Adven Medical, Lubbock, Texas, agreed to stop reprocessing and distributing medical devices until it corrects manufacturing problems in a consent degree with the Food and Drug Administration. The FDA said it cited the company for numerous violations of good manufacturing practices, including failure to validate its cleaning, disinfecting and sterilization process and lack of procedures to prevent and correct manufacturing problems. Adven President and CEO Mark Aldana said he expected the facility would be closed four weeks to six weeks. "Our science is solid. Other third-party reprocessors have used us as consultants," Aldana said. "We're looking forward to getting over this." Adven reprocesses single-use medical devices such as biopsy forceps, blood pressure cuffs and catheters. -- by Cinda Becker
Device reprocessor will close plant to fix problems
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