Events

Recall of DIALOG+ DIALYSIS MACHINES - SINGLE PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHIEF MEDICAL SUPPLIES LTD..

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
    151451
  • Event Risk Class
    I
  • Event Initiated Date
    2016-03-17
  • 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
    Flanges assembled into conductivity cells show hairline cracks. if a crack occurs it may lead to a leakage and result in a balance deviation. affected machines will have improper filtration rate.

Device

DIALOG+ DIALYSIS MACHINES - SINGLE PUMP
  • Model / Serial
    Model Catalog: 710200C (Lot serial: >10 numbers contact mfg); Model Catalog: 710200CV (Lot serial: >10 numbers contact mfg); Model Catalog: 710200CV (Lot serial: >10 numbers Contact Mnf); Model Catalog: 710201S (Lot serial: >10 numbers contact mfg); Model Catalog: 7102072 (Lot serial: >10 numbers contact mfg); Model Catalog: 710200C (Lot serial: >10 numbers Contact Mnf); Model Catalog: 710201S (Lot serial: >10 numbers Contact Mnf); Model Catalog: 7102072 (Lot serial: >10 numbers Contact Mnf)
  • Product Description
    Dialog+ Dialysis Machines
  • Manufacturer
    CHIEF MEDICAL SUPPLIES LTD.

Manufacturer

CHIEF MEDICAL SUPPLIES LTD.