Company: ICU Medical, Inc.

Date of Enforcement Report: 5/14/2025
Class II

PRODUCT

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

Recall Number:

Z-1763-2025

REASON:

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

RECALLING FIRM/MANUFACTURER:

ICU Medical, Inc.

VOLUME:

12 US, 3 OUS

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.