Official recall notice

FDA DeviceClass IINotable

FDA Recall: Plum Duo Infusion Pump, 40002-0401

Recall date
2026-06-17
FDA class
Class II

Why it was recalled

Hazard

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Recommended action

What to do

13,613

Product description

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

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