Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; 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 Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
- Lot codes and dates
- UDI/DI +M335400011
- Serial Numbers
5,059 of 5,059 codes
600003166000036360000375600003886000042860000451600004696000049560000529600005696000058060000637600006436000064760000652600006686000067060000689600006926000069560000703600007066000071060000712600007166000071860000724600007266000075460000757600007596000076560000775600007766000078160000790600007936000080160000805600008166000083060000835600008506000085760000860600008796000088360000886600008996000090360000909600009166000091760000920600009276000093360000938600009396000094260000944
- Amount recalled
- 5059 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
- Nationwide
Why it was recalled
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
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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