This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type as it may cause serious injury or death.
Fresenius Kabi recalled certain lots of the Ivenix LVP primary administration sets after identifying a manufacturing defect. This may cause uncontrolled medication flow, potentially leading to medication overdose and death. The company reports two injuries related to the issue and zero deaths.
One of three primary components of the Ivenix infusion system, the LVP (large-volume pump) uses air pressure to precisely control fluid flow. The systems use extends to hospitals and outpatient centers for careful administration of fluids to patients. Routes include IVs, in arteries, in the spine or under the skin. Its indications cover adults, pediatrics and newborn babies. The LVP is compatible only with specific sterile, single-use, disposable administration sets.
Fresenius Kabi’s Ivenix infusion system faced a software recall earlier this year, too.
The recall affects the Ivenix LVP primary administration sets dual-inlet, low-sorbing, needle-free port, y-site (Qty 25). It’s specific to lot 3010538. Other lots remain unaffected.
Fresenius Kabi sent out an urgent voluntary recall letter on Aug. 2, 2024. It recommended that customers stop using and distributing affected product immediately. They should check inventory and quarantine affected product and destroy or return that affected product and request replacements.
