Reported Aug 13, 2025 · Ongoing
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
CareFusion 303, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Lot codes and dates
- BD Alaris" Pump Module
- Model 8100- All Serial Numbers/ UDI(s)
1088540322205410885403517723108854038100151088540381003910885403810046
- Amount recalled
- 33,162,680 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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