Events

Recall of Device Recall Tabletop Steam Sterilizers.

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

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
    25727
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-03
  • Event Initiated Date
    2003-03-05
  • Event Date Posted
    2003-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26376
  • 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
    The pressure relief valve may fail to open properly.
  • Action
    The firm notified their customers by telephone on 3/5/2003.

Device

Device Recall Tabletop Steam Sterilizers.
  • Model / Serial
    Models: M7-011 and M7-014; Serial Numbers: MH006260 to MH006269, MH006273, MH006277 to MH006282, MH006284 to MH006290, MH006294, ML007606 to ML007608, ML007610, ML007637 to ML007642.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were shipped to distributors and medical facilities located in: ME, IL, CA, VA, MA, MO, AZ, OH, IN, NH, and FL. The units were also distributed into Canada.
  • Product Description
    Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.
  • Manufacturer
    Midmark Corp

Manufacturer

Midmark Corp
  • Manufacturer Address
    Midmark Corp, 60 Vista Dr, PO Box 286, Versailles OH 45380
  • Source
    USFDA