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Moderate riskFDA DeviceClass II

ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts

The Plum Duo Precision IV Pump may fail to display a soft limit alert under certain conditions, meaning clinicians won't be notified before the pump starts delivering medication that exceeds the set safety limit. This could result in patients receiving too much or too little medication.

From the FDA notice · Read the official notice ↗ · All ICU Medical recalls

What to do

  1. If you operate this pump (model 40002-0403, v1.2.3), contact ICU Medical for guidance or a firmware update.
  2. Review your facility's inventory and alert procedures for affected units.
  3. Monitor infusions more closely on affected pumps until you receive official corrective instructions from ICU Medical.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Plum Duo Precision IV Pump, 40002-0403
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 3 products — see all of them.

Details

Units affected
13,613
Illnesses reported
None reported
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Classification
Class II
Recall number
Z-2313-2026

In the FDA's words

Description
Plum Duo Precision IV Pump, 40002-0403 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. UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3 Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. Affected quantity: 13,613
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.

3 products in this recall

ICU Medical Plum infusion pumps recalled for missed dosing alerts

ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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