Company: ICU Medical, Inc.
Date of Enforcement Report: 12/19/2025
Class: II
PRODUCT
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Recall Number:
Z-0966-2026
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.
RECALLING FIRM/MANUFACTURER:
ICU Medical, Inc.
VOLUME:
12 customers
DISTRIBUTION:
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
