FDA Issues Alert on Cardinal Health Presource Kits Containing Recalled BD Alaris Infusion Sets
The US Food and Drug Administration has issued an early alert regarding a medical device correction initiated by Cardinal Health for its Presource convenience kits. These kits may include BD Alaris Pump Infusion Sets that are subject to a previously announced recall by BD and CareFusion.
The affected infusion sets can malfunction, resulting in unpredictable pump operation such as under-infusion, over-infusion, or a complete failure to deliver medication. Such errors may cause severe adverse clinical events, particularly in vulnerable populations including neonates, pediatric patients, and critically ill individuals. As of August 19, 2026, no serious injuries or deaths have been reported in connection with this issue.
Cardinal Health advises healthcare facilities to locate and quarantine affected Presource kits. Facilities must affix a clear warning label to the front of each kit instructing clinical staff to remove and discard the recalled BD Alaris infusion set components before using the rest of the kit.
Key points
- Cardinal Health is correcting Presource convenience kits that package recalled BD Alaris Pump Infusion Sets.
- Defective infusion sets can cause under-infusion, over-infusion, or failure to infuse, creating high risks for neonates, pediatric, and critically ill patients.
- Facilities must quarantine affected kits and attach prominent warning labels instructing staff to discard the recalled infusion sets before kit use.
- No serious injuries or deaths had been reported by BD as of August 19, 2026.
What it means for you
Healthcare providers and biomedical engineering teams in Pakistan should review procedural convenience packs and inventory to verify whether any imported Cardinal Health Presource kits containing BD Alaris sets are in use. If found, clinicians must ensure the recalled infusion sets are discarded prior to procedure use to avoid potentially severe dosing errors, and check DRAP for relevant local alerts and device guidance.
Early Alert: Cardinal Health Issues Correction 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.