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FDA alerts hospitals, surgical centers to additional sterilizer product

November 9, 2012

The Food and Drug Administration yesterday announced additional recalls of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems. The agency said that Advanced Sterilization Products has issued a recall of all lots of Sterrad Cyclesure 24 Biological Indicators manufactured between February 2008 and December 2011 because of insufficient data to support the labeled expiration time. FDA recommends hospitals and other health care facilities check the lot number printed on packaging components of Sterrad Cyclesure 24 Biological Indicator and determine if products are subject to this recall; stop using affected products; immediately return affected products as instructed in the ASP recall notice; and use an appropriate alternative sterilizer if available. This recall is in addition to the lot numbers of Sterrad Cyclesure 24 Biological Indicators that are listed in ASP's July recall notice.