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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LifeShield Infusion Safety Software Suite v2.2 is used in healthcare settings to manage drug concentrations during infusion treatments. It is essential for ensuring accurate drug delivery to patients.
The software's limitation to one decimal place for concentration limits may force healthcare providers to alter dosing recommendations, leading to incorrect medication administration.
This recall is not part of a broader industry pattern.
The recall requires immediate attention from healthcare providers to prevent potential dosage errors, which could affect patient safety.
You can find the model number on the software interface or in the product documentation provided by ICU Medical.
Expect a response regarding the recall and any potential refunds within 4-6 weeks.
Keep records of your software purchase, correspondence with ICU Medical, and any relevant documentation related to the recall.
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.
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