Medical device manufacturer, Advanced Sterilization Products, has issued a medical device safety alert concerning its STERRAD Systems [Models: 50, 100S, 200, 100NX and NX].

The manufacturer recently determined, as part of its routine quality programme that the leak indicator on the STERRAD System cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. STERRAD System cassette packaging assemblies are designed with a leak indicator on the inner package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes.

The manufacturer's recommendations on exercising extra precaution when handling new STERRAD System Cassettes are as follows:

• The customer should wear personal protective equipment (e.g. gloves) when handling the cassette. This is a precautionary measure in the event that the customer comes in contact with hydrogen peroxide.
• In addition to wearing personal protective equipment, the customer should perform a visual inspection of the cassette package to look for signs of liquid leakage prior to opening the package. If a liquid leak is observed, the customer should dispose of the cassette package immediately and contact the local supplier.
• If customers come into contact with hydrogen peroxide, they should immediately flush the affected area with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Medical attention should be sought promptly if symptoms occur after washing. Contaminated clothing should be washed before reuse.

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 27 November 2014