Events

Recall of RELIANCE ENDOSCOPE PROCESSOR

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
    117703
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-12
  • Event Country
    Canada
  • 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 endoscope processing system (reps) is intended for washing and high level disinfection of up to two manually pre-cleaned immersible reusable heat-resistantsemi-critical devices such as gi flexible endoscopes bronchoscopes and their accessories. steris corporation is providing an urgent product safety notice to inform affected customers of an important change in the reliance endoscope processing system instructions for use when processing fujinon g5 and g8 type flexible gi endoscopes. this notice excludes fujinon model ec-530h l and ec-530ls gi endoscopes and does not affect use of the reliance eps to process any other manufacturer's qualified endoscopes.

Device

RELIANCE ENDOSCOPE PROCESSOR
  • Model / Serial
    Model Catalog: MB3-XXXX (Lot serial: S/N: 3625606001-3608912002); Model Catalog: MB00-XXXX (Lot serial: S/N: 3625606001-3608912002)
  • Product Description
    RELIANCE ENDOSCOPE PROCESSOR
  • Manufacturer
    STERIS CANADA CORPORATION

Manufacturer

STERIS CANADA CORPORATION
  • Manufacturer Address
    QUEBEC
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC