Events

Recall of CONTINU-FLO IV SOLUTION SET

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
    93015
  • Event Risk Class
    II
  • Event Initiated Date
    2008-06-03
  • 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
    1)reduction in delivery accuracy may occur at programmed flow rates above 400ml/hr. 2)under worst case a flow deviaiton beyond labeled acceptable flow rate deviation may noccur which could lead to under infusion of medication.

Device

CONTINU-FLO IV SOLUTION SET
  • Model / Serial
    Model Catalog: JC6395 (Lot serial: ALL LOTS); Model Catalog: JC5548N (Lot serial: ALL LOTS); Model Catalog: 2C6571 (Lot serial: ALL LOTS); Model Catalog: JC5381N (Lot serial: ALL LOTS); Model Catalog: 2C6572 (Lot serial: ALL LOTS); Model Catalog: 2C5587 (Lot serial: ALL LOTS); Model Catalog: JC7555 (Lot serial: ALL LOTS); Model Catalog: 2C7558 (Lot serial: ALL LOTS); Model Catalog: JC7564 (Lot serial: ALL LOTS); Model Catalog: JC7562 (Lot serial: ALL LOTS); Model Catalog: JC7560 (Lot serial: ALL LOTS); Model Catalog: JC7534 (Lot serial: ALL LOTS); Model Catalog: JC7527 (Lot serial: ALL LOTS); Model Catalog: 2C8858 (Lot serial: ALL LOTS); Model Catalog: 2C8857 (Lot serial: ALL LOTS); Model Catalog: 2C8571 (Lot serial: ALL LOTS); Model Catalog: 2H8864 (Lot serial: ALL LOTS); Model Catalog: 2C8860 (Lot serial: ALL LOTS); Model Catalog: 2C8864 (Lot serial: ALL LOTS); Model Catalog: 2H8860 (Lot serial: ALL LOTS); Model Catalog: 2C7564 (Lot serial: ALL LOTS); Model Catalog: 2C7560 (Lot serial: ALL LOTS); Model Cat
  • Product Description
    CONTINU-FLO SOLUTION SET
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION