FDA Issues Warning on ABTOX Plazlyte Sterilization System

The U.S. Food and Drug Administration (FDA) issued a warning to hospitals and physicians against the use of the Abtox Plazlyte Sterilization System. FDA is aware of at least 10 injuries associated with ophthalmic surgical instruments that had been sterilized with this system. These reports involved serious injuries to the cornea with damage to vision, and at least two cases have required corneal transplantation.

The product's manufacturer, Abtox, Inc., of Mundelein, IL has initiated a worldwide recall for this model of device. This device has never been cleared by FDA.

The problem appears to be formation of toxic salt from the chemical sterilants when the device is used on surgical tools made of copper, brass or zinc.

The firm has sent recall notices to each of the 155 institutions, numerous foreign accounts and individuals who received these unapproved sterilization systems.

For more information, contact the FDA at 800-532-4440.