Agency classClass IOur severity:Critical FDA (Devices)·Z-0035-2026·Announced 2025-10-15

Infusion pump sets recalled over flow rate and occlusion alarm accuracy

CareFusion is recalling BD Alaris Pump Infusion Sets because the pump module used with them may perform outside established ranges for flow rate, bolus accuracy and occlusion alarm timing.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

BD Alaris Pump Infusion Sets are being recalled across reference numbers including C24101E (amber tubing, 15 micron filter, 0.2 micron filter, SmartSite Y-Site), 10015414 (180 micron filter), 2447-0007 (ball valve SmartSite port burette with two SmartSite Y-Sites) and others.

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

The recall covers all lots. Distribution was nationwide in the United States and internationally to countries including the United Arab Emirates, Australia, Belgium, Bahrain, Botswana, Canada, Switzerland, China and France. The FDA has classified the recall as Class I.

Hospitals using these sets should follow BD's instructions, since the affected parameters govern how much fluid a patient receives and how quickly a blockage is detected.

The recalled product

Product: BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites…
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Infusion set
Hazard: flow-rate-accuracy
occlusion-alarm
dosing-error
infusion-pump

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

All Lots/ UDI: C24101E - 10885403235528
10015414 - 10885403233999
2447-0007 - 10885403235078
24201-0007 - 10885403476341
10012645 - 10885403233753
2426-0500 - 7613203020992
11522558 - 10885403232305
2410-0500 - 7613203012492
2232-0007 - 10885403463969
11613191 - 10885403276026
10012144 - 7613203021159
10013034 - 10885403232312
10013037 - 10885403233784
11582773 - 10885403239588

Distribution

Distributed nationwide across the United States.

Same manufacturer · CareFusion 303, Inc.

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