FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath
Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…
FDA: Recall of Pharmacist Choice Alcohol Prep Pads
Editor's Note The Food and Drug Administration (FDA) on December 5 announced the recall of 3 lots of Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics (Coral Springs, Florida), which were manufactured by Foshan Flying Medical Products Co Ltd, located in China. The alcohol pads were recalled because of…
FDA: Baxter recalls one lot of injectable amiodarone
Editor's Note The Food and Drug Administration (FDA) on November 15 announced the recall by Baxter International (Deerfield, Illinois) of one lot of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection because of the presence of particulate matter. The particulate matter was identified as polyethylene, the primary constituent of the…
FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio). There is an issue with the artwork on the electrodes…
FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron
Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…
FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…
FDA: SCA pharmaceuticals recalls certain lots of injectable products
Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products. The recall was initiated because of the potential for the products to contain microbial contamination. Many of the recalled products are used in anesthesia,…
FDA updates Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…
FDA alerts healthcare providers about EVAR graft endoleaks
Editor's Note The Food & Drug Administration (FDA) on September 28 sent letters to vascular and cardiothoracic surgeons, radiologists, and cardiologists, alerting them to an increase in Type III endoleaks associated with endovascular graft systems used in endovascular aneurysm repair (EVAR) for abdominal aortic and aorto-iliac aneurysms. The FDA’s letter…
FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter
Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…
Free Daily News
- Man survives 100 days with artificial titanium heart, setting new milestone
- Study: Sleep-deprived nurses face higher infection risk
- Survey: Health system CEOs prioritize regulation, workforce, technology investments
- 2025 OR Manager Conference unveils next-level leadership strategies for ASCs and beyond
- UnitedHealth’s dominant growth forges ahead amid intensifying antitrust scrutiny
- Analysis: How the new US malpractice standard puts evidence-based ‘reasonable care’ over customary practice
- Healthgrades announces 2025 Patient Safety Excellence Award recipients
- Supreme Court case could threaten colorectal cancer screening access, ACG warns
- Study: CMS sepsis care protocol shows no clear mortality benefit
- Study: Implicit bias linked to low-value vascular procedures, worse outcomes for Black patients