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The U.S. Food and Drug Administration has issued a Safety Communnication regarding the Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), which is a product used with Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process. ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line. ASP is able to ship only 30 percent of its normal capacity for the Sterrad Cyclesure 24 Biological Indicator. ASP expects to increase production by July 2014 and anticipates being able to meet the full product demand by August 2014. The FDA does not have safety concerns about the Sterrad sterilizers, which are used for heat-sensitive medical devices that must be sterilized at low temperatures and low moisture, such as flexible endoscopes, cameras, some rigid scopes, light cords, batteries, and power drills. For more information, please see http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm398729.htm
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