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Use caution Medical device recall · FDA · Published August 1, 2018

ICU Medical Plum 360 Infusion System Recall: Software Glitch Causes Blank Screen

ICU Medical recalls Plum 360 Infusion Systems with specific software versions when used with MedNet Custom Drug Libraries, which can become inoperable and show a blank screen.

🇺🇸 FDA recall #Z-0171-2020Medical deviceICU Medical ›
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Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835
✎ GovInfoNow plain-language explainer

ICU Medical is recalling certain Plum 360 Infusion Systems that may become inoperable and show a blank screen when used with specific MedNet Custom Drug Libraries. This could lead to medication delivery issues during critical medical procedures. Read more at govinfonow.com/recall/70229-icu-medical-plum-360-infusion-system-recall-software-glitch-causes.

Source Summary by GovInfoNow · govinfonow.com/recall/70229-icu-medical-plum-360-infusion-system-recall-software-glitch-causes · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0171-2020

Cite this page

“ICU Medical Plum 360 Infusion System Recall: Software Glitch Causes Blank Screen.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70229-icu-medical-plum-360-infusion-system-recall-software-glitch-causes. Based on FDA recall #Z-0171-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0171-2020%22&limit=1).

The FDA announced on August 1, 2018, that ICU Medical Inc. is recalling Plum 360 Infusion Systems due to a software malfunction hazard. The defect can cause the device to become inoperable with a blank screen when used with specific drug libraries.

How to tell if you have it

  • Brand: ICU Medical
  • Product: Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module
  • Model #: 30010
  • Software versions: 15.10.00.010, .011, .012 and 15.11.00.017

The hazard

A software malfunction occurs when the infuser is used with a MedNet Custom Drug Library (CDL). Downloading and installing a new CDL can cause the infuser to become inoperable and display a blank screen on the User Interface.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and 60004087 recall (June 10, 2026).

How to tell if you have this one

Check for the model number 30010 on the Plum 360 Infusion System. The affected units have software versions 15.10.00.010/.011/.012 or 15.11.00.017 when used with ICU Medical MedNet Custom Drug Libraries.

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

What to do — step by step

  1. Check Software Version

    Verify the software version on your Plum 360 Infusion System to see if it matches the affected versions listed in the recall.

  2. Contact Healthcare Provider

    Reach out to your healthcare facility to determine if your system is affected and to get guidance on next steps.

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: “US nationwide distribution, and Canada” 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 2.7 years after the firm started it.

1. Firm started the recall: Aug 1, 201812. FDA classified it Class II: Oct 22, 201923. Published in FDA’s Enforcement Report: Oct 30, 201934. FDA terminated the recall: Apr 27, 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-0171-2020 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0171-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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