ICU Medical recalls Plum Solo Precision IV Pumps (40001-0401) due to potential under- or over-delivery of medications. Affected units may not alert clinicians of soft limit violations.
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.
ICU Medical is recalling its Plum Solo Precision IV Pump model 40001-0401 because it might not warn clinicians when medication delivery goes too fast or too slow. This could lead to incorrect dosing of critical drugs.
The pump may not display a soft limit alert, meaning it could deliver too much or too little medication without warning the clinician. This risk exists when the pump is used in medical settings where precise dosing is critical.
Healthcare providers using the Plum Solo Precision IV Pump for medical treatments are most at risk. Patients receiving IV medications through this pump could be affected if the device fails to alert clinicians.
Check for the model number 40001-0401 on the pump's label. The pump also has a unique identifier M335400011 for version v1.0.3.
Look for the model number 40001-0401 on the pump's label or unique identifier M335400011 for version v1.0.3.
The pump may not alert clinicians when medication delivery goes too fast or too slow, potentially causing under- or over-delivery of drugs.
Check the model number on the pump's label. If it matches 40001-0401, contact ICU Medical for guidance.
The affected model is 40001-0401 with unique identifier M335400011 for version v1.0.3.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2311-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2311-2026 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
