ICU Medical recalls LifeShield Drug Library Management software versions v2.1 and v2.2 due to potential over-delivery of drugs or incorrect therapy parameters. Affected users should contact for remedy.
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.
ICU Medical is recalling two versions of their LifeShield Drug Library Management software because flaws could lead to giving patients too much medication or incorrect treatment settings. This is serious for healthcare providers using the software daily.
The software has two defects: it cannot create percentage dose rate values with limits, which might cause over-delivery of drugs, and unauthorized users could change drug library settings, leading to incorrect therapy parameters.
Healthcare providers using LifeShield Drug Library Management software versions v2.1 and v2.2 are most at risk. This includes hospitals and clinics that rely on the software for medication management.
Check if you have LifeShield Drug Library Management software versions v2.1 or v2.2. The product has a UDI-DI code 00887709122802.
Reach out to ICU Medical for guidance on the remedy for affected software versions.
Yes, the software could lead to over-delivery of drugs or incorrect therapy settings if defects are not fixed.
LifeShield Drug Library Management software versions v2.1 and v2.2.
Look for the UDI-DI code 00887709122802 on the software or check the product details.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1763-2025 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1763-2025 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.