ICU Medical recalled the Plum Duo Infusion Pump on December 15, 2025, after reports of malfunctioning flush programming. The recall affects models 400020401 and 400021001 sold worldwide. This issue may pose a high risk to patient safety.
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, 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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves ICU Medical's Plum Duo Infusion Pump, List Numbers: 400020401 (US) and 400021001 (Philippines). The affected software versions include 1.1.0, 1.1.1, 1.1.2, 1.1.3, and 1.1.4. These devices were distributed worldwide.
The infusion pump includes a feature that flushes the downstream line after piggyback therapy. In certain cases, clinicians may receive Upper Hard Limit or Lower Hard Limit Violation messages, preventing the flush from being programmed. This malfunction could lead to improper medication administration.
There have been no specific injury or death reports associated with this recall. However, the potential for adverse events exists due to the malfunction.
Stop using the infusion pump immediately. Contact ICU Medical or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, contact ICU Medical at [contact number]. Visit the manufacturer’s website for detailed recall instructions.
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