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Cardinal Health (NYSE: CAH) was awarded a $57.8 million contract, including options that if exercised by the U.S. Department of Health and Human Services (HHS) could reach $91.6 million, for the...

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Cardinal Health Durablue™ Sterilization Wrap Receives FDA Clearance For Extended Sterility Maintenance Indications
09/13/2012
Latest Clearance means DuraBlue™ Sterilization Wrap is the only dual-layered sterilization wrap where the entire product line has longer-than 30-day sterility maintenance test data cleared by the FDA

DUBLIN, Ohio, Sept. 13, 2012Cardinal Health today announced that DuraBlue™ Sterilization Wrap has been granted Food and Drug Administration (FDA) clearance (K120658) for extended sterility maintenance indications. This latest clearance makes DuraBlue™ Sterilization Wrap the only dual-layered sterilization wrap in the U.S. market where the entire product line has longer-than 30-day sterility maintenance test data cleared by the FDA.

Data from an event-related shelf life study of 180 days, or six months, was reviewed by the FDA as part of this clearance. The updated sterility maintenance indications are based on validation of wrap sterilized via the Johnson & Johnson STERRAD® 100S and STERIS Amsco® V-PRO® Systems.

“We understand how important extended sterility maintenance testing is to our customers, and we pursued this testing out of our dedication to product quality and performance,” said Lisa Ashby, president, Category Management at Cardinal Health.

Cardinal Health is currently finalizing extended shelf life testing for Pre-Vacuum Steam and Ethylene Oxide sterilization systems. The company expects to submit results of that testing to the FDA for acceptance in the very near future.

DuraBlue™ Sterilization Wrap is also cleared by the FDA for use in the most sterilization modalities of any dual-layered sterilization wrap in the market today. DuraBlue™ Sterilization Wrap is currently the only sterilization wrap on the market with FDA clearance for use with any of the Johnson & Johnson STERRAD® Sterilization Systems. The following is a comprehensive list of all sterilization systems for which DuraBlue™ Sterilization Wrap has FDA clearance:

  • Pre-Vacuum Steam
  • Ethylene Oxide
  • Johnson & Johnson STERRAD® 100S
  • All cycles (Lumen, Non-Lumen and Flexible Cycles) of the STERIS Amsco® V-PRO® 1, 1 Plus, and maX Sterilization Systems

To learn more about the new Cardinal Health DuraBlue Sterilization Wrap product, contact Katie Brothern at Katie.brothen@cardinalhealth.com or 1-847-887-3326.

 About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $108 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while  reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #21 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com and @CardinalHealth on Twitter.

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