Events

Recall of INFUSOR

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
    120558
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-10
  • 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 has initiated an important product information communication regarding the coiled tube infusor system. recent testing has shown that the nominal flow rate as labeled is achieved when the elastomeric reservoir is positioned 15cm-20cm (6-8 inches) below the distal luer lock and not when positioned at the same height as stated in the directions for use.

Device

INFUSOR
  • Model / Serial
    Model Catalog: 2C1071KJP (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2C1073KJP (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2C1075KJP (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2C1080KJP (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2C1082KJP (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    COILED TUBE INFUSOR
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION