Events

Recall of SYSTEM 1 EXPRESS - QUICK CONNECT KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA INCORPORATED.

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
    124907
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-18
  • 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
    Qfc1716int is an accessory to the system 1 express sterile processing system. this quick connect consists of labeling and a flow unit made up of tubing tethers and adapters used for connecting ports of specified fujinon devices to flexible processing trays/containers placed within the system 1 express. steris has learned that the suction connector barb adapter on the qfc1716int does not properly fit the suction connector port of the fujinon 530 series endoscopes and consequently disconnects from the endoscope prior to reprocessing.

Device

SYSTEM 1 EXPRESS - QUICK CONNECT KIT
  • Model / Serial
    Model Catalog: QXCXXXXINT (Lot serial: 5984372); Model Catalog: QXCXXXXINT (Lot serial: 6134704)
  • Product Description
    SYSTEM 1 EXPRESS QUICK CONNECT (QFC1716INT)
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC