FDA TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T98-17 Print Media: 301-827-6242 April 2, 1998 Broadcast Media: 301-827-3434 Consumer Inquiries: 800-532-4440
FDA ISSUES A NATIONWIDE WARNING AGAINST THE USE OF “ABTOX” PLAZLYTE STERILIZATION SYSTEM
FDA is warning hospitals and physicians against the use of the Abtox Plazlyte Sterilization System, because FDA is aware of at least 10 injuries associated with ophthalmic surgical instruments which 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, Ill. 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 notified each of the 155 institutions, numerous foreign accounts and individuals who received these unapproved sterilization systems about the recall.
Users of these systems should be aware of the following:
- Do not use the AbTox Plazlyte Sterilization system to sterilize ophthalmic instruments;
- Verify that ophthalmic devices in inventory were not previously sterilized with this system;
- Do not sterilize any equipment and/or devices which may have been soldered or may contain brass, copper or zinc components; and
- Do not process any equipment and/or devices in containers which may have been soldered or contain brass, copper or zinc components.
FDA will actively monitor the progress of this recall and will take whatever appropriate action is needed to assure its successful completion.