Use cautionMedical device recall · FDA · Published July 13, 2023
ICU Medical Plum 360 Infusion System Recall: Alarm Signal May Not Sound
ICU Medical recalls Plum 360 Infusion Systems with list numbers 300100405-300109913 manufactured July 2020-Dec 2021 due to potential alarm signal failure. Consumers should contact for details.
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Take action
Contact the company
📍Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835
“ICU Medical Plum 360 Infusion System Recall: Alarm Signal May Not Sound.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57667-icu-medical-plum-360-infusion-system-recall-alarm-signal-may. Based on FDA recall #Z-2430-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2430-2023%22&limit=1).
The FDA announced on July 13, 2023, that ICU Medical Inc. is recalling Plum 360 Infusion Systems due to a manufacturing defect that may prevent audible alarms from sounding. The recall affects approximately 93,135 devices distributed worldwide.
Manufacture dates: July 2020 through December 2021
The hazard
According to the FDA, a manufacturing defect in a supplier-provided component creates a potential that the audible signal for an alarm may not sound under certain conditions.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent similar recalls include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026) and the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026). Other recent recalls of similar products include the Philips IntelliVue MX40 Patient Monitor May Not Alarm recall (October 31, 2025), the Philips IntelliVue MX100 Patient Monitor Recall (October 31, 2025), and the Philips IntelliVue MX450 Patient Monitor Recall (October 31, 2025).
How to tell if you have this one
Check for list numbers starting with 300100405 through 300109913 on the pump. These units were manufactured between July 2020 and December 2021.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to ICU Medical for specific instructions on how to verify your pump model and get replacement or repair options.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2430-2023 (July 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2430-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.