Events

Recall of CODMAN EDS3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    48389
  • Event Risk Class
    I
  • Event Initiated Date
    2014-09-19
  • 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
    A recall of all lots of eds 3 csf external drainage systems with an expiration on or before august 2017 is being conducted because the tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over or under-drainage of csf from the ventricular system or introduction of air into the ventricular system or an increased risk of ventriculitis.

Device

CODMAN EDS3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER KIT

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.