January 13, 2010U.S. Attorney News Release: Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices 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's MedWatch Safety Alerts: October 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund. Source: www.fda.gov FDA Takes Action Against New Jersey Cheese Manufacturer The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes. Source: www.fda.gov Improper Use of Decorative Contact Lenses May Haunt You As Halloween approaches, FDA reminds consumers that non-prescription decorative contact lenses may harm their vision. Source: www.fda.gov Warning on Body Building Products (video) In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances. Source: www.fda.gov Negative Pressure Wound Devices Draw FDA Notice, Advice FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy. Source: www.fda.gov # posted by Network @ 1:28 PM
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