Use cautionMedical device recall · FDA · Published October 30, 2017
ICU Medical Plum 360 Infusion System Recall: Malfunction Risks
ICU Medical recalls Plum 360 Infusion Systems with software v15.10.00.010 due to potential pump lockout during alarms and unresponsive device after 1,500 hours of use.
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
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 Plum 360 Infusion Systems with software version 15.10.00.010 because they can malfunction when alarms occur while paused or become unresponsive after 1,500 hours of use. This could prevent safe delivery of medication if the pump locks up. Read more at govinfonow.com/recall/72646-icu-medical-plum-360-infusion-system-recall-malfunction-risks.
“ICU Medical Plum 360 Infusion System Recall: Malfunction Risks.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72646-icu-medical-plum-360-infusion-system-recall-malfunction-risks. Based on FDA recall #Z-0101-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2018%22&limit=1).
ICU Medical, Inc. recalled the Plum 360 Infusion System nationwide and to Canada and Australia on Oct. 30, 2017, according to the FDA. The devices may malfunction, preventing users from turning off the pump or interacting with the device under specific conditions.
How to tell if you have it
Brand: ICU Medical
Product: Plum 360 Infusion System
List number: 30010
Software version: v15.10.00.010
Quantity: 21,461 devices
The hazard
The FDA said the pump cannot be turned off or restarted if a malfunction alarm occurs while in the "Paused" state waiting for distal pressure to decrease. Additionally, users cannot interact with the device when accessing the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time greater than 1,500 hours.
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 (Aug. 20, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026).
How to tell if you have this one
Check for software version 15.10.00.010 on the Plum 360 Infusion System. This recall applies to all devices with this specific software version.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Plum 360 Infusion System to confirm if it is 15.10.00.010.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.” 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 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0101-2018 (October 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0101-2018 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.