Events

Recall of NEWTON IQ DIALYSIS CYCLER SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FRESENIUS MEDICAL CARE 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
    109795
  • Event Risk Class
    I
  • Event Initiated Date
    2006-04-20
  • 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
    Since 2006/03/07 fersenius medical care in the us has received 69 complaints which allege that patients could not thread/connect the stay safe patient connectors (trigger) to their pd transfer extension sets.

Device

NEWTON IQ DIALYSIS CYCLER SET

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.