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Fresenius Kabi

Fresenius Kabi warns on Ivenix infusion pump valves

December 11, 2024 By Sean Whooley

Fresenius Kabi Ivenix infusion system

The FDA said Fresenius Kabi told customers to remove its Ivenix large-volume infusion pumps from use for repair. This warning from the FDA comes as part of its Communications Pilot to Enhance the Medical Device Recall Program. The agency became aware of a potentially high-risk device issue and plans to keep the public informed on […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Technology Tagged With: FDA, Fresenius Kabi

Fresenius Kabi recalls and removes some Ivenix infusion pump administration sets from market

September 19, 2024 By Sean Whooley

Fresenius Kabi Ivenix infusion system

The FDA issued a notice outlining a serious recall of Ivenix infusion pump administration sets from Fresenius Kabi. 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 […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceuticals, Technology Tagged With: FDA, Fresenius Kabi

Fresenius Kabi USA appoints new president

July 11, 2024 By Sean Whooley

Fresenius Kabi logo updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Personnel Tagged With: Fresenius Kabi, Personnel Moves

Fresenius Kabi has a Class I recall of Ivenix Infusion System software

April 18, 2024 By Danielle Kirsh

Fresenius Kabi Ivenix infusion system

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Technology Tagged With: FDA, Fresenius Kabi

Fresenius Kabi has a Class I Ivenix infusion pump recall

January 12, 2024 By Sean Whooley

Fresenius Kabi Ivenix infusion system

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. […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, Fresenius Kabi, freseniuskabi

Fresenius Kabi, Mayo Clinic ink deal on Ivenix infusion system

December 15, 2023 By Sean Whooley

Fresenius Kabi 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, […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, Hospital Care, Technology Tagged With: Fresenius Kabi, freseniuskabi, Ivenix

Fresenius Kabi launches single-needle option for extracorporeal photopheresis

April 24, 2023 By Sean Whooley

Fresenius Kabi logo updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Vascular Tagged With: Fresenius Kabi, freseniuskabi

Fresenius Kabi recall of Ivenix infusion systems in Class I

April 19, 2023 By Danielle Kirsh

Fresenius Kabi logo updated

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 […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Fresenius Kabi

Fresenius Kabi wins Vizient contract for Ivenix infusion system

April 18, 2023 By Danielle Kirsh

Fresenius Kabi Ivenix

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 […]

Filed Under: Business/Financial News, Hospital Care Tagged With: Fresenius Kabi

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