Events

Recall of DIEGO ELITE TUBESET

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

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
    26946
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-01
  • 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
    Manufacturer has identified compromises in sterile packaging that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. the breach may not be easily seen. manufacturer has not received any complaints of injury associated with compromised sterile packaging. however it is possible that use of non-sterile product may introduce microbes and increase the potential for postoperative infection.

Device

DIEGO ELITE TUBESET
  • Model / Serial
    Model Catalog: TS100S (Lot serial: > 10 lot numbers contact mfg); Model Catalog: TS101DC (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    DIEGO ELITE TUBESET
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.