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 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
    93011
  • Event Risk Class
    III
  • Event Initiated Date
    2015-12-18
  • 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
    Quick connects provide directed flow of processing fluids (sterilant use dilution and rinse water) into the internal lumens of specifically identified endoscopes via adapters which connect to the endoscope ports. each quick connect contains a flow unit consisting of tubing tethers and adapters for connecting the medical device to the system 1 express processing tray to achieve liquid chemical sterilization. steris has learned that one of the hysteroscope models (karl storz 11264bbu1) listed for processing in two existing quick connects has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions. a user who connects the karl storz 11264bbu1 hysteroscope according to the processing instructions will observe an unused port adapter on the quick connect.

Device

SYSTEM 1 EXPRESS - QUICK CONNECT KIT
  • Model / Serial
    Model Catalog: QKC1736INT (Lot serial: all lots); Model Catalog: QKC1737INT (Lot serial: all lots)
  • Product Description
    SYSTEM 1 EXPRESS - QUICK CONNECT KIT
  • Manufacturer
    STERIS CANADA CORPORATION

Manufacturer

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