Events

Recall of Vygon Nutrisafe Syringe Feeding Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

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
    RC-2013-RN-01065-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01065-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    A calibration fault has been found when using different syringe sizes when using the orange and purple vygon nutrisafe syringe feeding pumps. the 35ml syringe is not properly recognised by the pump. additionally, only channel 2 is correctly calibrated for the orange feeding pump.
  • Action
    Device Technologies is providing users with work around instructions to follow as an interim measure. Device Technologies will contact all users to arrange for the return and correction of affected pumps taking into account operational needs. This action has been closed-out on 11/04/2016.

Device

Vygon Nutrisafe Syringe Feeding Pumps

Manufacturer

Device Technologies Australia Pty Ltd