Use caution Medical device recall · FDA · Published January 23, 2025

CareFusion BD Alaris Pump Module 8100: Risk of Overinfusion from Open Safety Clamp

CareFusion recalls BD Alaris Pump Module REF 8100 due to user manual error that may cause accidental overinfusion if safety clamp is left open. Affected units include those with software version 12.1.2.

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

🇺🇸 FDA recall #Z-1231-2025Medical device CareFusion ›

Use caution until it’s fixed

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

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 Module REF 8100 because the user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets. This could lead to accidental overinfusion of fluids, which may cause injury. Read more at govinfonow.com/recall/53036-carefusion-bd-alaris-pump-module-8100-risk-of-overinfusion-from.

Source Summary by GovInfoNow · govinfonow.com/recall/53036-carefusion-bd-alaris-pump-module-8100-risk-of-overinfusion-from · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1231-2025

Cite this page

“CareFusion BD Alaris Pump Module 8100: Risk of Overinfusion from Open Safety Clamp.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53036-carefusion-bd-alaris-pump-module-8100-risk-of-overinfusion-from. Based on FDA recall #Z-1231-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1231-2025%22&limit=1).

CareFusion 303, Inc. recalled the BD Alaris Pump Module REF 8100 due to user manual errors that could cause accidental over-infusion, the FDA said on Jan. 23, 2025. The recall affects 242,098 systems distributed in the U.S., Canada, and Guantanamo Bay.

How to tell if you have it

Brand: CareFusion
Product: BD Alaris Pump Module REF 8100
Catalog Number: 8100
UDI-DI codes: 10885403810046, 10885403517723
Software Version: 12.1.2
Units affected: 242,098 systems

The hazard

The hazard stems from the User Manual incorrectly instructing users to leave the safety clamp open when reloading an infusion set. This error potentially could result in accidental over-infusion if the roller clamp is left open.

Context

GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. Recent brand recalls include a 2026-04-30 issue with the BD Pyxis MedBank Tower 1145-00 where the fingerprint scanner may overheat, and a 2026-02-11 recall regarding labeling for TLS versions on hospital networks. Other recent recalls of similar products include the 2026-08-19 BD Alaris Pump Infusion Sets Recall for performance data discrepancies, the 2025-10-29 B Braun CARESAFE IV Sets Recall for medication backflow risk, and the 2025-11-03 Fresenius Kabi Ivenix Infusion Pump Recall for downstream occlusion risk.

How to tell if you have this one

Check for the BD Alaris Pump Module REF 8100 with software version 12.1.2. The product is sold under CareFusion and used for continuous or intermittent fluid administration in medical settings.

Brand
CareFusion
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Safety Clamp Position
Ensure the safety clamp is fully closed before reloading an infusion set to prevent accidental overinfusion.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 41 days after the firm started it.

Jan 23, 2025Firm started the recall
Feb 24, 2025FDA classified it Class II
Mar 5, 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/53036-carefusion-bd-alaris-pump-module-8100-risk-of-overinfusion-from">CareFusion BD Alaris Pump Module 8100: Risk of Overinfusion from Open Safety Clamp (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-1231-2025 (January 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1231-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.