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Use caution Medical device recall · FDA · Published April 20, 2018

CareFusion Alaris Infusion Pump Sets: Unable to Prime - Stop Using Now

CareFusion recalls Alaris infusion pump sets that users cannot prime. These sets may cause fluid flow issues. Stop using immediately to prevent potential complications.

🇺🇸 FDA recall #Z-0385-2019Medical deviceCareFusion ›
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Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

What happened, in plain English

CareFusion is recalling certain Alaris infusion pump administration sets that users report cannot be primed. This could lead to improper fluid delivery during medical treatments. Affected users should stop using these sets immediately. Read more at govinfonow.com/recall/71360-carefusion-alaris-infusion-pump-sets-unable-to-prime-stop-using.

Source Summary by GovInfoNow · govinfonow.com/recall/71360-carefusion-alaris-infusion-pump-sets-unable-to-prime-stop-using · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0385-2019

Cite this page

“CareFusion Alaris Infusion Pump Sets: Unable to Prime - Stop Using Now.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/71360-carefusion-alaris-infusion-pump-sets-unable-to-prime-stop-using. Based on FDA recall #Z-0385-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2019%22&limit=1).

Why it’s dangerous

The sets have a design flaw that prevents proper priming, which can cause fluid to flow uncontrollably. This may lead to incorrect medication delivery or fluid buildup in patients.

Who’s affected

Patients using these infusion sets for medical treatments, especially those with chronic conditions requiring regular infusions. Healthcare providers who administer these sets are most at risk.

How to tell if you have this one

Check the product label for model codes like 10011301, 10011462, or 24009-0007T. Lot numbers follow the format YYMMXXXX (e.g., 17011234) manufactured between January 2017 and March 2018.

  • Brand
    CareFusion
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the affected infusion sets as they cannot be primed properly.

  2. Check Product Label

    Look for model codes and lot numbers on the product label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: 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: “Worldwide Distribution - US Nationwide including Guam International: Canada, Australia, New Zealand, EU, Middel East, South Africa, Okinawa, Saipan, Buenos Aires, Lima, Selangor, Hong Kong, Taiwan, and Budapest” 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 terminated this recall 2.8 years after the firm started it.

1. Firm started the recall: Apr 20, 201812. FDA classified it Class II: Nov 3, 201823. Published in FDA’s Enforcement Report: Nov 14, 201834. FDA terminated the recall: Feb 10, 2021420182021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0385-2019 (April 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0385-2019 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.
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