Events

Recall of FLO-GARD 6201 VOLUMETRIC INFUSION 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
    78594
  • Event Risk Class
    III
  • Event Initiated Date
    2008-10-28
  • 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
    Increase of problem code "cannot turn on" due to the retention force of cn601 being inadequate to hold front panel ribbon intact while pump is subject to bumping & jolting of normal shipment & use.

Device

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
  • Model / Serial
    Model Catalog: 2M8063R (Lot serial: ALL LOT/SN'S); Model Catalog: 2M8063L (Lot serial: ALL LOT/SN'S); Model Catalog: 2M8063 (Lot serial: ALL LOT/SN'S)
  • Product Description
    FLO-GARD INFUSION PUMP 6201
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION