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# CDRH Expands Recall of BD Alaris Pump Infusion Sets
- URL: https://www.fdaweb.com/cdrh-expands-recall-of-bd-alaris-pump-infusion-sets/
- Published: 2025-09-29T12:00:00.000Z
- Updated: 2026-09-14T15:22:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159948

FDA has issued an [updated alert](https://www.fda.gov/medical-devices/medical-device-recalls/update-alert-infusion-set-performance-issue-bd?ref=fdaweb.com) about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets, warning that continued use of the affected devices could cause serious injury or death. The recall involves performance issues with the BD Alaris Pump Module model 8100 when used with specific compatible infusion sets. BD and its subsidiary CareFusion have already issued two “Urgent Medical Device Recall (Correction)” letters to customers, with the most recent communication expanding the list of affected devices, corrective actions, and risk information.

The agency says that updates to the recall include additional infusion set models now affected, revised recommendations for clinical use, and expanded mitigation measures. BD has urged healthcare facilities to:

- Use alternate BD Alaris Pump infusion sets where clinically appropriate, prioritizing availability for critical-care, neonatal, infant, and pediatric settings.
- If no suitable alternatives are available, consider switching to the BD Alaris Syringe Module or another syringe pump.
- In situations where no alternatives exist, use the recalled sets with heightened caution and enhanced clinical monitoring, following specific risk mitigation steps outlined in the Alaris Infusion System User Manual.