ICU Medical is recalling approximately 423 Plum Duo Infusion Systems (List Number 40002-04-01) because a lot of primary speakers from a supplier was found to be defective. If this speaker fails, the pump will not produce audible alarms, alerts, or provide sound feedback when using the touchscreen. This could cause healthcare providers to miss critical pump status alerts or malfunctions. ICU Medical initiated this recall after discovering that the speakers may fail to produce sound entirely.
The failure of the primary speaker prevents the device from sounding alarms during critical medical events, which can lead to delayed treatment or unrecognized infusion issues. While visual alerts on the screen may still function, the lack of sound increases the risk of the failure going unnoticed by staff.
Quantity affected: 423 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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