Events

Recall of Device Recall Steris Small Renaissance Eagle 3000.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris 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
    48999
  • Event Risk Class
    Class 2
  • Event Number
    Z-2350-2008
  • Event Initiated Date
    2008-03-06
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72493
  • 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
    Steam sterilizer - Product Code FLE
  • Reason
    The firm discovered that some eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. the sterilizer is designed with switches that prevent cycle initiation if the door is not locked. however, in the event the door switches are not properly adjusted they may falsely indicate that the door is locked even t.
  • Action
    On March 5, 2008, Steris issued an Urgent Product Correction. Beginning March 6, 2008 customers were notified by telephone. The firm instructed their customers to immediately discontinue using the small Renaissance Eagle 3000 steam sterilizer(s) until inspected and corrected by a service technician. Steris Service technicians were dispatched to affected customers to inspect and correct the sterilizers as appropriate. If you have any questions contact Holly Wright Lee at (404) 392-7019 or 1-800-548-4873 ext. 27019.

Device

Device Recall Steris Small Renaissance Eagle 3000.
  • Model / Serial
    Gravity Models 3011 & 3021 and Prevaccuum Models 3013 and 3023.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, and WY, and countries of Canada and Mexico.
  • Product Description
    Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060-1834
  • Source
    USFDA