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Recall Observatory FDA recall evidence

Device product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Z-0966-2026

November 24, 2025

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 98022
Status
Ongoing
Classification
Class II
Quantity
12 customers
Official record key
device-enforcement:Z-0966-2026

Official wording

Reason: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

Code information: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Distribution pattern: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue