ASP Recalls Sterrad Biological Indicators

Advanced Sterilization Products (ASP) is voluntarily recalling its Sterrad Cyclesure 24 Biological Indicators due to expiration dates that are past the product's useful life.

According to ASP's recall letter, a recent FDA review of the company's data found that the indicators may not be effective throughout their entire 15-month shelf life. In fact, their use past 6 months may not deliver accurate results in monitoring the Sterrad low-temperature sterilizer.

While the FDA suggests that the risk to patients is low, facilities that use the Sterrad system and the Cyclesure 24 indicators are advised to:

• check the expiration dates on your supply of the product;
• calculate the new, correct expiration date by subtracting 9 months or consulting the recall letter; and
• return expired product to ASP or manually re-label unexpired product.

ASP and the FDA note that users may experience temporary shortages of the indicators while the product is re-dated. They recommend that in order to conserve the amount of non-expired product on hand, facilities use low-temperature sterilization only for items that can't be sterilized through other methods, and to use alternatives to the Sterrad system.

Users are asked to report any problems they witness to the FDA's MedWatch program, and to direct any additional questions to ASP at (877) 907-7030 or through their local representative.

David Bernard