ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
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 recalled product is the Plum Duo Infusion System, List Number 40002-04-01. It was distributed worldwide, including across the U.S. The specific model numbers include UDI-DI: M335400021, with serial numbers ranging from 50000221 to 50001830.
The primary speaker in the infusion pump may fail, resulting in a lack of audible alarms and alerts. This defect can prevent essential notifications for medication administration, increasing the risk of patient harm.
ICU Medical has not reported any incidents or injuries related to this defect yet. However, the potential for serious consequences exists if the device fails to alert healthcare providers.
Stop using the Plum Duo Infusion System immediately. Contact ICU Medical or your healthcare provider for further instructions on the recall.
For more information, contact ICU Medical, Inc. at their official website. Additional resources can be found on the FDA's recall page.
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