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).
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.
Hospitals and health care facilities should check their inventory for Sterrad Cyclesure 24 Biological Indicators that have exceeded 6 months of shelf life. These products should be returned to ASP immediately, as outlined in ASP’s product return instructions.
If your ASC uses Sterrad Cyclesure 24 Biological Indicators, click here for an FDA checklist of the steps you need to take.
Should you have additional questions, please contact Stericycle at 1-877-907-7030 or contact your ASP representative. Stericycle’s hours of operation are Monday-Friday, 8 a.m.-5 p.m. ET.
If you would like listen to a replay of the July 5th FDA Stakeholder Teleconference regarding this product, dial 866-428-3805. This call will be available until Aug. 5, 2012.