CareFusion 303, Inc. — BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 8, 2025
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
What's affected?
- Product
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Brand
- CareFusion 303, Inc.
- Lot code
- BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
Additional details
BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 33,162,680 units total.
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