Events

Recall of STERILE INTERMEDIARY TUBING (WITH CHECK VALVE)

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
    51435
  • Event Risk Class
    I
  • Event Initiated Date
    2013-09-04
  • 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
    Internal testing has found that the check valve (pillow valve) included in the fms (fluid management system) intermediary tubing set may not be performing as intended. if the controls described in the operator's manual are not followed this defect may result in backflow of irrigation fluid into the one-day set which may potentially lead to patient cross-contamination.

Device

STERILE INTERMEDIARY TUBING (WITH CHECK VALVE)

Manufacturer

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