Events

Recall of GUIDING CATHETER STRAITGUT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by YOCAN MEDICAL SYSTEMS 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
    51707
  • Event Risk Class
    II
  • Event Initiated Date
    2000-05-18
  • 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
    Premature aging of the raw material and due to a weakness in the polyethylene material the tip of the catheter may break off or the hub may split from the device.

Device

GUIDING CATHETER STRAITGUT
  • Model / Serial
    Model Catalog: GC 6/95CM (Lot serial: 712173MA 602264MA 702231MA); Model Catalog: GC 5/95CM (Lot serial: 712173MA 602264MA 702231MA); Model Catalog: GCA 9/6 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 8/5 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 7/5 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 9/6 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 8/5 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 7/5 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 9/6 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 8/5 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 7/5 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 9/6 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 8/5 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 7/5 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 9/6 (Lot serial: 505124M 10044161A 810211MA); Model Catalog: GCA 8/5 (Lot serial: 505124M 10044161A 810211MA); Model Catalog: GCA 7/
  • Product Description
    GUIDING CATHETERS
  • Manufacturer
    YOCAN MEDICAL SYSTEMS INC.

Manufacturer

YOCAN MEDICAL SYSTEMS INC.