Medical device manufacturer, Advanced Sterilization Products (ASP) (a Johnson & Johnson company) has issued a field safety notice concerning STERRAD Booster with the Olympus CYF-V2 and CYF-V2R when processing in the STERRAD 100S and STERRAD 200 systems.
Previously, the use of a STERRAD Booster for these models was not required. Upon joint review of the construction of these endoscopes, ASP and Olympus Corporation decided a STERRAD Booster is required because the "effective" length of the channels slightly exceeds the 500mm threshold. The construction of these endoscopes has not changed.
Endoscopes with lumen specifications that exceed a length of 500mm require a STERRAD Booster for STERRAD 100S and STERRAD 200 systems when used outside of the US.
ASP has determined that the risk to a patient due to processing the Olympus endoscope models CYF-V2 and CYF-V2R without a Booster is extremely low.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 9 April 2013