Reported Jun 25, 2025 · Ongoing
ICU Medical Plum Solos, Item number 400011001; infusion pump
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?
- ICU Medical Plum Solos, Item number 400011001; infusion pump
- Lot codes and dates
- UDI/DI N/A
- Serial/Lot Numbers
214 of 214 codes
600000016000000260000003600000056000000660000007600000086000000960000010600000116000001460000015600000166000001760000019600000206000002160000023600000246000002560000026600000276000002860000030600000326000003360000035600000386000003960000040600000416000004260000044600000456000004660000047600000486000004960000050600000516000005260000053600000546000005660000057600000586000005960000060600000616000006260000063600000646000006560000066600000676000006860000069600000706000007160000072
- Amount recalled
- 214 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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