Events

Recall of Device Recall Reliance 1227

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
    68696
  • Event Risk Class
    Class 3
  • Event Number
    Z-2036-2014
  • Event Initiated Date
    2014-06-30
  • Event Date Posted
    2014-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128461
  • 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
    Disinfector, medical devices - Product Code MEC
  • Reason
    Steris has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.
  • Action
    Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion.

Device

Device Recall Reliance 1227
  • Model / Serial
    Serial Number Range: 3632511020 - 3613214010
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.
  • Product Description
    Reliance 1227 Cart and Utensil Washer/Disinfector || Product Usage: Usage: || The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
  • 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