Recall of RELIANCE 130/130L CART AND UTENSIL WASHER/DISINFECTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA 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
    31151
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-13
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The reliance 130 and 130l cart washer/disinfector is a high capacity mechanical washer intended for use in the washing low-level disinfecting and drying of carts utensils beds and other miscellaneous reusable items used in the care of patients at healthcare facilities. in review of the reported events steris has learned users are not always familiar with the intended function of the door open/close commands and the washer's safety features. to ensure users are properly operating the reliance 130 and 130 l cart washer a "door close" confirmation button and door open delay will be installed ont the cart washer (s).

Device

  • Model / Serial
    Model Catalog: FW01-XXX (Lot serial: 3606499005 to 3628809011); Model Catalog: FW02-XXX (Lot serial: 3606499005 to 3628809011)
  • Product Description
    RELIANCE 130 and 130L CART WASHER
  • Manufacturer

Manufacturer

  • Manufacturer Address
    QUEBEC
  • Manufacturer Parent Company (2017)
  • Source
    HC