Medical device manufacturer, Advanced Sterilization Products (ASP), has issued a field safety notice concerning STERRAD 100NX System cassettes.
ASP recently determined, as part of its routine quality program, that it does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100NX System cassette's 15-month shelf life. ASP has determined that data for the leak indicator is effective for only 12 months of the cassette's 15-month shelf life.
The likelihood of a leak is extremely low, and there have been no reported cases of a leak where the indicator was not effective in identifying the leak. The cassette itself is fully functional and there is no compromise to the efficacy of the cassette or to sterilization process as there is data to support the cassette's 15-month shelf life.
ASP plans to update the shelf life of affected products. In the meantime, until the above change takes effect, customers are advised to check the expiration date on all affected products and follow the advice related to exercising extra precaution on handling hazardous materials as mentioned in the field safety notice. Alternatively, the concerned product can be returned to the manufacturer to have the shelf life of the affected products to be consistent with the leak indicator.
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 1 August 2013