Events

Recall of TEFLON TUBE - STERILE

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
    25345
  • Event Risk Class
    I
  • Event Initiated Date
    2013-11-04
  • 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 has discovered that there is potential for the product to be non-sterile. it was reported that there was a potential failure during routine maintenance of the sealing machine and it is likely to have caused unsuitable cross seals on the outer pouch. it was reported that there is potential for an unsterile inner pouch of the teflon tube due to missing seal integrity.

Device

TEFLON TUBE - STERILE
  • Model / Serial
    Model Catalog: 1806-0073S (Lot serial: K05ECF3); Model Catalog: 1806-0073S (Lot serial: K0432D3); Model Catalog: 1806-0073S (Lot serial: K057298); Model Catalog: 1806-0073S (Lot serial: K05ECF2)
  • Product Classification
    Orthopedic Devices
  • Product Description
    TEFLON TUBE - STERILE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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