Events

Recall of The SYSTEM 1E Liquid Sterilant Processing System.

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
    62895
  • Event Risk Class
    Class 2
  • Event Number
    Z-2335-2012
  • Event Initiated Date
    2012-08-01
  • Event Date Posted
    2012-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111958
  • 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
    Sterilant Medical Devices - Product Code MED
  • Reason
    The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
  • Action
    STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

The SYSTEM 1E Liquid Sterilant Processing System.
  • Model / Serial
    Model #: P6500, S/N 400000 through 406294
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
  • Product Description
    The SYSTEM 1E Liquid Sterilant Processing System. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • 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