January 24, 2010Recalls and Safety Alerts: Energy Levels in External Biphasic Defibrillators Recalls and Safety Alerts: Energy Levels in External Biphasic Defibrillators
FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance. Over the past three years, FDA has received reports of 14 ... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Serious Complications with Negative Pressure Wound Therapy FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from... Source: www.accessdata.fda.gov U.S. Attorney News Release: Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices Spectranetics Corporation, a medical device manufacturer, located in Colorado Springs, Colorado, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today. Source: www.fda.gov FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year. Source: www.fda.gov FDA Ends Maryland Seafood Processor’s Pattern of Sanitary Violations The FDA today announced that a Maryland seafood processor delivering fresh, frozen, and ready-to-eat seafood in Virginia, Pennsylvania, and New Jersey, and Washington, D.C., is to stop processing and distributing adulterated fish and seafood because it is not compliant with federal food safety laws. Source: www.fda.gov FDA Warns Consumers about Counterfeit Alli The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking. Source: www.fda.gov FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of “Best By 111911” because the product may be contaminated with Salmonella. Source: www.fda.gov FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine. Source: www.fda.gov # posted by Network @ 10:03 PM
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