STERRAD CYCLESURE 24 Biological Indicators 의 안전성 경고

Safety alert

2013-04-26

2013-04-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426.html

Medical device safety alert: advanced sterilization products sterrad cyclesure 24 biological indicators medical device manufacturer, advanced sterilization products, has issued a field safety notice concerning sterrad cyclesure 24 biological indicators. the affected part number is 14324 and certain product lots manufactured in 2012 are affected. the manufacturer recently determined, as part of its routine quality program, which it may not have adequate data to support the entire duration of the labeled shelf-life of affected products. all affected products are currently expired as of march 2013 with no remaining shelf-life. in addition to being used as a standard method for frequent monitoring of sterrad system cycles, sterrad cyclesure 24 bis are also a component of validation kits used during the installation of sterrad systems. sterrad systems installed and validated between february 2012 and march 2013 may have used affected sterrad cyclesure 24 bi product. the validation process checked parameters and mechanical operations of the sterilizer that are not dependent upon the affected sterrad cyclesure 24 bi product. the risk of infection for an individual patient is low because the sterrad cyclesure 24 bi product is only one of three sterilization system monitors. however, use of affected sterrad cyclesure 24 bi product from the affected lots may have resulted in the inability to verify proper sterilization conditions. the manufacturer advises that: this is not a product removal as all affected sterrad cyclesure 24 bi product is expired with no remaining shelf life. users should not use expired sterrad cyclesure 24 bi product. if sterrad system was installed and validated between february 2012 and march 2013, the manufacturer can arrange an optional revalidation. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.