Class I Recall Issued for BD Alaris Pump Infusion Sets Due to Performance Risks
BD and CareFusion have issued an updated Class I recall regarding certain BD Alaris Pump Infusion Sets compatible with the BD Alaris Pump Module model 8100. Testing revealed that certain sets with restrictive components perform significantly worse than previously disclosed, particularly at low infusion rates, which can lead to under- or over-infusion, delayed alarms, and bolus inaccuracies.
The manufacturer advises users to immediately identify and discard discontinued infusion sets and switch to clinically appropriate alternatives. Where supplies are limited, alternative sets should be prioritized for critical care, neonatal, infant, and pediatric care areas.
Key points
- Affected products include specific BD Alaris Pump Infusion Sets used with the BD Alaris Pump Module model 8100.
- Performance deviations commonly occur at low programmable rates under 1 mL/h and small bolus volumes.
- Issues can lead to undetected under- or-over infusion, delayed occlusion alarms, and inaccurate bolus doses.
- Discontinued sets should be discarded and replaced with appropriate alternatives or alternative syringe pumps.
What it means for you
Clinicians and pharmacists should review their facility inventory for discontinued BD Alaris Pump Infusion Sets and ensure high-risk areas are prioritized for safe alternative sets or pumps. Please check with the Drug Regulatory Authority of Pakistan (DRAP) for local product availability and specific regulatory guidance.
Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.