Medical device manufacturer, Advanced Sterilization Products, has issued a medical device safety alert concerning its CIDEX Activated Glutaraldehyde Solution.
The manufacturer recently determined, as part of its routine quality program, that it may lack the adequate data to support the entire 24-month shelf life of CIDEX Activated Glutaraldehyde Solution. The manufacturer determined that data for CIDEX Activated Glutaraldehyde Solution supports a 12-month shelf life. The CIDEX Activated Glutaraldehyde Solution is currently labeled for a 24-month shelf life.
While the product has a maximum 14-day reuse life, data shows that the pH level of the CIDEX Activated Glutaraldehyde Solution may be below specification for up to 2 hours after activation. Use of CIDEX Activated Glutaraldehyde Solution after 12 months may result in inadequate medical device reprocessing (disinfection/sterilization) or re-contamination if it is used for reprocessing within the first 2 hours of activation.
The manufacturer advises users to check the expiration date on all bottles of CIDEX Activated Glutaraldehyde Solution currently in inventory.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 August 2015