Events

Recall of Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm

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

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
    60742
  • Event Risk Class
    Class 2
  • Event Number
    Z-0869-2012
  • Event Initiated Date
    2011-12-07
  • Event Date Posted
    2012-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106373
  • 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
    Software deficiency. steris identified that water specifications were not being met at some of their customer sites. critical parameters for initiating cycles are: water quality, water pressure and water temperature. failure to meet these criteriae may lead to cycle aborts by the system 1e liquid chemical sterilant processing system. the firm intends to perform a software field correction which.
  • Action
    The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM ¿¿ Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.

Device

Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm
  • Model / Serial
    MED. Serial Numbers: 400000 through 405499 are subject to correction.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
  • Product Description
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer
    Steris Corporation Hopkins Facility

Manufacturer

Steris Corporation Hopkins Facility
  • Manufacturer Address
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA