FDA-Device2025-12-31Class IIPROCESSING DEFECT

ICU Medical LifeShield Drug Library Management software recall for change review malfunction

OTHERNationwide distribution

Check ICU Medical LifeShield Drug Library settings

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
Hazard

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.

Sold states
US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Affected count
7 customers
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2026

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