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 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.
The IV pumps may display an Upper Hard Limit or Lower Hard Limit violation message, preventing the flush from being programmed post-therapy. This malfunction could lead to inadequate medication delivery, posing significant health risks.
Stop using the affected pumps immediately. Contact ICU Medical, Inc. or a healthcare provider for further instructions. Follow the recall instructions provided via letter.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1120-2026.
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