Events

Recall of AK 98

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
    62613
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-08
  • 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 an urgent device correction for the ak 98 hemodialysis machines listed below. baxter has identified that an incorrect cable was installed in the affected ak 98 machines. if the user connects the machines to the ethernet network a leakage of currents higher than specified values may occur. these units do not have and are not intended to have ethernet functionality. baxter will be correcting the affected units by providing a cap for the ethernet connectors to block the connection.

Device

AK 98
  • Model / Serial
    Model Catalog: 115251 (Lot serial: Serial numbers 13320 and lower)
  • Product Description
    AK 98 DIALYSIS MACHINE
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION