ICU Medical recalls LifeShield Drug Library Management v2.2.1 for migration issues that may cause infusion pump delivery errors. Affected users must use alternate methods to review changes after migration.
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
ICU Medical is recalling LifeShield Drug Library Management software version 2.2.1 because some users may experience delivery errors with infusion pumps after migrating from an older version. This happens if the software stops properly reviewing changes to drug libraries.
After migrating from an older version of the software, the system may stop correctly reviewing changes to drug libraries. This can cause infusion pumps to deliver too much, too little, or delay setup of medications.
Users who migrated from LifeShield DLM v2.1x to v2.2.1 and have a Plum Duo v1.1 drug library approved or locked for review before migration. Healthcare providers using infusion pumps with this software are most at risk.
Check if you migrated from LifeShield DLM v2.1x to v2.2.1 and have a Plum Duo v1.1 drug library that was approved or locked for review before the migration. The software version is 2.2.1 with UDI-DI 00887709127227.
Verify if you migrated from LifeShield DLM v2.1x to v2.2.1 and have a Plum Duo v1.1 drug library approved or locked for review before migration.
The recall is because the Change Summary review option stops working after migration, which may cause infusion pump delivery errors like over delivery, under delivery, or delays in setup.
You must use alternate methods to review changes to drug libraries after migration to avoid delivery errors with infusion pumps.
The recall record does not mention a specific fix or remedy; users must use alternate methods to review changes.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0965-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0965-2026 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.
