FDA-Device2025-12-31Class II
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
ICU Medical, Inc.
Hazard
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Sold states
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Affected count
12 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 Product No. 17003-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2026Don't want to check this manually?
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