Use caution Medical device recall · FDA · Published April 13, 2018

CareFusion Alaris Pump Model 8100: Bezel Plastic Weakening Risk

CareFusion recalls Alaris Pump Model 8100 units with FR-110 plastic bezels made between April 2011 and June 2017 due to potential weakening that could cause infusion errors.

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

🇺🇸 FDA recall #Z-1768-2019Medical device CareFusion ›

Use caution until it’s fixed

The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of 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 Alaris Pump Model 8100 devices with bezels made using FR-110 plastic resin from April 2011 to June 2017. Weakened plastic could cause the bezel to separate, leading to infusion errors like over or under delivery of medication. Read more at govinfonow.com/recall/71398-carefusion-alaris-pump-model-8100-bezel-plastic-weakening-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71398-carefusion-alaris-pump-model-8100-bezel-plastic-weakening-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1768-2019

Cite this page

“CareFusion Alaris Pump Model 8100: Bezel Plastic Weakening Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71398-carefusion-alaris-pump-model-8100-bezel-plastic-weakening-risk. Based on FDA recall #Z-1768-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1768-2019%22&limit=1).

The FDA announced on April 13, 2018, that CareFusion 303, Inc. is recalling Alaris Pumps, Model 8100, with bezel mechanical assemblies made of FR-110 plastic resin due to a potential weakening of the plastic. The agency classified this as a Class I recall affecting approximately 607,618 units distributed worldwide.

How to tell if you have it

Brand: CareFusion
Product: Alaris Pump, Model 8100
Component: Bezel mechanical assemblies manufactured with FR-110 plastic resin
Manufacture Date: April 2011 through June 2017
Affected Parts: LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203); Bezel Kit Assembly (P/N 10964559 and P/N 49000204)
Quantity: 607,618 units

The hazard

According to the FDA, the manufacturing process for the FR-110 plastic may have weakened the bezel, leading to separation of bezel posts or external cracking over time. This damage can result in free flow, over infusion, under infusion, or interruption of infusion.

Context

GovInfoNow's records show that CareFusion 303, Inc. has had 64 other recalls on record since June 12, 2017. Recent brand recalls include a BD Pyxis Mini Main REF 349 Medication Cabinet recall announced on April 30, 2026, due to a fingerprint scanner overheating risk, and a CareFusion recall from February 11, 2026, regarding unclear Transport Layer Security labeling. Other recent recalls of similar products include a BD Alaris Pump Infusion Sets Recall announced on August 19, 2026, for performance data discrepancies that may cause inappropriate pump function.

How to tell if you have this one

Check if your Alaris Pump Model 8100 was manufactured between April 2011 and June 2017 with bezel assemblies made using FR-110 plastic resin. Look for specific pump assembly part numbers: 10942012, 49000007, 49000203, 10964559, or 49000204.

Brand
CareFusion
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pump Model
Verify your Alaris Pump Model 8100 was manufactured between April 2011 and June 2017 with bezel assemblies using FR-110 plastic resin.
Contact CareFusion
Reach out to CareFusion for specific replacement or repair options for affected pumps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

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

Named in the notice: 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 5.7 years after the firm started it.

Apr 13, 2018Firm started the recall
Jul 16, 2019FDA classified it Class I
Jul 24, 2019Published in FDA’s Enforcement Report
Dec 26, 2023FDA 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/71398-carefusion-alaris-pump-model-8100-bezel-plastic-weakening-risk">CareFusion Alaris Pump Model 8100: Bezel Plastic Weakening Risk (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-1768-2019 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1768-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.