The Recall Desk
HighFDA (Devices)·Z-1991-2025·Announced 2025-06-25

ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a risk-of-harm defect where the potential exists for patient harm through medication overdose, but no illnesses or injuries have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling the Plum Solos infusion pump (Item number 400011001) due to an internal testing finding that a workflow in software version 1.1.1 may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or body surface area (BSA) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

A total of 214 units have been distributed across the US in the states of Florida, Kentucky, Virginia, Mississippi, Massachusetts, Pennsylvania, New York, California, and Iowa, as well as in the Philippines. The affected units are identified by specific serial/lot numbers beginning with 60000001 through 60000300 (with gaps in the sequence).

Patients and healthcare providers who have these pumps should contact ICU Medical immediately to discuss the appropriate action. The FDA classified this as a Class II recall.

The recalled product

Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
214

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI/DI N/A
  • Serial/Lot Numbers: 60000001
  • 60000002
  • 60000003
  • 60000005
  • 60000006
  • 60000007
  • 60000008
  • 60000009
  • 60000010
  • 60000011
  • 60000014
  • 60000015
  • 60000016
  • 60000017
  • 60000019
  • 60000020
  • 60000021
  • 60000023
  • 60000024

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · overdose risk

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