Events

Recall of PRELOADED OMNITOME

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    18609
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-28
  • 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 wire guide in the fusion omni-tome pre loaded sphincterotome being loaded incorrectly into the device resulting in the incorrect end of the wire guide exiting the sphincterotome. the preloaded wire guide has a black floppy distal tip which could be located at the proximal/user end and leaving the stiff end of the wire guide at the distal/patient end of the sphincterotome. difficulty advancing the wire guide may be experienced.

Device

PRELOADED OMNITOME
  • Model / Serial
    Model Catalog: FS-OMNI-35-260 (Lot serial: W3495807)
  • Product Description
    FUSION OMNI TOME PRELOADED SPHINCTEROTOME
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.