Events

Recall of MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

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
    67043
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-30
  • 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
    Smiths medical became aware that the thread lock material used on a fastening screw can be ineffective. as a result the medfusion pump syringe barrel clamp mechanism may loosen and decrease the pump's ability to accurately detect the outside diameter measurement of the syringe barrel causing an "invalid syringe size" alarm to occur.

Device

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
  • Model / Serial
    Model Catalog: 4000-0105-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 4000-0101-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 3500-500 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    Pump Medfusion 4000;Pump Medfusion Model 3500
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC