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Recall Observatory FDA recall evidence

Device product

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

Z-1763-2025

May 02, 2025

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 96771
Status
Ongoing
Classification
Class II
Quantity
12 US, 3 OUS
Official record key
device-enforcement:Z-1763-2025

Official wording

Reason: 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.

Code information: LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.