Fresenius Kabi USA, LLC is recalling 6 units of the Ivenix Infusion System (IIS) Large Volume Pump, Model LVP-0004. The recall was initiated because the device's touchscreen may register "phantom" touches in the lower-left corner during operation, leading to unintended inputs. These phantom touches could potentially alter infusion settings or interrupt treatment, which may lead to patient harm. If you possess an affected pump, please contact the manufacturer to arrange for a device correction or replacement.
The touchscreen malfunction can cause the device to register commands that were not entered by a clinician. This may result in incorrect medication delivery rates or dosing errors, posing a risk of over-infusion or under-infusion for patients.
Potential issue causing phantom touches in the lower-left corner of the touchscreen.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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