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Use caution Medical device recall · FDA · Published August 4, 2020

CareFusion Alaris System PC Unit Model 8015 Recall: Unresponsive Keypads Risk Infusion

CareFusion recalls Alaris System PC Unit Model 8015 (serials from April 7, 2017) due to unresponsive keypad keys that may cause infusion delays or interruptions, risking serious injury or death for high-risk patients.

🇺🇸 FDA recall #Z-2909-2020Medical deviceCareFusion ›
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Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

CareFusion is recalling Alaris System PC Unit Model 8015 pumps because unresponsive keys can cause infusion delays or interruptions. For patients on life-sustaining infusions, this could lead to serious injury or death. Read more at govinfonow.com/recall/64529-carefusion-alaris-system-pc-unit-model-8015-recall-unresponsive-keypads.

Source Summary by GovInfoNow · govinfonow.com/recall/64529-carefusion-alaris-system-pc-unit-model-8015-recall-unresponsive-keypads · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2909-2020

Cite this page

“CareFusion Alaris System PC Unit Model 8015 Recall: Unresponsive Keypads Risk Infusion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64529-carefusion-alaris-system-pc-unit-model-8015-recall-unresponsive-keypads. Based on FDA recall #Z-2909-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2909-2020%22&limit=1).

CareFusion 303, Inc. recalled the Alaris System PC Unit Model 8015 on Aug. 4, 2020, according to the FDA. The pump module keypad may exhibit unresponsive or stuck keys due to fluid ingress, potentially causing infusion delays or interruptions that can result in serious injury or death.

How to tell if you have it

  • Brand: CareFusion
  • Product: Alaris System PC Unit Model 8015
  • Serial numbers manufactured from April 07, 2017 to Present

The hazard

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

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 Pyxis MedStation ES Tower 352 Medication Cabinet Recall (2026-04-30), CareFusion 303, Inc. - CareFusion (2026-02-11), and BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03). Other recent recalls of similar products include BD Alaris Pump Infusion Sets Recall (2026-08-19), Baxter Novum IQ Syringe Pump Recall (2026-08-11), and Fresenius Kabi Ivenix Infusion Pump Recall (2025-11-03).

How to tell if you have this one

Check for the Alaris System PC Unit Model 8015 with serial numbers from April 7, 2017 onward. This model is used in medical infusion systems.

  • Brand
    CareFusion
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
Recall numberProduct, codes & lotsQuantity
Z-2909-2020Alaris System PC Unit Model 8015; All serial numbers manufactured from April 07, 2017 to Present.313740
Z-2910-2020PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2; All kits manufactured from April 07, 2017 to Present.28346
Based on the official FDA remedy

What to do — step by step

  1. Check Keypad Responsiveness

    Test the keypad for unresponsive or stuck keys that could delay or interrupt infusions.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C..

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE,…” 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Aug 4, 202012. FDA classified it Class I: Sep 4, 202023. Published in FDA’s Enforcement Report: Sep 16, 202032020
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

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

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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-2909-2020 (August 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2909-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA