Fresenius Kabi USA is recalling approximately 1,344 Ivenix Infusion System Large Volume Pumps running software versions 5.0.0 and 5.0.1. The recall was initiated because the pump's start-up time for certain flow rates (between 50 ml/hr and 200 ml/hr) can exceed the required 6-minute window. This delay occurs when air bubbles become trapped in the administration set's pumping chamber, which may lead to a significant delay in the delivery of critical fluids or medications to patients.
A delay in therapy initiation could result in the under-infusion of life-sustaining medications. Depending on the patient's condition and the medication being administered, this delay could cause serious health complications or the worsening of the condition being treated.
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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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