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Recall Observatory FDA recall evidence

Device product

Plum Duo Precision IV Pump, 40002-0403

Z-2313-2026

April 29, 2026

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 98872
Status
Ongoing
Classification
Class II
Quantity
13,613
Official record key
device-enforcement:Z-2313-2026

Official wording

Reason: 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.

Code information: UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3

Distribution pattern: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.