FDA Recommended Steps for Sterrad Cyclesure 24 Biological Indicators

July 5, 2012

Advanced Sterilization Products (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, according to the US Food and Drug Administration (FDA).

If your ASC uses Sterrad Cyclesure 24 Biological Indicators, the FDA recommends you take the following steps:

  • Check the expiration date printed on the packaging components to determine the new expiration date. If your facility has purchased Sterrad Cyclesure 24 Biological Indicators and product remains on hand, a new expiration date can be calculated as follows:

    [Printed Expiration date (minus) 9 months = new expiration date].

    For example, if the expiration date printed on packaging components is “2013-02,” then after subtracting 9 months, the new expiration date will be “2012-05.”

    For more information on how to determine new expiration dates on existing product inventory, please see ASP’s Recall Alert.

  • Manually re-label the non-expired product cases with the newly calculated expiration date. Until you receive correctly-labeled product, continue to calculate new expiration dates and manually label product that has not reached a 6 month shelf life with the newly-calculated expiration date.

  • According to ASP, a limited supply of new product with correctly-labeled expiration dates will become available the week of July 9, 2012. Product with correct labeling will have an eight digit lot number, compared to the six digit lot number on current product.

  • Use an alternative low-temperature sterilizer, if available. In order to conserve the amount of non-expired product available in your facility, only use low-temperature sterilization for those items that cannot be sterilized using other methods.

If your facility has lot numbers of the Sterrad Cyclesure 24 Biological Indicators that are not on the list provided by ASP, then your facility should contact ASP directly, at the phone number below, to inquire about the return of the product.

The FDA is working with ASP to evaluate appropriate data that will support the expiration dates for these biological indicators so that they continue to be available for safe use by hospitals and other health care facilities.

If you suspect a problem with the Sterrad Cyclesure 24 Biological Indicators, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.