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
    19689
  • Event Risk Class
    II
  • Event Initiated Date
    2003-03-20
  • 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 connect adapter may not securely attach to the re-designed olympus bronchoscopes and may come loose during the sterile processing cycle.

Device

STERIS SYSTEM 1 - QUICK CONNECT KITS
  • Model / Serial
    Model Catalog: QXCXXXX (Lot serial: QLC1473 LOT 3147303 & BEFORE); Model Catalog: C14XX (Lot serial: QLC1473 LOT 3147303 & BEFORE); Model Catalog: QXCXXXX (Lot serial: C1473 LOT 3147303 AND BEFORE); Model Catalog: C14XX (Lot serial: C1406 LOT 3508686 AND BEFORE); Model Catalog: QXCXXXX (Lot serial: QLC1406 LOT 3508686 & BEFORE); Model Catalog: C14XX (Lot serial: QLC1406 LOT 3508686 & BEFORE); Model Catalog: QXCXXXX (Lot serial: C1406 LOT 3508686 AND BEFORE); Model Catalog: C14XX (Lot serial: C1473 LOT 3147303 AND BEFORE)
  • Product Description
    STERIS QUICK CONNECT KITS
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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