The Recall Desk
SevereFDA (Devices)·Z-2129-2025·Announced 2025-08-13

Plum Duo Infusion System User Interface May Become Unresponsive

Approximately 4,677 Plum Duo Infusion Systems may experience user interface unresponsiveness due to programming events and alarm interactions. Users should contact ICU Medical for guidance on affected units.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification indicates serious hazard. Per recall guidelines, FDA Class I recalls have a minimum severity of 4. The affected device is a critical infusion pump; user interface unresponsiveness poses risk to proper device operation.

Plain-English summary

The Plum Duo Infusion System, List Number 400020401, manufactured by ICU Medical, Inc., is being recalled. Approximately 4,677 units were distributed nationwide in the United States.

ICU Medical has identified two specific sequences of programming events and alarm interactions that may cause the device's user interface to become unresponsive. A unresponsive user interface on a critical medical infusion device presents a patient safety risk.

Healthcare providers and individuals using affected units should contact ICU Medical for information regarding their specific devices and any recommended actions.

The recalled product

Product
Plum Duo Infusion System, List Number: 400020401
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Pump
Hazard
  • ui-unresponsiveness
  • software-error

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 (1)

  • UDI-DI: M335400021

Distribution

Distributed nationwide across the United States.

Related recalls

Same category