Events

Recall of STERILE ARTERIO-VENOUS BLOODLINE (SINGLE PUMP)

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
    140715
  • Event Risk Class
    II
  • Event Initiated Date
    2004-07-27
  • 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
    Manufactuer has determined that the transducer protector on baxter bloodlines manufactured by infus is leaking at maximum operating condition of the hemodialysis machines.

Device

STERILE ARTERIO-VENOUS BLOODLINE (SINGLE PUMP)
  • Model / Serial
    Model Catalog: 205-053E (Lot serial: 03E266 03F306 03G398); Model Catalog: 205-053E (Lot serial: 01A037 01C080 01D196); Model Catalog: 205-053E (Lot serial: 01E227 01G343 01G330); Model Catalog: 205-053E (Lot serial: 01H353 01H377 01L476); Model Catalog: 205-053E (Lot serial: 02A009 02C166 02E282); Model Catalog: 205-053E (Lot serial: 02F334 02F340 02K485); Model Catalog: 205-053E (Lot serial: 04D278 & 04E358.); Model Catalog: 205-053E (Lot serial: 04A037 04A073 04C132); Model Catalog: 205-053E (Lot serial: 03M667 03N729 03N801); Model Catalog: 205-053E (Lot serial: 03K520 03L529 03L571); Model Catalog: 205-053E (Lot serial: 03H424 03K520 03K568); Model Catalog: 205-053E (Lot serial: 03B088 03B10103C117 03D205); Model Catalog: 205-053E (Lot serial: 02L555R 02M613 02N706); Model Catalog: 205-053E (Lot serial: 01H430 01L498 01N585)
  • Product Description
    HEMODIALYSIS BLOOD LINES
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION