The Food and Drug Administration on July 5 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 July 3, 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printed on the product's packaging; manually re-label non-expired product cases with the new expiration date; return outdated product as instructed in the ASP recall alert; and use an appropriate alternative sterilizer if available.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 on July 6, FDA confirmed that only lot numbers listed in the ASP recall alert are affected by the recall. For more information, see the FDA notice.
[ via AHA News Now ]
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