ICU Medical recalls Plum Solos infusion pumps with software version 1.1.1 that may bypass maximum dose limits, risking overdose. Affected units have specific serial numbers.
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 Solos infusion pumps that may bypass the maximum dose limit alert, potentially leading to overdose. This recall affects specific units with known serial numbers.
The software version 1.1.1 in these pumps may bypass the maximum dose limit alert, allowing the pump to administer doses higher than the set safety limit. This could lead to an overdose if the pump is programmed for weight or body surface area based medication rules.
Healthcare professionals using ICU Medical Plum Solos infusion pumps with software version 1.1.1 are most at risk. Patients receiving medication via these pumps could be affected if the device fails to alert about maximum dose limits.
Check if your Plum Solos infusion pump has software version 1.1.1. Affected units have specific serial numbers listed in the recall notice.
Verify your pump's software version; affected units have version 1.1.1.
Reach out to ICU Medical for guidance on next steps if your pump is affected.
Software version 1.1.1 in the Plum Solos infusion pumps.
Check if your pump has software version 1.1.1 and a serial number from the list provided in the recall notice.
No immediate stop is required, but affected units should be checked for software version and contacted for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1991-2025 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1991-2025 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.
