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
    44817
  • Event Risk Class
    II
  • Event Initiated Date
    2005-03-14
  • 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
    Manufacturer has had reports of these devices being occluded caused by inadequate lubrication applied to the slit in the upper seal of the valve boot.

Device

CONTINU-FLO IV SOLUTION SET
  • Model / Serial
    Model Catalog: 2C8546 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8864 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8537 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8519 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8374 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8378 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8399 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8606 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8612 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8632 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8634 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8571 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2H8519 (Lot serial: ALL LOT NUMBERS)
  • Product Description
    CONTINU-FLO IV SOLUTION SET
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION