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Food and Drug Administration

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  • Food and Drug Administration

    U.S. Food and Drug Administration

    Protecting and Promoting Your Health

  • #2
    This report shows how important routine maintenance is for autoclaves. The owner of this machine reported these issues to the FDA. It is important to note that this unit was 9 years old at the time of reporting.
    Under normal use (ACRA) the manufacturer of the heating elements was stating a 4 year life to these heaters under normal use (assuming about 5,000 cycles in this period).

    Tuttnauer did issue a recall on the door closing devise for unit manufactured in I think it was a nine month period of manufacture in 1993. Had the customer been having routine maintenance on this machine the closing device should have been noticed and replaced under the recall. I'm pretty sure that Tuttnauer was still covering this repair in 2001. I can check my own records.

    Also, with the design of this device I am extremely skeptical of the report.

    Routine Maintenance is important!


    • #3
      510(K) Summary for Tuttnauer EZ Plus series autoclaves.