ICU Medical recalls Plum Duo infusion pumps with software version 1.1.1 that may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses. Affected units have specific item numbers and serial numbers listed in the recall.
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.
ICU Medical is recalling certain Plum Duo infusion pumps that have a software version (1.1.1) which may bypass the Maximum Dose Limit alert. This could allow unsafe medication doses to be administered without proper safety checks. Affected pumps have specific item numbers and serial numbers listed in the recall.
The software version 1.1.1 may bypass the Maximum Dose Limit alert, which is set in the LifeShield Drug Library Manager. This could allow unsafe medication doses to be administered without proper safety checks, potentially leading to overdoses.
Patients using ICU Medical Plum Duo infusion pumps with software version 1.1.1 are most at risk. Affected units include specific item numbers and serial numbers listed in the recall.
Check if your Plum Duo pump has item numbers 400020401, 400021001, or 400021003 with specific serial numbers listed in the recall. The recall includes detailed lists of affected serial numbers.
Verify your Plum Duo pump's software version. If it is 1.1.1, it is affected by this recall.
Contact ICU Medical directly to confirm if your pump is affected and to get instructions for next steps.
Your pump is affected if it has item numbers 400020401, 400021001, or 400021003 with specific serial numbers listed in the recall.
Contact ICU Medical directly to confirm if your pump is affected and to get instructions for next steps.
Check your pump's software version. If it is 1.1.1, it is affected by this recall.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1990-2025 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1990-2025 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.
