Fresenius Kabi announced that Arunesh Verma joined as the president of Fresenius Kabi USA and as a member of its global executive leadership team. As a member of the executive leadership team, Verma reports to CEO Pierluigi Antonelli. He holds responsibility for the commercial operations of Fresenius Kabi in the U.S., succeeding John Ducker. Ducker […]
Fresenius Kabi
Fresenius Kabi has a Class I recall of Ivenix Infusion System software
The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
Fresenius Kabi, Mayo Clinic ink deal on Ivenix infusion system
Fresenius Kabi announced that it signed a multi-year purchase agreement with Mayo Clinic centered around large-volume infusion pumps. The Lake Zurich, Illinois-based company expects Mayo Clinic to purchase 10,000 Ivenix pumps for hospitals and clinics in Minnesota, Arizona and Florida. It marks the largest contract for Ivenix pumps signed by the company to date. Ivenix, […]
Fresenius Kabi launches single-needle option for extracorporeal photopheresis
Fresenius Kabi announced the availability of a single-needle venous access option for its Amicus extracorporeal photopheresis (ECP) system. The company announced its availability at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT). Fresenius Kabi first launched the Amicus Blue system with online ECP in Europe in 2019 with double-needle venous access […]
Fresenius Kabi recall of Ivenix infusion systems in Class I
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 […]
Fresenius Kabi wins Vizient contract for Ivenix infusion system
Fresenius Kabi this week announced its Ivenix infusion system was awarded an Innovative Technology contract from Vizient. Vizient members include more than half of all acute care hospitals in the U.S., and the Innovative Technology contracts are recommended after review and interaction with products submitted through the organization’s program. The contract sets terms for hospitals […]
Fresenius Kabi to acquire Ivenix and its smart infusion system for $240M upfront
Fresenius Kabi announced today that it will acquire Ivenix with plans to bring a comprehensive infusion product portfolio to the U.S. The acquisition, which has a purchase price of $240 million upfront, also includes potential milestone payments linked to achievements of commercial and operating targets. Get the full story at our sister site, Drug Delivery Business News.
FDA clears Fresenius Kabi wireless Agilia Connect infusion system
Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion system. Lake Zurich, Illinois–based Fresenius Kabi’s Agilia Connect infusion system includes the Agilia volumetric pump and the Agilia syringe pump with Vigilant software suite-Vigilant Master Med technology. Get the full story at our sister site, Drug Delivery Business News.
Fresenius Kabi recalls sodium acetate injection due to presence of particulate matter
Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection. Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or […]
Government warns on cybersecurity issue with Fresenius Kabi’s Agilia Connect infusion system
The U.S. Cyber Security & Infrastructure Security Agency today issued a medical advisory for the Fresenius Kabi Agilia Connect infusion system. Fresenius Kabi’s Agilia Connect infusion system has been deemed “exploitable remotely/low attack complexity” by the agency. Successful exploitation of vulnerabilities could allow an attacker to gain access to sensitive information, modify settings or parameters or perform […]
