ICU Medical Plum 360 Infusion System Recall: Connectivity Module May Disengage
ICU Medical recalls Plum 360 Infusion System Model 30010 due to risk of connectivity module disengaging, causing shutdown without alarm. Affected units may delay therapy or interrupt infusions.
Use caution until it’s fixed
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Contact the company
What happened, in plain English
ICU Medical is recalling its Plum 360 Infusion System (Model 30010) because the Connectivity Engine Module can disengage from the main chassis, causing the unit to shut down without warning. This could delay or interrupt critical therapy or infusions. Read more at govinfonow.com/recall/73862-icu-medical-plum-360-infusion-system-recall-connectivity-module-may.
Source Summary by GovInfoNow · govinfonow.com/recall/73862-icu-medical-plum-360-infusion-system-recall-connectivity-module-may · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3031-2017
Cite this page
“ICU Medical Plum 360 Infusion System Recall: Connectivity Module May Disengage.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73862-icu-medical-plum-360-infusion-system-recall-connectivity-module-may. Based on FDA recall #Z-3031-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3031-2017%22&limit=1).
Why it’s dangerous
The Connectivity Engine Module may detach from the main chassis during use, causing the unit to shut down without alerting the user. This could interrupt critical therapy or infusions if the patient requires continuous treatment.
Who’s affected
Patients using the Plum 360 Infusion System Model 30010 for medical therapy are affected. Healthcare providers and patients receiving infusion treatments are most at risk.
How to tell if you have this one
Check for the Plum 360 Infusion System with model number 30010. This product was sold by ICU Medical, Inc. for medical use.
- Brand
ICU Medical- Category
Medical device
What to do — step by step
Check for Disengagement
Inspect the Connectivity Engine Module to ensure it remains securely attached to the main chassis.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-3031-2017 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3031-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.