medical Class II Updated 2025-05-21

ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusio

Recalled Product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
View official government recall

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