Events

Recall of STERIS SYSTEM 1 - QUICK CONNECT KITS

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
    87260
  • Event Risk Class
    II
  • Event Initiated Date
    2002-05-21
  • 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
    Some components of the kits may be clogged with glue thus preventing sterilant used in the steris system 1 from flowing through the endoscope being processed. this could result in an unsterile device.

Device

STERIS SYSTEM 1 - QUICK CONNECT KITS
  • Model / Serial
    Model Catalog: C16XX (Lot serial: 200734); Model Catalog: C14XX (Lot serial: C1403); Model Catalog: C16XX (Lot serial: 200648); Model Catalog: C14XX (Lot serial: 200648); Model Catalog: C16XX (Lot serial: 200595); Model Catalog: C14XX (Lot serial: 200595); Model Catalog: C16XX (Lot serial: 200593); Model Catalog: C14XX (Lot serial: 200593); Model Catalog: C16XX (Lot serial: 200586); Model Catalog: C14XX (Lot serial: 200586); Model Catalog: C16XX (Lot serial: 200584); Model Catalog: C14XX (Lot serial: 200584); Model Catalog: C16XX (Lot serial: 200588); Model Catalog: C14XX (Lot serial: 200588); Model Catalog: C16XX (Lot serial: 200450); Model Catalog: C14XX (Lot serial: 200450); Model Catalog: C16XX (Lot serial: 200364); Model Catalog: C14XX (Lot serial: 200364); Model Catalog: C16XX (Lot serial: 200244); Model Catalog: C14XX (Lot serial: 200244); Model Catalog: C16XX (Lot serial: 200325); Model Catalog: C14XX (Lot serial: 200325); Model Catalog: C16XX (Lot serial: 200324); Model Catalog: C14XX (Lot serial: 2
  • Product Description
    QUICK CONNECT KITS AND COMPONENTS
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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