FDA-Device2025-12-31Class II
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
ICU Medical, Inc.
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-0965-2026Don't want to check this manually?
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