Labeling changes provided to users of Abtox' Plazlyte sterilization system should be sufficient to address problems caused by devices sterilized by the system, the firm maintains.

After FDA raised concerns about the Abtox system, the Mundelein, Illinois-based firm issued a labeling recall March 31 advising customers not to use the system to sterilize ophthalmic instruments or any devices that may have been soldered or may contain brass, copper or zinc components, the company reports.

When used on surgical tools made of copper, brass or zinc, the system appears to cause a "formation of toxic salt from the chemical sterilants," FDA says in an April 2 "Talk Paper." Abtox does not believe that a change to the system's sterilants will be necessary. With its recall letter Abtox includes a revised page for the system's operator manual and instructs users to return the superseded pages.

The agency warns hospitals and physicians not to use the system because FDA "is aware of at least 10 injuries associated with ophthalmic surgical instruments" sterilized by the system. The reports involved "serious injuries to the cornea with damage to vision," requiring corneal transplantation in two cases, according to the agency.

In addition to encouraging customers not to sterilize ophthalmic instruments with the Plazlyte system, FDA advises users to verify that ophthalmic devices in inventory were not previously sterilized with the system.

Abtox' pending 510(k) for modifications to the system faces additional challenges in the wake of the recall. The company was cleared to market the low-temperature, gas plasma-based system in December 1994 ("The Gray Sheet" Jan. 9, 1995, In Brief). However, the firm never sold the approved device but instead began marketing a modified version, believing an additional 510(k) was not necessary to cover the changes.

Upon FDA's request, however, Abtox submitted a 510(k) to receive clearance for the modifications. The agency has returned previous versions of the premarket notification because they were deemed insufficient, according to agency staffers. The pending 510(k) was submitted to FDA in February, Abtox says.

Abtox Conducts Labeling Recall For Plazlyte Sterilization System

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