ICU Medical recalled LifeShield Drug Library Management software on November 24, 2025. A software issue limits concentration precision to one decimal place, risking incorrect drug dosages. Users should stop using the product immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
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Product Name: LifeShield Infusion Safety Software Suite v2.2. Model Number: 17003-02. Quantity: 12 units distributed nationwide in California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee, and Virginia.
The software only allows concentration limits to be set with one digit of precision past the decimal point. This limitation may lead to incorrect drug delivery, resulting in potential over- or under-dosage.
No specific injuries or incidents have been reported related to this software issue. However, the potential for harm exists if dosage limits are altered inadvertently.
Stop using the LifeShield Drug Library Management software immediately. Contact ICU Medical, Inc. or your healthcare provider for further instructions and follow the recall guidelines.
For more information, call ICU Medical at their customer support line or visit their website. Additional details can be found at the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0966-2026.
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