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. since initiating the recall on Nov. 29, 2023.
The company reports no injuries or deaths related to the recall, according to the FDA.
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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, a uniquely designed infusion system, features a smart pump with a smartphone-like touchscreen and patented pumping mechanism. The pumps also interface with hospital information systems and electronic medical records. Fresenius Kabi acquired the Ivenix pump technology for $240 million in 2022.
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Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem.
The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage.
Radiologists use contrast agents to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.
“Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of gadoterate meglumine injection, USP,” said John Ducker, president and CEO of Fresenius Kabi USA, in a news release. “Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi gadoterate meglumine will provi…
Fresenius Kabi has announced a three-year plan to add GS1 Data Matrix barcodes to its pharmaceutical portfolio.
GS1 Data Matrix barcodes are also known as 2D barcodes.
The company manufactures a range of vials, syringes, IV products and parenteral nutrition products.
The Lake Zurich, Illinois–based company says the decision will reduce the need for manual data entry by automating the identification and verification of products in medication management systems.
Fresenius Kabi USA boasts that it is the first pharmaceutical company planning to incorporate GS1 Data Matrix barcodes on its drug product labels.
The company tested the initiative on some of its IV products earlier this year. Fresenius Kabi plans to add the barcodes to vials in the early fall.
Data Matrix barcodes include more information than traditional barcodes.
Fresenius Kabi plans to use the barcodes to include lot numbers and expiration dates.
The…
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.
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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.
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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 stability sample vials.
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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 arbitrary actions as an authenticated user.
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Omnicell (NSDQ:OMCL) and Fresenius Kabi announced today that they are collaborating on new technology for managing controlled substances.
The collaboration aims to provide U.S. hospitals and health systems with innovative new pharmacy technology designed to support safety and efficiency in dispensing controlled substances in patient care areas.
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Lake Zurich, Ill.-based Fresenius Kabi’s proprietary Simplist ready-to-administer prefilled syringe offers the fentanyl citrate injection at 50 mcg per 1 mL in an effort to reduce waste and diversion while ensuring the safe delivery of medication.
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Lake Zurich, Ill.–based Fresenius Kabi’s Heparin sodium in sodium chloride injection at a concentration of two USP units per ml is indicated as an anticoagulant to maintain catheter patency, according to a news release.
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Although March brought on tough times for top stocks in the medtech industry, April is already showing signs of a rebound.
The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the index hitting its lowest recent point on March 8 (102.16), marking a fall at a level not seen since October.
Even after a handful of slight improvements over the month of March, the industry never quite found its footing, ending the month below the 105-point mark.
The first week of April has already presented positive movement, though, with the industry rising to 106.26 points as the week ended on April 2, a 1.3% rise from the 104.87-point mark set the week prior on March 26.
Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry…