FDA Safety Communication: UPDATE on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates
MedSun: Newsletter #75, August 2012

FDA Medical Device Safety

The FDA is issuing this communication to inform personnel at facilities that utilize Sterrad sterilizers of the following:

*ASP has issued a voluntary recall of Sterrad Cyclesure 24 Biological Indicators due to the revised expiration time (shelf life) from 15 months to 6 months. This recall followed an FDA review of ASP data, which showed that the Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout a 15-month shelf life.

*Use of Sterrad Cyclesure 24 Biological Indicators beyond their 6-month shelf life may prevent verification of proper sterilization. However, the FDA believes that the risk of infection for an individual patient is very low, given that this biological indicator is only one of three sterilization system monitors and the window of possible exposure to the malfunctioning Cyclesure 24 devices is relatively short.

*Supplies of Sterrad Cyclesure 24 Biological Indicators may be temporarily reduced. The FDA is working with ASP to make suitable product available and to assure that health care facilities experience little or no disruption.

Only the lot numbers of Sterrad Cyclesure 24 Biological Indicators that are listed in ASP’s Recall Alert are affected by ASP’s voluntary recall. In order to determine if the Sterrad Cyclesure 24 Biological Indicators you have in inventory are subject to this recall, please refer to the list of affected lots found in ASP’s Recall Alert.

Additional Information:

FDA Medical Device Safety. FDA Safety Communication: UPDATE on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates . July 7, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310549.htm


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