FDA Recall: Defects in the software potentially resulting in over-delivery to patient

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.