Events

Recall of TRIVEX SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC. ENDOSCOPY DIVISION.

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
    152409
  • Event Risk Class
    II
  • Event Initiated Date
    2006-07-13
  • 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 sterility seal of some packaged trays may have gaps thereby compromising product sterility.

Device

TRIVEX SYSTEM
  • Model / Serial
    Model Catalog: 7209514 (Lot serial: 50165371 AND LOWER); Model Catalog: 7205876 (Lot serial: 50156094 AND LOWER); Model Catalog: 7209514 (Lot serial: 50156094 AND LOWER); Model Catalog: 7205961 (Lot serial: 50151697 AND LOWER); Model Catalog: 7205876 (Lot serial: 50165371 AND LOWER); Model Catalog: 7209983 (Lot serial: 50170383 AND LOWER); Model Catalog: 7209700 (Lot serial: 50170383 AND LOWER); Model Catalog: 7209855 (Lot serial: 50170383 AND LOWER); Model Catalog: 7209983 (Lot serial: 50164304 AND LOWER); Model Catalog: 7209855 (Lot serial: 50169658 AND LOWER); Model Catalog: 7209855 (Lot serial: 50164304 AND LOWER); Model Catalog: 7209983 (Lot serial: 50169658 AND LOWER); Model Catalog: 7209700 (Lot serial: 50169658 AND LOWER); Model Catalog: 7209700 (Lot serial: 50164304 AND LOWER)
  • Product Description
    TRIVEX RESECTOR KIT
  • Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIVISION

Manufacturer

SMITH & NEPHEW INC. ENDOSCOPY DIVISION
  • Manufacturer Address
    ANDOVER
  • Source
    HC