Events

Recall of PHILIPS BOUGIE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COLOPLAST MANUFACTURING US LLC.

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
    30486
  • Event Risk Class
    II
  • Event Initiated Date
    2009-01-23
  • 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
    One vigilance case & 2 complaints were received in 2008 in relation to the philips catheter 1 eye female metric thread. the metallic tip detached from the shaft upon or prior to using the device.

Device

PHILIPS BOUGIE
  • Model / Serial
    Model Catalog: AG55XX (Lot serial: ALL MFR BETWEEN 2003-2008)
  • Product Description
    philips bougie
  • Manufacturer
    COLOPLAST MANUFACTURING US LLC

Manufacturer

COLOPLAST MANUFACTURING US LLC
  • Manufacturer Address
    MINNEAPOLIS
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    HC