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"ABTOX" MONITORED BY THE FDA

On April 2, 1998 the FDA warned hospitals and physicians against the use of the Abtox Sterilization System.  Serious cornea injuries and damage to vision requiring corneal transplantation were the eminent reasons for the recall.

The manufacturer, Abtox, Inc, of Mundelein, Ill, has initiated a worldwide recall for this model of device.  This device was never cleared by USFDA. 

Toxic salt from the chemical sterilants form when the device is used on surgical tools made of copper, brass or zinc.

Users of these systems should be aware of the following:

• Do not use the AbTox Sterilization system to sterilize ophthalmic instruments;
• Verify that ophthalmic devices in inventory were never sterilized with this system;
• Never sterilize any equipment and/or devices which may have been soldered or may contain brass, copper or zinc; and

• Never process any equipment and/or devices in containers which may have been soldered or contain brass, copper or zinc.

The United States Food and Drug Administration will carefully monitor the progress of this recall and will take the appropriate action if needed to assure its successful completion. 

For more information contact the U.S. Department of health and Human Services, division, The U.S. Food and Drug Administration.

-Scott Neff MSOM DC IME CFE CFMFE FFAAJTS