FDA: Edge Pharma issues nationwide recall of all drug products
Editor's Note The Food and Drug Administration (FDA) on December 7 announced that Edge Pharma, LLC (Colchester, Vermont) has issued a nationwide recall of all drug products. The recall was initiated because of process issues that could lead to a lack of sterility assurance for products intended to be sterile…
Change in volume of surgical procedures during COVID-19 pandemic
Editor's Note In this study, researchers from Stanford University School of Medicine find that the initial COVID-19 shutdown from March through April 2020 resulted in a decrease in surgical volume to nearly half of baseline rates. After the reopening, surgical volume rebounded to 2019 levels, and the trend was maintained.…
FDA: Class I recall of Teleflex percutaneous thrombolytic device kit
Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…
FDA: Nationwide recall of certain SterRx drug products
Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…
FDA: Class I recall of Aligned Medical Solutions custom convenience kits
Editor's Note The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious. The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride),…
FDA investigating imported surgical, exam gloves
Editor's Note The Food and Drug Administration (FDA), on September 29, announced that healthcare facilities and providers should not purchase or use imported surgical and patient examination gloves from companies included on Import Alert 80-04. Companies are listed on an import alert when the FDA has enough evidence that they…
FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs
Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…
FDA: Class I recall of DeRoyal procedure packs containing Smiths Medical Normoflo irrigation warming sets
Editor's Note The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious. The recall was initiated because of the possibility of harmful levels of aluminum leaching into the…
ECRI issues statement on COVID-19 vaccine boosters, global vaccine equity
Editor's Note In an October 26 news release, ECRI announced the publication of a Position Statement on “COVID-19 Vaccines: Mitigating Disease and Promoting Global Health Equity.” Speaking in support of the Statement, Marcus Schabacker, MD, PhD, president and chief executive officer, ECRI, says: “Despite the FDA and CDC’s advancement of…
CDC expands eligibility for COVID-19 boosters
Editor's Note The Centers for Disease Control and Prevention (CDC) director Rochelle P. Walensky, MD, MPH, on October 21, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation for a booster of COVID-19 vaccines in certain populations. For individuals who received Pfizer-BioNTech or Moderna COVID-19 vaccines, the following are eligible…
Free Daily News
- Moody’s downgrades health insurance outlook as medical costs surge
- Criminalizing anesthesia errors has unintended consequences, experts warn
- FDA approves new non-opioid analgesic
- Legislation proposes to halt Medicare physician payment cuts
- Cigna ties executive pay to patient experience
- Proposed tax credit aims to bolster nurse preceptor ranks
- Study links financial conflicts of interest to favorable robotic bariatric surgery research
- Hospitals double down on ambulatory care expansion with major investments
- Study: Post-laparotomy incisional negative pressure wound therapy fails to reduce infection risk
- FDA announces multiple Class 1 recalls