FDA designates Class 1 recall for infusion system components

Editor's Note

The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death.

According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538) of Large Volume Pump (LVP) Primary Administration Sets. One of three primary components of the infusion system, the LVP uses air pressure to control the flow of fluids to patients via IV, in arteries, under the skin, or through the spine. The recall was prompted by risk of a manufacturing defect causing uncontrolled medication flow, which has resulted in two reports of injuries and zero deaths.

Manufacturer recommendations for customers include ceasing use and destroying or returning defective products for replacements.