ICU Medical, Inc. — LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 24, 2025
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
What's affected?
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Brand
- ICU Medical, Inc.
- Lot code
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Additional details
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12 customers.
Get Health recall alerts
Delivered to your inbox. Free. No account required.