Reported May 21, 2025 · Ongoing
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Lot codes and dates
- LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
- Amount recalled
- 12 US, 3 OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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