ICU Medical recalls Plum Duo Infusion Pump model 40002-0401 due to potential under- or over-delivery of medication. 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 Duo Infusion Pump model 40002-0401 because it may not warn clinicians when medication delivery goes too fast or too slow. This could lead to incorrect dosing of critical medications.
The pump may not display a soft limit alert, meaning it could deliver medication too quickly or too slowly without warning the clinician. This risk exists under certain conditions that aren't specified in the recall notice.
Healthcare professionals using the Plum Duo Infusion Pump for medical treatments are most at risk. Patients receiving medication via this pump could be affected if the device fails to alert clinicians.
Check for the model number 40002-0401 on the pump or its packaging. The pump also has a unique identifier M335400021 for version 1.2.3.
Verify the model number on the pump or its packaging to confirm if it is 40002-0401.
Reach out to ICU Medical directly for guidance on next steps if you have the recalled model.
The recall states the pump may not alert clinicians of soft limit violations, which could lead to under- or over-delivery of medication. This poses a risk to patients receiving treatment.
Check for the model number 40002-0401 on the pump or its packaging. The pump also has a unique identifier M335400021 for version 1.2.3.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2312-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2312-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
