Medical device manufacturer, Advanced Sterilization Products, has issued a medical device safety alert concerning its CIDEX OPA Solution. The affected product code numbers are 20391 and 20490.
The manufacturer conducted a post-market surveillance review of two international complaints for anaphylaxis following medical procedures involving a device disinfected with CIDEX OPA Solution. Subsequent investigation identified the user failed to follow the rinsing instructions to remove residual CIDEX OPA Solution from the medical devices post-processing. Improper rinsing may result in the potential for anaphylaxis risk for patient populations beyond bladder cancer patients.
The manufacturer advises customers that they may keep their current inventory of CIDEX OPA Solution and continue to safely use the product in accordance with the instructions for use, which contain the rinsing instructions.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 19 August 2015