Field Correction

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.

Important notice for M11s manufactured before 5/29/2003:

Model numbers affected:
M11-001; M11-001R; M11-002; M11-002R; M11-003; M11-004; M11-005; M11-006; M11D-001; M11D-002

If you purchased a Midmark or Ritter M11 that was built prior to 5/29/2003, your sterilizer may be subject to a field correction initiated 1/11/2012. If your model matches one of the model numbers listed above, fill out the information below to receive a notification letter with detailed instructions, technical service bulletin and warning label, which you simply apply to your sterilizer.

If the model number does not match one from the list above, your sterilizer is not affected by the recall.

Register here for automatic product updates.

Take a Simple Step in Your Office to Ensure Effective Use of the M11 Sterilizer

As soon as you receive the warning label, you will simply apply it to the area adjacent to the M11 door handle
as indicated above. The label will serve as a reminder to follow correct instructions, ensuring that the door is
properly latched in the closed position before operating.

Once you have applied the label to your M11 unit, please click here, go to midmark.com/FCAResponse
or call 1-800-531-3309.