FDA-Device2025-08-13Class I
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
CareFusion 303, Inc.
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.
Sold states
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
Affected count
33,162,680 units total
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2025Don't want to check this manually?
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