or over-infusion and delayed occlusion alarms, posing severe risks for neonates, children, and critically ill patients.
- Clinicians are advised to switch to syringe pumps where appropriate or implement rigorous risk mitigations and enhanced monitoring if alternative pumps are unavailable.
What it means for you
Clinicians and biomedical engineers in Pakistan should check hospital inventories for imported Cardinal Health Presource kits or BD Alaris infusion sets and verify local regulatory alerts through DRAP. When using these infusion systems for critically ill or paediatric patients requiring low infusion rates, teams should consider syringe pumps or adhere strictly to the updated operational warnings and pressure monitoring guidelines.
Convenience Kit Correction: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.