In a letter to MIDMARK, The FDA has cited a number of violations in the production of the M-11 Autoclave. This is a device that is in use in the offices of many doctors in private practice across the country. Most of the violations related to failure to keep adequate records of production of these Autoclaves. One specific item referenced involved failure to provide a timely report of a malfunction where the door of the autoclave blew off. The FDA letter states that this "would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur"
The full letter from the FDA to MIDMARK can be found at ( http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm28533... ).
Midmark President and CEO Dr. Anne Eiting Klamar issued a statement that MIDMARK “takes the issues raised by FDA extremely seriously,” The statement goes on to include “Midmark’s top priority is addressing FDA’s concerns and will take prompt actions to correct all violations.” Klamar said. “With regard to the M11 sterilizers produced before 2003, we were already working on resolving this issue before FDA audited our facility. Since the audit, we have begun working with FDA to ensure that our field correction activities are implemented to FDA’s satisfaction.”
If you have a M11 Sterilizer you may want to contact MIDMARK Directly ( http://www.midmark.com ) or 1-877-268-4489 |