FDA Alerts on Cardinal Health Presource Kits with Recalled BD Alaris Pump Infusion Sets
The US FDA has released an Early Alert regarding Cardinal Health Presource convenience kits that contain BD Alaris Pump Infusion Sets affected by an ongoing BD recall. BD's updated testing demonstrated that certain infusion sets with restrictive components, such as check valves, filters, and microbore tubing, perform worse than previously specified. Significant deviations in infusion accuracy and delayed occlusion alarm times occur primarily at infusion rates under 1 mL/h and bolus volumes of 5 mL or less. These performance failures can lead to undetected under- or over-infusion, posing substantial risks of severe harm or death in high-risk patients such as neonates, pediatric patients, and critically ill individuals receiving critical infusions like antiarrhythmics or vasopressors. While no serious injuries or deaths had been reported as of August 19, 2026, the FDA is highlighting Cardinal Health's updated instructions. Healthcare providers are advised to review inventory, consult BD's performance disclosures, and transition to alternative syringe pumps when clinically indicated, while applying operational mitigations such as avoiding container heights over 21 inches above the pump and keeping pressure mode settings at or below 50 mmHg for rates below 10 mL/h.
Key points
- Cardinal Health updated instructions for Presource convenience kits containing recalled BD Alaris Pump Infusion Sets.
- Testing revealed heightened flow inaccuracies and delayed occlusion alarms at rates below 1 mL/h and bolus volumes at or under 5 mL.
- Vulnerable populations such as neonates and critically ill patients receiving low-rate cardiovascular infusions face the greatest risk.
- Providers should use alternative syringe pumps where appropriate or adhere to strict setup mitigations if sets must be used.
What it means for you
Clinicians and hospital pharmacists in Pakistan should check their inventory to identify whether imported Cardinal Health Presource convenience kits or BD Alaris infusion sets are utilized in their facilities. For high-risk, low-rate infusions in pediatric or intensive care units, clinicians should consider alternative syringe pumps as recommended by the manufacturer. Healthcare facilities should monitor DRAP communications for any corresponding local alerts or supply directives.
Early Alert: 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.