FDA DeviceClass IINotable

FDA Recall: Plum Duo Precision IV Pump, 40002-0403

Date: 2026-06-17
Brand: ICU Medical, Inc.
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

13,613

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