The US Food and Drug Administration (FDA) has determined Fresenius Kabi USA’s recall of the Ivenix large volume pump (LVP) of the Ivenix Infusion System as Class 1, the most serious kind of recall.
Ivenix LVP, one of the three main components of the Ivenix Infusion System, is being recalled over mechanical issues of some units with the fluid valve pins, situated within the pump’s internal housing.
The pump is designed to use the air pressure to precisely control the flow of fluids to the patient.
The Ivenix Infusion System is used to deliver fluids to patients via routes like intravenous, in arteries, in the spine, or under the skin in hospitals and outpatient centres.
The mechanical interference causes the fluid valve pins to not move properly and impact the side of a sensor, said the FDA. When this occurs, the pump cannot function and the infusion, if it is already underway, is stopped by the alert that the system triggers upon detecting the failure.
The American health regulator said that there is a risk of underdosing, therapy interruption, or therapy delay during the use of the impacted product. This may also result in major injury or even death.
According to the FDA, Fresenius Kabi has reported no injuries or deaths related to the recall.
The company is recalling the Ivenix LVP products distributed between 1 October 2021 and 31 July 2023.
Currently, the German healthcare firm has recalled 938 devices in the US since it began the recall on 29 November 2023.
Fresenius Kabi has recommended the impacted customers increase clinical monitoring if the pump is being used to deliver life-sustaining medications.
In a similar development, the FDA has classified the recall of the continuous positive airway pressure (CPAP) masks with magnets by ResMed as Class 1.
ResMed is recalling the AirFit and AirTouch CPAP masks over their potential magnetic interference with certain medical devices.
The company has announced the recall of the masks to update the labels and include more warnings and information about the usage.
The US health agency has reported six injuries with no report of death.
