Fresenius Kabi USA, LLC is recalling 30 units of the Ivenix Infusion System (IIS) LVP Software, specifically versions 5.10.1 and earlier. This software is used to control the administration of fluids to patients, and the recall was initiated because the software contains anomalies that could cause the system to malfunction. These defects have the potential to cause serious patient harm or death. Users are advised to stop using the affected software and contact the manufacturer to arrange for a correction or update.
The software anomalies can interfere with the controlled administration of life-sustaining fluids, leading to incorrect dosing or pump failure. This poses a significant risk of serious injury or death to the patient depending on the type of medication or fluid being delivered.
30 units affected; Software for the controlled administration of fluids to patients.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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