FDA-Device2025-05-21Class II
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical, Inc.
Hazard
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Sold states
Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
Affected count
12 US, 3 OUS
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2025Don't want to check this manually?
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