Events

Recall of POLYFLUX REVACLEAR

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

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
    148834
  • Event Risk Class
    I
  • Event Initiated Date
    2016-10-05
  • 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
    Baxter corporation is issuing a voluntary product recall for one (1) lot of revaclear max dialyzers due to the potential presence of particulate matter within the blood side of the dialyzer. the issue was identified as a result of one customer complaint received for the presence of black fibers and dust within the dialyzer. there is the potential of visually not detecting the presence of foreign material in the blood side of the dialyzer. when the dialyzer is used the particles may become dislodged by flow of the dialysate and may reach the vascular system of the patient which could lead to adverse health consequences. there have been no reports of injuries associated with this issue.

Device

POLYFLUX REVACLEAR

Manufacturer

BAXTER CORPORATION