Events

Recall of TITANIUM BOBBIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC 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
    26689
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-02
  • 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
    Boxes of 510-101 lot 53226 and 500-101 lot 53240 were packaged at the same time during final packaging. final packaging consists of placing sealed sterile pouched tubes in boxes and labeling the boxes. some of the final packed boxes had a mixture of these two tubes. all pouches were packaged and labeled correctly.

Device

TITANIUM BOBBIN
  • Model / Serial
    Model Catalog: 500-101 (Lot serial: 53240); Model Catalog: 53226 (Lot serial: 53226)
  • Product Description
    Reuter Bobbin Vent Tubes;T-Tubes
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.