Events

Recall of PRISMAFLEX HEMODIALYSIS UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO LUNDIA AB.

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
    107084
  • Event Risk Class
    I
  • Event Initiated Date
    2007-07-27
  • 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
    For 10-20-30ml heparin syringe carrier:new instructions on how to correctly load syringe in new heparin syringe carrier.If not followed a risk of negative pressure exist with the potential for overdelivery.

Device

PRISMAFLEX HEMODIALYSIS UNIT

Manufacturer

GAMBRO LUNDIA AB