The Recall Desk
ModerateFDA (Devices)·Z-1118-2026·Announced 2026-01-28

Plum Duo infusion pumps recalled over blocked piggyback flush programming

ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record's stated consequence is that a flush cannot be programmed, with no patient harm or reported injury.

Plain-English summary

The ICU Medical Plum Duo Infusion Pump, list numbers 400020401 (US) on software versions 1.1.1, 1.1.2, 1.1.3 and 1.1.4, and 400021001 (Philippines) with software versions recorded in the enforcement record, is being recalled by ICU Medical, Inc.

The record states that Plum Solo and Duo infusion pumps include a feature that, when selected, automatically flushes the downstream line after a piggyback therapy, with the programmed flush volume delivered from the primary line container at the piggyback therapy rate once the piggyback therapy is complete. The record states that in certain cases the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) violation message when programming a piggyback flush, which prevents the flush from being programmed.

The record does not state a quantity. Distribution was worldwide, covering the United States nationwide and the Philippines. The FDA has classified the action as Class II.

The stated consequence in the enforcement record is that the flush cannot be programmed, and no injuries are reported. Facilities should follow ICU Medical's instructions.

The recalled product

Product
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion pump
Hazard

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 (6)

  • 400020401 (US)
  • Software Versions: 1.1.1
  • 1.1.2
  • 1.1.3
  • 1.1.4 400021001 (Philippines)
  • Software Versions: 1.1.0

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · software fault

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