ICU Medical LifeShield Drug Library Management software recall for change review malfunction
What this means
ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.
- If you use LifeShield DLM v2.2.1 with Plum Duo v1.1, verify your Change Summary review tool is working after any recent library migration
- Use alternate review methods to check library changes until your system is corrected
- Contact ICU Medical customer support for guidance on your specific setup
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2026More ICU Medical recalls
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
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