Home / Recalls / Medical Devices
CareFusion 303, Inc. recalls BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Recalled August 13, 2025 · FDA recall Z-2179-2025 · CareFusion 303
Hazard
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. · FDA Class I
Units
33,162,680 units total
Sold at
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
Description
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.
Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Manufacturer(s)
CareFusion 303, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →