Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Plum 360 Infusion System Recalled by ICU Medical Inc Due to (1) Under certain conditions, if a malfunction alarm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical Inc directly.
Affected Products
Plum 360 Infusion System, List number 30010.
Quantity: 21,461 devices
Why Was This Recalled?
(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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ICU Medical Inc
ICU Medical Inc has 50 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report