FDA Enforcement
Class II
Ongoing
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Recall: Z-0966-2026
·
Reported December 31, 2025
Enforcement
- Recall Number
- Z-0966-2026
- Event ID
- 98022
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ICU Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2025
- Initiation Date
- November 24, 2025
- Classification Date
- December 19, 2025
- Address
- 600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States
Description
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
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 Info
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Distribution
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Quantity
12 customers