Reported Aug 13, 2025 · Ongoing

Plum Duo Infusion System, List Number: 400020401

ICU Medical, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical, Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • Plum Duo Infusion System
  • List Number400020401
Lot codes and dates
  • UDI-DIM335400021
  • Serial Numbers

    3,618 of 3,618 codes

    • 50000124
    • 50004386
    • 50006225
    • 50000300
    • 50003767
    • 50006228
    • 50004719
    • 50005562
    • 50001512
    • 50002063
    • 50002087
    • 50000125
    • 50004387
    • 50006224
    • 50001628
    • 50003768
    • 50006227
    • 50004720
    • 50005566
    • 50001513
    • 50002064
    • 50002091
    • 50000126
    • 50004389
    • 50006223
    • 50001785
    • 50003775
    • 50006218
    • 50004722
    • 50005572
    • 50001514
    • 50002065
    • 50002107
    • 50000127
    • 50004390
    • 50006220
    • 50002461
    • 50003776
    • 50006205
    • 50004725
    • 50005619
    • 50001515
    • 50002066
    • 50002114
    • 50000128
    • 50004391
    • 50006217
    • 50002491
    • 50003785
    • 50006198
    • 50004726
    • 50005639
    • 50001516
    • 50002067
    • 50002120
    • 50000129
    • 50004392
    • 50006215
    • 50002541
    • 50003786
    50
Amount recalled
4677 units

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.