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# BD Recalls Alaris Pump Due to Infusion Sets
- URL: https://www.fdaweb.com/bd-recalls-alaris-pump-due-to-infusion-sets/
- Published: 2025-07-15T12:00:00.000Z
- Updated: 2026-09-14T15:16:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159509

BD and subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter about performance issues, under certain use cases, for the BD Alaris Pump Module model 8100 when used with a subset of compatible pump infusion sets. “BD stated that they have identified a subset of compatible pump infusion sets that may perform outside the performance ranges published in the user manuals for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume (POBV),” an agency [safety alert ](https://links-2.govdelivery.com/CL0/https:%2F%2Fwww.fda.gov%2Fmedical-devices%2Fmedical-device-recalls%2Fearly-alert-infusion-set-performance-issue-bd%3Futm%5Fmedium=email%26utm%5Fsource=govdelivery/1/010101980f2eabc9-50b089b0-885a-4fde-a044-d6b90f7e0366-000000/97NkI0sDVn-r%5FJahlf-kBvsVff8F7Dfq3o4dzaDPeMc=414?ref=fdaweb.com)says.

The deviations in performance from earlier published ranges are attributable to these pump infusion sets’ design features, such as filters and other in-line components, FDA says. “Filters with very fine pores (i.e., 0.2 micron) and other in-line components (i.e., back check valves and Y-sites) may impact performance such as flow rate accuracy and time to alarm, particularly at very low flow rates,” it adds.

The BD Alaris pump is described as a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, or irrigation of fluid spaces, according to FDA.