Fresenius Kabi USA, LLC is recalling the software for its Ivenix Infusion System (IIS) Large Volume Pump (LVP) due to a need for clearer instructions on programming the duration of infusions. The recall affects 30 units of software version 5.10.2 and prior, which were distributed to various healthcare facilities. Because this software is used in clinical settings to control the delivery of fluids and medications, healthcare providers must ensure they are using the correct programming steps found in the manual to prevent delivery errors. Users should contact the manufacturer directly to address software updates or receive corrected instructions.
Incorrectly programming the duration of an infusion could lead to the pump delivering medication or fluids at the wrong rate. This poses a risk of over-infusion or under-infusion, which can lead to serious health complications or death depending on the patient's condition and the medication being administered.
Quantity: 30 units; Emphasis on instructions for LVP duration programming located in the IFU.
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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