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

Medical DevicesSource: FDA (device) · Date: 2025-12-31

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ICU Medical, Inc.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Recall initiated
2025-11-24
Code info
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Product quantity
12 customers
Voluntary mandated
Voluntary: Firm initiated
City
Lake Forest
State
IL
Country
United States
Event id
98022
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