BD (NYSE:BDX) announced today that it plans to invest further in U.S. manufacturing to add capacity for certain critical medical devices. Those medical devices include syringes, needles and IV catheters. The Franklin Lakes, New Jersey-based company aims to meet the ongoing needs of the nation’s healthcare system. This uptick in manufacturing follows last year’s capacity […]
BD
BD hit with FDA warning related to Pyxis medication management
The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of its $12 billion CareFusion acquisition in 2015. The warning letter, dated Nov. 22 and posted on Dec. 17, involves inspections conducted in May at a former CareFusion facility in San Diego. It notes near […]
BD to pay SEC $175M to settle Alaris investigation
BD (NYSE:BDX) announced that it reached an agreement with the SEC to resolve an investigation related to its Alaris system. The investigation relates to prior public disclosures and SEC reporting regarding Alaris, an infusion pump system. BD neither admits nor denies the findings of an SEC order related to those matters occurring more than four years […]
Ypsomed, BD collab on self-injection systems for high-viscosity biologics
BD (NYSE:BDX) and Ypsomed today announced a strategic collaboration to advance self-injection solutions for high-viscosity biologic drugs. In a joint project, the companies pre-assessed and streamlined the integration of the BD Neopak XtraFlow glass prefillable syringe with the Ypsomed YpsoMate 2.25 auto-injector platform. They aim to address current limitations by enabling the delivery of higher-viscosity […]
BD partners with ten23 health on prefilled syringe manufacturing
BD (NYSE:BDX) announced today that it entered into a collaboration with ten23 health to develop a new way to track prefillable syringes (PFS). ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. It recently entered into a production collaboration with on-body drug delivery device maker […]
BD launches new prefillable syringe, expands platform capacity
BD (NYSE:BDX) announced today that it launched its Neopak XtraFlow glass prefillable syringe and expanded the capacity for the platform. The company said the launch and expansion aim to serve the growing market for biologic therapies. Neopak glass prefillable syringes address key development needs for biologic drugs, BD said in a news release. The syringes […]
BD warns on some neXus V700 infusion pumps outside the U.S.
BD [WtwhTicker symbol=”BDX”](NYSE: BDX)[/WtwhTicker] issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The […]
BD ups domestic syringe production in wake of FDA warnings on syringes made in China
BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality […]
BD inks $85M settlement over Alaris defect disclosure claims
BD (NYSE:BDX) announced that it filed settlement documents for an $85 million agreement to resolve claims regarding its Alaris infusion pump technology. The Alaris system has been much maligned over the past few years. Its troubles date back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software […]
BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes
The FDA determined that another recall of BD (NYSE:BDX) Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. […]
