Fresenius Kabi’s Ivenix Infusion System Gets Another Class I Recall

A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version 5.8.0 LVP software.

The software glitches can cause over- or under-dosing or delays in therapy delivery, “which could lead to serious patient harm or death,” the agency said. “To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP).”

There have been no reports of injuries or deaths associated with the software issue, the agency added, but in January, the company recalled the pump itself because mechanical issues in certain units could cause the product’s fluid valve pins to move improperly, resulting in the device failing to sound an alarm if needed and ceasing to operate.

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