Events

Recall of Device Recall Evolution steam sterilizers

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

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
    61786
  • Event Risk Class
    Class 2
  • Event Number
    Z-1522-2012
  • Event Initiated Date
    2012-03-23
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109080
  • 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
    Through customer feedback and field service experience, steris learned that operators may experience difficulty when inserting or removing equipment from the evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) the rollers on the ends of the pivot a.
  • Action
    Steris Corporation sent an Urgent Voluntary Field Correction Notice dated March 23, 2012 via FedEx with tracking numbers for delivery confirmation to each affected customer. The letter identified the affected product, problem and actions to be taken. The letter stated a STERIS Field Service Representatives will contact each affected customer to schedule a service visit to upgrade the transfer carriages. For technical questions or questions regarding STERIS visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Device Recall Evolution steam sterilizers
  • Model / Serial
    Model #: M4012097, M4012098, M4011084, M4011085 & M4011090; Seral #s: 030400905 thru 030381235.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including AL, AZ, CA, CO, CN, DE, FL, GA, IL, IN, KA, KY, LA, MD, MA, MI, ME, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, & WY and the countries of Brazil and Canada.
  • Product Description
    The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: || -Loading Car: Shelving unit which holds the items to be sterilized; and the || -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. || Product Usage: || The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA