Midmark and Ritter M11 UltraClave® Automatic Sterilizer
Recall and Field Correction Plan (January 11, 2012)
With regard to the M11 recall on December 28, 2011, Midmark is working with the FDA to ensure that field correction activities are implemented to their satisfaction. We are committed to ensure compliance with all applicable laws and regulations.
Customers will be contacted by mail and provided with a warning label to place on M11 units manufactured between 1994 through 2003. Midmark is taking this action after receiving reports that a very small percentage of end-users were not properly closing the door before operating the unit.
If you have any questions, please call 1-800-531-3309.
Because we care.