Events

Recall of Compat Nasogastric Feeding Tube 8Fr, 10Fr and 12Fr

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nestle Australia 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-00764-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00764-1
  • 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
    Some affected packs of the compat ng tubes have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
  • Action
    Nestle Health Service is asking users to quarantine affected lot numbers from use. Nestle will be replacing affected stock with a replacement product.

Device

Compat Nasogastric Feeding Tube 8Fr, 10Fr and 12Fr
  • Model / Serial
    Compat Nasogastric Feeding Tube 8Fr, 10Fr and 12FrCompat Nasogastric Feeding Tube 8Fr:Lot Numbers: 08211Z and 14212UCompat Nasogastric Feeding Tube 10FrLot Number: 08712DCompat Nasogastric Feeding Tube 12FrLot Number: 05912FARTG Number: 153072
  • Manufacturer
    Nestle Australia Ltd

Manufacturer

Nestle Australia Ltd