FDA recall Z-0966-2026

ICU Medical, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-11-24
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2026