Reported Jan 21, 2026 · Ongoing
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Number 40002-04-01
- Lot codes and dates
- UDI-DIM335400021
- Serial Numbers
423 of 423 codes
500002215000029450000295500002965000029850000299500003005000030350000304500003095000166350001664500016655000166650001667500016685000166950001670500016715000167250001673500016745000167550001676500016775000167850001679500016805000168150001682500016835000168450001685500016865000168750001688500016895000169050001691500016925000169350001694500016955000169650001697500016985000169950001700500017015000170250001703500017045000170550001706500017075000170850001709500017105000171150001712
- Amount recalled
- 423 units
Where it was sold
- Nationwide
Why it was recalled
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
This product could cause temporary or reversible health problems — stop using it.
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