ICU Medical recalls LifeShield Drug Library Management software v2.2 due to concentration limit precision error. This may cause incorrect drug dosing if users adjust limits beyond manufacturer recommendations.
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). 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.
ICU Medical is recalling LifeShield Drug Library Management software version 2.2 because it only allows concentration limits to be set to one decimal place (0.1) instead of three (0.001). This could lead to incorrect drug dosing if users change limits to match manufacturer recommendations.
The software only allows concentration limits to be defined to one digit past the decimal (0.1) instead of three (0.001). If users change limits to match manufacturer recommendations, they might deliver too much or too little medication.
Healthcare professionals using LifeShield software for drug administration may be affected. Those who adjust concentration limits beyond the software's precision could face dosing errors.
Check for LifeShield Drug Library Management (DLM) software version 2.2 with Product No. 17003-02. The software also has UDI-DI 00887709127227.
Verify your software version by checking the product number or UDI-DI code on the software.
The software has a precision error that could lead to dosing errors if users adjust concentration limits beyond the software's precision. However, the risk is low if users follow manufacturer recommendations.
Check for LifeShield Drug Library Management (DLM) software version 2.2 with Product No. 17003-02 or UDI-DI 00887709127227.
The recall does not specify a remedy, so users should check their software version and contact ICU Medical if they need assistance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0966-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0966-2026 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.