Replay of FDA teleconference on sterilizer product recall available

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The Food and Drug Administration yesterday held an informational teleconference on the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems. A replay of the call will be available until Aug. 5 by dialing (866) 428-3805. On Tuesday, Advanced Sterilization Products voluntary recalled its Sterrad Cyclesure 24 Biological Indicator after an FDA review showed that the product cannot effectively monitor the sterilization process throughout its stated 15-month shelf life. FDA recommends that hospitals and other health care facilities determine the new expiration date by subtracting nine months from the expiration date printed on the product's packaging; manually re-label non-expired product cases with the new expiration date; return outdated product as instructed in the ASP recall alert; and use an appropriate alternative sterilizer if available. In an update today, FDA confirmed that only lot numbers listed in the ASP recall alert are affected by the recall. notice.