Unrated Medical device recall · FDA · Published October 30, 2017

ICU Mednet Medication Management Suite 6.1/6.21: Risk of Incorrect Medication Settings

ICU Medical recalls Medication Management Suite 6.1 and 6.21 software due to potential changes to piggyback medication settings without user notice, which could affect infusion safety.

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

🇺🇸 FDA recall #Z-0195-2018Medical device ICU Medical ›

Recall notice

Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.

Take action

Contact the company

Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835

✎ GovInfoNow plain-language explainer

ICU Medical is recalling its Medication Management Suite software versions 6.1 and 6.21 because it can alter medication settings without warning. This could lead to incorrect infusion programming, potentially causing medication errors in clinical settings. Read more at govinfonow.com/recall/72645-icu-mednet-medication-management-suite-6-1-6-21-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72645-icu-mednet-medication-management-suite-6-1-6-21-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0195-2018

Cite this page

“ICU Mednet Medication Management Suite 6.1/6.21: Risk of Incorrect Medication Settings.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72645-icu-mednet-medication-management-suite-6-1-6-21-risk. Based on FDA recall #Z-0195-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0195-2018%22&limit=1).

The FDA announced on 2017-10-30 that ICU Medical, Inc. is recalling its ICU Mednet(TM) Medication Management Suite versions 6.1 and 6.21. The software may alter piggyback medication entry settings without notice to users or clinicians.

How to tell if you have it

ICU Mednet(TM) Medication Management Suite 6.1, Product Code/List Numbers: 16037-64-01; 16037-64-02; 16037-64-03
ICU Mednet(TM) Medication Management Suite 6.21, Product Code/List Number: 16037-64-04

The hazard

Under certain conditions, the programs can change whether a medication may be piggybacked or if an infusion may be interrupted by a piggyback. These changes occur when exporting and importing drug libraries with specific entry configurations. The altered settings are finalized and downloaded to infusers without any notice provided to the user or clinician.

Context

GovInfoNow's records show ICU Medical, Inc. has had 60 other recalls on record since 2017-06-15. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2025-11-14), Medtronic SynchroMed Flex Infusion Software Issue (2026-04-08), and Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25).

How to tell if you have this one

Check if you have ICU Mednet Medication Management Suite 6.1 or 6.21 software with product codes 16037-64-01 through 16037-64-04. The software is used in clinical settings for managing infusion pumps.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your software version by checking the product code on the device or documentation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines” 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.

Oct 30, 2017Firm started the recall
Dec 6, 2017FDA classified it Class II
Dec 13, 2017Published in FDA’s Enforcement Report
Sep 3, 2020FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall describes potential changes to medication settings, but does not explicitly state a risk of serious injury.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/72645-icu-mednet-medication-management-suite-6-1-6-21-risk">ICU Mednet Medication Management Suite 6.1/6.21: Risk of Incorrect Medication Settings (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-0195-2018 (October 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0195-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.