Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LifeShield Drug Library Management (DLM) Recalled by ICU Medical, Inc. Due to Firm has identified Drug Library Management defects in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected Products
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Quantity: 12 US, 3 OUS
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report