Events

Recall of GAMBRO AK-200 ULTRA

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
    106558
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-19
  • 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 has become aware that some users have not followed the start-up procedures when performing online priming with the ak200 ultra s. patients are at risk of receiving priming solution if the start-up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultra s for a patient treatment. a patient may receive priming solution if the operator/user: fails to properly attach the venous line in the venous clamp during the priming procedure and fails to verify the illumination of the machine blood path indication after patient connection and fails to confirm start of treatment.

Device

GAMBRO AK-200 ULTRA
  • Model / Serial
    Model Catalog: AK-200 ULTRA S (Lot serial: 12593); Model Catalog: AK-200 ULTRA S (Lot serial: 18143); Model Catalog: AK-200 ULTRA S (Lot serial: 18142); Model Catalog: AK-200 ULTRA S (Lot serial: 15683); Model Catalog: AK-200 ULTRA S (Lot serial: 12591); Model Catalog: AK-200 ULTRA S (Lot serial: 13299); Model Catalog: AK-200 ULTRA S (Lot serial: 19696); Model Catalog: AK-200 ULTRA S (Lot serial: 19695); Model Catalog: AK-200 ULTRA S (Lot serial: 12592); Model Catalog: AK-200 ULTRA S (Lot serial: 15681)
  • Product Description
    AK 200 ULTRA S
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION