A customer reported they have been using expired cyclesure 24 biological indicators (bis) through the month of (b)(6) 2015.The bis were used in loads processed from (b)(6) 2015.According to sterrad cycle parameter readouts all cycles passed.The chemical indicator (ci) disc on each bi changed color correctly.No positive media results were reported with any processed bi.All affected loads were released for use on patients.There was no report of infection, injury or harm to patients associated with this issue.Although there is no report of patient injury or harm, advanced sterilization products (asp) has determined in this situation sterility cannot be assured as the product used was expired.
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(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, and system risk analysis (sra).¿ the dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.¿ trending analysis by lot number was reviewed from 04/23/2015 to 10/23/2015 and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the expired cyclesure® bis were not returned for evaluation.There is no allegation of product failure as the customer used expired product.The assignable cause was user error.There was no functional issue reported with the cyclesure® bi.A customer letter will be sent addressing the applicable section of the instructions for use.This issue will continue to be tracked and trended.
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