CareFusion 303, Inc. recalls BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Recall date

July 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2179-2025

FDA classification

Class I

Brand / firm

CareFusion 303, Inc.

Sold / distributed

US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey

Why it was recalled

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions