Medical Device Recall: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical, Inc. · May 2, 2025
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
States Affected
NATIONWIDE
Quantity Affected
12 US, 3 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1763-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.