Events

Recall of ULTRAFILTER U-9000

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
    24235
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-27
  • 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
    Baxter corporation is issuing an urgent medical device correction for the ultrafilter u9000 lot numbers listed below due to leaks during regular clinical use in conjunction with artis ak98 and ak96 dialysis machines. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. a leaking ultrafilter u9000 could lead to excessive fluid removal during dialysis and subsequently hypovolemia.

Device

ULTRAFILTER U-9000
  • Model / Serial
    Model Catalog: U9000 (Lot serial: 6-1907-H-01 and Higher); Model Catalog: U9000 (Lot serial: >10 numbers contact mfg)
  • Product Description
    ULTRAFILTER U 9000
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION