Events

Recall of TEGAGEL WOUND FILLER AND GAUZE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M CANADA COMPANY.

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
    42864
  • Event Risk Class
    III
  • Event Initiated Date
    2001-10-25
  • 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
    The product has been misbranded in that the filling tubes for tegagel hydrogel wound filler were filled with a hollister restore hydrogel.

Device

TEGAGEL WOUND FILLER AND GAUZE
  • Model / Serial
    Model Catalog: 90412 (Lot serial: 6104101)
  • Product Description
    3M TEGAGEL HYDROGEL WOUND FILLER
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

3M CANADA COMPANY
  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    HC