ICU Medical recalled its Plum Solo and Duo Infusion pumps on December 15, 2025, after reports of programming errors. The pumps can fail to flush properly after piggyback therapy, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.
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 ICU Medical Plum Solo and Duo Infusion pumps are used in healthcare settings to deliver medications and fluids intravenously. They are essential for patients requiring precise dosing and continuous infusion of therapies, particularly in critical care environments.
The pumps can trigger a programming error that prevents the necessary flush after piggyback therapy. This malfunction may lead to dosing inaccuracies that could adversely affect patient health.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the affected pumps, which can disrupt treatment plans and affect patient safety.
The model number and software version are typically located on the device label or user manual.
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
Document all correspondence with the manufacturer, including dates, names, and details of conversations. Keep copies of any receipts or proof of purchase related to the device.
The affected models are ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US) and 400011001 (Philippines). These pumps were distributed worldwide. Specific software versions affected include 1.0.2 and 1.0.0.
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