Events

Recall of Device Recall 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 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
    58290
  • Event Risk Class
    Class 2
  • Event Number
    Z-1960-2011
  • Event Initiated Date
    2011-03-14
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98904
  • 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 printout, display and operator manual for the steris system 1e liquid chemical sterilant processing system are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and operator manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco.
  • Action
    The firm, STERIS, Issued an 'Urgent Field Correction Notice' dated March 14, 2011 addressed to their Hospital Administrator, or Manager, and Risk Manager customers on March 18, 2011. The notification letter describes the product subject to field correction and the problem that exists with the language omission present in the printout display and Operator Manual messages which warn of an incomplete or aborted processing cycle. The notification goes on to state that there is no health hazard involved in this error, as the users are still made aware that the processing cycle has not been successfully completed. The notification goes on to remind the user/customers that in case of any incomplete, cancelled or aborted cycle, the users are instructed to process devices in the cycle following the directions contained in the Operator Manual. Lastly, the notification letter informs the user/customers that the company will be installing new software on the recalled systems in order to revise the language on the cycle printout and the display screen warning of a disrupted cycle. It also states that a STERIS Service Representative will be contacting each facility in order to schedule installation of the new software. The notification also provides the customers with a 1-800 telephone number for STERIS Field Service Dispatch, to be used if the customers have questions or want to request additional information. It also provides a local telephone no. 1-440-392-7455, for obtaining additional information from the firm's Director, Div. of Low Temperature Sterilization at: 1-440-392-7455.

Device

Device Recall SYSTEM 1E liquid chemical sterilant processing system
  • Model / Serial
    All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.
  • Product Description
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System || The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
  • 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