The FDA declined to answer. More than 80 batches of the masks have been recalled. But opting out of some of these cookies may have an effect on your browsing experience. The company’s recent acquisition of Integra LifeSciences’ (NSDQ:IART) extremities business will further that mission. Wanting to… […], HR VP Camille Chang Gilmore explains why the medtech giant is using data to shine light on healthcare inequality. The gowns are often included in a package, along with other surgical equipment. Face Mask Recall (Last update 07.07.20) At QCS we know how important it is to keep everyone safe, so we want to ensure you are aware of a product recall. Necessary cookies are absolutely essential for the website to function properly. Stream CBSN live or on demand for FREE on your TV, computer, tablet, or smartphone. In a recall notice issued by the Department of Health and Social Services on June 26, nursing homes were told that they should immediately stop using Cardinal Healthcare IIR masks and destroy them due to ” risk to personnel ”in the event of degradation of the masks. Cardinal Health improves the cost-effectiveness of healthcare. This website uses cookies to improve your experience. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. You also have the option to opt-out of these cookies. Cardinal Health Presource Kits are not part of this recall, but kits containing affected gowns should remain … More than 80 batches of the masks have been recalled. A recall notice has been issued for batches of surgical face masks issued to care homes and GPs. Alan Levine, CEO of Ballad Health in Tennessee, said they had to reschedule 200 surgeries. It did not tell the FDA. These cookies will be stored in your browser only with your consent. We also use third-party cookies that help us analyze and understand how you use this website. Ambu said on October 7 that it won a national single-use endoscopy contract in the single-use endoscope category of a “major U.S. group-purchasing organization.” The deal enables Ambu to serve a fifth of the acute care hospitals in the United… […], Olympus (TYO:7733) announced that it has received FDA 510(k) clearance for its PCF-H190T and PCF-HQ190 colonoscopes. Two days after the killing of George Floyd, CEO Michael Mahoney and the executive team issued a letter that not only condemned… […], Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. Cardinal Health has notified customers of an urgent medical device recall related to specific production lots of single-sterile and bulk non-sterile Cardinal Non-Reinforced Surgical Gowns, Cardinal Fabric-Reinforced Surgical Gowns and RoyalSilk Non-Reinforced Surgical Gowns. This category only includes cookies that ensures basic functionalities and security features of the website. Cardinal Health: Healthcare Solutions, Logistics & Supplies Care homes have been told to immediately stop using the Cardinal Healthcare IIR masks and to destroy them as they pose a “risk to staff” if they degrade, Sky News reported. Watch CBS News anytime, anywhere with the our 24/7 digital news network. Problems included gowns exposed to contaminants through open windows, failure to provide hand sanitation, and operators eating in the production area. Care homes have been told to immediately stop using the Cardinal Healthcare IIR masks and to destroy them as they pose a “risk to staff” if they degrade, Sky News reported. Neocis announced this week that it has raised $72 million in Series D financing to continue developing its Yomi robotic system for assisting dental implant surgery. The recall notice follows a warning issued in May after complaints about that the masks, some of which are more than seven years beyond their expiry date. Patty Post found herself sitting at her third doctor’s office visit in a week. When her third… […], Dr. Sally Saba joined Medtronic in March after leading a transformation at a major healthcare provider. "We still don't know if whether we've hit the worst of it or not," Levine said. It did not tell the FDA. Copyright © 2019 Promedia Publishing Ltd All Rights Reserved. When her caregiver decided to marry, she… […], Critical care comprises nearly 20% of Edwards’ revenue. Key Surgical, a portfolio… […], Telehealth is having its moment as the COVID-19 pandemic continues. NIH awarded the contracts in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. Back then, the company did testing and concluded there was "no impact to its products." A Department of Health and Social Care spokesperson said: “The safety of health, care and all frontline staff is our top priority. Cardinal Health continued using Siyang HolyMed to supply the firm with so-called Level 3 surgical gowns despite the Chinese contract manufacturer’s track record of quality worries dating back a few years. Copyright © 2020 CBS Interactive Inc.All rights reserved. Alternatively, you can read the update here: Type IIR masks – Cardinal Health . Report: Eli Lilly halts COVID-19 treatment trial, Diversity in medtech: Just 20% of executive roles held by women, CartiHeal wins FDA breakthrough designation for Agili-C implant, U.S. Supreme Court to hear Arthrex challenge to constitutionality of patent judges, FDA clears GE Healthcare AI-powered cardiovascular ultrasound system, Vaccine trial pause sees Johnson & Johnson dip despite strong Q3, Smith+Nephew is taking the road less traveled with its ortho surgical robotics, J&J halts COVID-19 vaccine trial due to illness, Abbott wins FDA EUA for COVID-19 IgM antibody test, MedTech 100 roundup: New peak for industry, DTW Podcast: Smith+Nephew’s Ortho president, Rhaeos’ big win and Medtronic’s legacy, CytoSorbents wins $1.1M DoD contract for universal plasma, Olympus gains 510(k) clearance for colonoscopes, Neocis raises $72M for Yomi robotic dental implant aid, Ambu, Xenecor ink purchasing deals for for single-use scopes, Bringing strep tests into the home in the new telehealth era, How Medtronic’s new diversity leader wants to make the company even better, AI could boost Edwards’ critical care business, How Boston Scientific can help close the gap in healthcare, J&J exec denies pressure to rush COVID-19 vaccine, NIH announces more than $98M in contracts for new COVID-19 testing tech. They… […]. Download the document here so you know which face masks are recalled. Earlier this month, care home operators were advised to destroy faulty COVID-19 test kits that had been manufactured by a Chinese company. Surgeries are now being canceled in some hospitals. The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing. app, BREAKING NEWS: Care home COVID-19 deaths rise for fourth consecutive week, Care home boss demands public inquiry following COVID outbreak. Dr. Jonathan LaPook is the chief medical correspondent for CBS News. CBS News asked the FDA if it conducted any inspections of the unregistered subcontractors uncovered by Cardinal Health. Follow him on Twitter at @DrLaPook. The issue is now resolved.”. Increasing manufacturing of similar and replacement products; Offering more protective AAMI Level 4 gowns to help bridge the supply gap; Working to identify alternatives — including in many cases working with industry partners who offer comparable products; Mobilizing employees to work directly with healthcare providers to replace gowns and procedure packs. One of Camille Chang Gilmore’s proudest moments at Boston Scientific came earlier this year. © 2020 CBS Interactive Inc. All Rights Reserved. Surgical gown recall leaves medical centers scrambling. Important Customer Alert - Cardinal Type IIR Face Masks. The Miami-based company claims that Yomi is… […], In this week’s DeviceTalks Weekly Podcast, our opening and closing keynote interviews focus on executives from companies at very different stages. […], Steris (NYSE:STE) announced this week that it has agreed to buy Key Surgical, a manufacturer of disposable hospital and surgical products, for $850 million. Center Valley, Pa.-based Olympus’ two newly cleared colonoscopes provide an extension to the existing capabilities of physicians to diagnose and treat disorders of the gastrointestinal tract, according to a news release. The company said these facilities did not "maintain proper environmental conditions." Its continued growth is connected to the prominence of the company’s heart valve business. WTWH Media LLC and its licensors. Meanwhile, the device maker has announced a second recall, this time related to its PreSource Kits that contain the recalled gowns.
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