ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer 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 recall includes Plum Duo Precision IV Pumps, List Numbers: 400020403 (US), 400021003 (Philippines). The affected software versions are 1.2.2 and 1.2.0. The device has been distributed worldwide.
The IV pumps may not properly program flush volumes, leading to potential medication delivery issues. This malfunction can cause Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation messages.
Currently, there are no reported injuries or deaths associated with this recall. The potential for improper medication delivery poses a high risk to patients.
Stop using the device immediately. Contact ICU Medical for further instructions. Follow the recall instructions provided in the notification letter.
For more information, contact ICU Medical, Inc. at their official website or through the notification letter.
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