Home / Recalls / Medical Devices
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Recalled May 21, 2025 · FDA recall Z-1763-2025 · ICU Medical
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. · FDA Class II
Units
12 US, 3 OUS
Sold at
Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
Description
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.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →