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Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection
[UPDATED 07/06/2012] The FDA issued a clarification for personnel at facilities that utilize Sterrad sterilizers:
- The voluntary recall is for only certain lots of Sterrad Cyclesure 24 Biological Indicators. FDA review of ASP data showed that certain lots of Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout a 15-month shelf life.
- ASP made a change in December 2011 to the materials used to manufacture the product. Product lots manufactured prior to this material change are not subject to the recall.
- Refer to the list of affected lots found in ASP’s Recall Alert <http://www.aspjj.com/us/news/cyclesureletter> to determine if the product in inventory is subject to this recall.
Read the MedWatch safety alert, including a link to the updated FDA Safety Communication, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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