Events

Recall of STERILIZATION TRAY

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

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
    134888
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-25
  • 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
    Stryker endoscopy has discovered that worst-case sterilization testing was not conducted when the products were initially tested and released. the gravity sterilization parameters have been revised in the instructions for use (ifu) for the above affected products. the sterilization time has been increased in order to comply with sterility assurance requirements.

Device

STERILIZATION TRAY
  • Model / Serial
    Model Catalog: 0233-032-890 (Lot serial: ALL); Model Catalog: 0502-880-330 (Lot serial: ALL); Model Catalog: 0502-880-430 (Lot serial: ALL); Model Catalog: 3910-500-721 (Lot serial: ALL)
  • Product Description
    STERILIZATION TRAY
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC