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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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.
The software's Change Summary review option does not function correctly for some migrated libraries. This malfunction could result in the over delivery, under delivery, or setup delays of medication via infusion pumps.
There are no reported injuries or deaths associated with this recall. The recall affects seven specific customers who experienced the software malfunction.
Patients and healthcare providers should stop using the software immediately. Follow the recall instructions provided by ICU Medical, Inc., and contact your healthcare provider for further guidance.
For more information, contact ICU Medical at 1-800-XXX-XXXX or visit their website at www.icumed.com.
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