Recall of GRASEBY 4000-OMNIFUSE

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
    65177
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-05
  • Event Country
  • 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) possible impact of significant vibration or jarring to omnifuse pumps: due to sensitivities of the precision accuracy detection mechanisms within omnifuse pumps certain levels of vibration or jarring during transport can induce a system fault code. 2) affect on the totaliser display after resetting the pump to clear a system fault: if a system fault code occurs during an infusion and the pump is reset the totaliser display will not include the most recent infusion data.

Device

  • Model / Serial
    Model Catalog: 0159-0710 (Lot serial: all); Model Catalog: 0158-0710 (Lot serial: all); Model Catalog: 0153-0711 (Lot serial: all); Model Catalog: 0153-0710 (Lot serial: all)
  • Product Description
    Omnifuse Syringe Pumps
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC