Use caution Medical device recall · FDA · Published September 11, 2025

BD Alaris Pump Infusion Sets May Cause Flow Rate Errors - Recall

CareFusion recalls BD Alaris Pump Infusion Sets with specific reference numbers due to potential flow rate and bolus accuracy issues that could affect patient safety.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0035-2026Medical device BD Alaris ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386

✎ GovInfoNow plain-language explainer

CareFusion is recalling BD Alaris Pump Infusion Sets with certain reference numbers because they may not function correctly, potentially causing incorrect medication delivery. This could lead to unsafe treatment outcomes for patients using these devices. Read more at govinfonow.com/recall/51325-bd-alaris-pump-infusion-sets-may-cause-flow-rate-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/51325-bd-alaris-pump-infusion-sets-may-cause-flow-rate-errors · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0035-2026

Cite this page

“BD Alaris Pump Infusion Sets May Cause Flow Rate Errors - Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51325-bd-alaris-pump-infusion-sets-may-cause-flow-rate-errors. Based on FDA recall #Z-0035-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0035-2026%22&limit=1).

The FDA announced on Sept. 11, 2025, that CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets because the pump module may perform outside established performance ranges for flow rate and accuracy. Owners should contact the company for a remedy.

How to tell if you have it

Brand: BD Alaris
Product: Pump Infusion Sets
Reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron; SmartSite Y-Site 10015414; 180 Micron Filter 2447-0007; Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007; 2 SmartSite Y-sites 10012645; Back Check Valve, Non-vented, SmartSite Y-site 2426-0500; Back Check Valve, 3 SmartSite Y-sites 2450-0500; Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558; Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500; 2 SmartSite Y-Sites 2232-0007; 0.2 Micron Filter 11613191; 0.2 Micron Filter, Ball Valve, SmartSite Port (Burette), 2 SmartSite Y-sites 10012144; 3 SmartSite Y-Sites, Check Valve 10013034; 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037; Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773; 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
Lots/UDIs: 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: US Nationwide; United Arab Emirates, Australia, Belgium, Bahrain, Botswana, Canada, Switzerland, China, France, United Kingdom, Gibraltar, Israel, India, Kuwait, Mexico, Malaysia, Netherlands, New Zealand, Philippines, Pakistan, Qatar, Saudi Arabia, Singapore, Taiwan, Province of China, South Africa

The hazard

The 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.

Context

GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. Other recent recalls of similar products include BD Alaris Pump Infusion Sets Recall: Performance Data Discrepancies May Cause Inappropriate Pump Function (2026-08-19), B Braun Blood Administration Sets Recall: Risk of Medication Backflow (2025-10-29) and B Braun ADDitIV IV Sets Recall: Risk of Medication Backflow (2025-10-29).

How to tell if you have this one

Check the reference numbers on the packaging: C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 11522558, 2410-0500, 2232-0007, 11613191, 10012144, 10013034, 10013037, 11582773. These sets were sold with specific lot numbers and UDI codes.

Brand
BD Alaris
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the reference numbers and lot codes on the packaging to confirm if your set is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

Sep 11, 2025Firm started the recall
Oct 8, 2025FDA classified it Class I
Oct 15, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51325-bd-alaris-pump-infusion-sets-may-cause-flow-rate-errors">BD Alaris Pump Infusion Sets May Cause Flow Rate Errors - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0035-2026 (September 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0035-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.