Medical device manufacturer, Kerr Corporation, has issued a medical device safety alert concerning AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS. They found that the current instructions for Use (IFUs) for AlgiNot include product specifications and instructions that are not indicative of the actual performance of the product. The IFUs incorrectly state the work time/mouth removal time.
According to the local supplier, the affected devices were distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 27 June 2012