Events

Recall of Midmark M11 Ultra Steam Sterilizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Midmark Corportation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0597-2012
  • Event Initiated Date
    2011-10-24
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sterilizer, steam - Product Code FLE
  • Reason
    During and fda inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
  • Action
    Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275.

Device

Midmark M11 Ultra Steam Sterilizer
  • Model / Serial
    Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA (nationwide) including Puerto Rico and the countries of AUSTRALIA, BELGIUM, BRAZIL, CHILE, CHINA, EGYPT, FRANCE, GUAM, HONG KONG, HUNGARY, ICELAND, INDIA, KOREA, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, POLAND, RUSSIA, SAIPAN MP, SAUDI ARABIA, SEOUL, SINGAPORE, TAIWAN, THAILAND, TURKEY, U.A.E., UNITED KINGDOM and WEST INDIES.
  • Product Description
    Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. || Sterilize reusable equipment that is heat and moisture stable.
  • Manufacturer
    Midmark Corportation

Manufacturer

Midmark Corportation
  • Manufacturer Address
    Midmark Corportation, 60 Vista Dr, Versailles OH 45380
  • Manufacturer Parent Company (2017)
    Midmark Corporation
  • Source
    USFDA