Use caution Medical device recall · FDA · Published June 30, 2020

CareFusion Alaris Pump Module Model 8100 Recall: Broken Elements Risk Inaccurate Fluid

CareFusion recalls Alaris Pump Module Model 8100 with all serial numbers due to broken elements that may cause inaccurate fluid delivery, over or under infusion risks.

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

🇺🇸 FDA recall #Z-2736-2020Medical device CareFusion ›

Use caution until it’s fixed

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

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 all Alaris Pump Module Model 8100 devices because broken elements can cause inaccurate fluid delivery, potentially leading to over or under infusion of fluids. This could affect patients using the device for medical purposes. Read more at govinfonow.com/recall/64878-carefusion-alaris-pump-module-model-8100-recall-broken-elements-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64878-carefusion-alaris-pump-module-model-8100-recall-broken-elements-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2736-2020

Cite this page

“CareFusion Alaris Pump Module Model 8100 Recall: Broken Elements Risk Inaccurate Fluid.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64878-carefusion-alaris-pump-module-model-8100-recall-broken-elements-risk. Based on FDA recall #Z-2736-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2736-2020%22&limit=1).

CareFusion 303, Inc. is recalling the Alaris Pump Module Model 8100 due to broken platen elements that may cause inaccurate fluid delivery, according to the FDA on June 30, 2020.

How to tell if you have it

Brand: CareFusion
Product: Alaris Pump Module Model 8100
Serial numbers: All serial numbers

The hazard

Broken elements on the pump module platen, such as the upper hinge post or lower hinge, can occur if the door is forcefully closed, the device is dropped, or improper cleaners are used. These defects may prevent devices from delivering accurate amounts of fluid, resulting in over infusion, free-flow conditions, or under infusion.

Context

GovInfoNow's records show CareFusion 303, Inc. has had 64 other recalls on record since June 12, 2017. Other recent recalls of similar products include BD Alaris Pump Infusion Sets Recall (August 19, 2026), MiniMed Flex Insulin Pump Recall (August 20, 2026), and ICU Medical Plum Duo Infusion Pump Recall (April 29, 2026).

How to tell if you have this one

Check for the Alaris Pump Module Model 8100 with any serial number. This device is used for medical fluid delivery systems.

Brand
CareFusion
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Condition
Inspect for broken elements such as hinges or membranes that could cause inaccurate fluid delivery.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C. and Puerto Rico.

FDA distribution: “US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU,…” 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, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Jun 30, 2020Firm started the recall
Aug 6, 2020FDA classified it Class I
Aug 12, 2020Published in FDA’s Enforcement Report
Apr 23, 2024FDA terminated the recall

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/64878-carefusion-alaris-pump-module-model-8100-recall-broken-elements-risk">CareFusion Alaris Pump Module Model 8100 Recall: Broken Elements Risk Inaccurate Fluid (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-2736-2020 (June 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2736-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.