FDA
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T98-17 Print Media: 301-827-6242
April 2, 1998
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.
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