Events

Recall of SYSTEM 1E Liquid Chemical 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
    59752
  • Event Risk Class
    Class 2
  • Event Number
    Z-3124-2011
  • Event Initiated Date
    2011-08-11
  • Event Date Posted
    2011-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103574
  • 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, chemical - Product Code MLR
  • Reason
    Steris learned that system 1e users may experience aborted cycles due to a failure within the uv light system.
  • Action
    STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.

Device

SYSTEM 1E Liquid Chemical Sterilant Processing System
  • Model / Serial
    Model # P6500, S/N: 400001 through 405005
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Bahrain.
  • Product Description
    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. || Product Usage: The SYSTEM 1E Liquid Chemical 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
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA