Events

Recall of ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC

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
    63785
  • Event Risk Class
    I
  • Event Initiated Date
    2016-11-30
  • 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 safety alert communication to inform customers of the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. the arterial and venous patient connectors are designed in compliance with the applicable international standards iso594 and iso8638 allowing safe connection to vascular accesses. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. to address this issue baxter is providing additional instructions on how to properly connect the devices.

Device

ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC
  • Model / Serial
    Model Catalog: 114533 (Lot serial: LOT 1634 AND ONWARDS)
  • Product Description
    Artiset Blood Tubing Set For Haemodialysis HD SN HC
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION