ICU Medical recalled the LifeShield Infusion Safety Software Suite v2.2 on November 24, 2025. The software fails to operate as expected for migrated libraries, risking medication delivery errors. The recall affects seven customers across several states, including California and New York.
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
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 designed to manage drug libraries for infusion pumps, ensuring safe medication delivery. Healthcare providers use it to prevent medication errors during infusion therapies.
The software's malfunction prevents users from properly reviewing medication changes, which could lead to incorrect dosages being administered. This poses a significant risk to patient safety, particularly in critical care settings.
This recall is not part of a broader industry pattern.
The recall affects a small number of users, but those impacted may face serious risks associated with incorrect medication delivery. Immediate action is necessary to prevent potential harm.
You can find the software version and list number in the program settings or documentation provided during installation.
Expect a timeline of 4-6 weeks for refund processing or replacement.
Document all communications regarding the recall, including emails and receipts for the software.
The recall involves LifeShield Infusion Safety Software Suite v2.2, List Number 17003-02. This software was distributed nationwide in states such as California, Iowa, Louisiana, New York, Pennsylvania, Tennessee, and Virginia. It is designed for use with infusion pumps.
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