The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind.
Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.
The leak could damage the electrical system and result in a loss of power and failure of the system’s set identification sensor, which can delay or interrupt treatments. This issue may cause serious injury or death to patients due to interruption, under-infusion or delays in the delivery of critical fluids, blood products and medication, according to an FDA notice.
Fresenius Kabi has received 14 complaints related to this issue. There have been no reported injuries or deaths.