WhichRecall
Class IIReported 2025-12-31

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

Recalled by ICU Medical, Inc.

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)

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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.

Recall Number
Z-0966-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-24
Reported
2025-12-31
Distribution
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Code Info
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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