Events

Recall of Flocare Gastrotomy Tubes (G-tube) ENFit connector

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nutricia 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-2017-RN-00725-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00725-1
  • 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
    Nutricia has received reports that the connector from the flocare g-tube enfit will, in in some occasions, detach. this situation generally occurs while disconnecting the enfit g-tube from the enfit feeding set or enfit syringe. if the connector is separated from the g-tube enfit, leakage of nutrition or spillage may occur resulting in:- an interruption or delay in therapy. when this situation remains unnoticed for a prolonged period of time, the health of a volume dependent patient can be affected due to under feeding.- a risk of abdominal burns caused by spillage of gastric contents.
  • Action
    Nutrica is advising users that in order to minimise the risk of separation, they are to 1) avoid the application of excessive force or overtighten the ENfit connectors, 2) keep the ENFit connectors as clean as possible from residual nutrition and 3) flush/clean the threads of the ENFit connectors routinely to remove residual nutrition. In the event of separation, users are advised to close the quick release clamp immediately and request a suitable adaptor from Nutricia to use in place of the ENFit end. The Medicina Trainsition Adaptor will be provided and users are advised to refer to their recall letter for its proper use.

Device

Flocare Gastrotomy Tubes (G-tube) ENFit connector
  • Model / Serial
    Flocare Gastrotomy Tubes (G-tube) ENFit connectorFlocare Gastrostomy tube (G-tube) Ch10 - ENFitSKU: 594814Flocare Gastrostomy tube (G-tube) Ch14 - ENFitSKU: 594815Flocare Gastrostomy tube (G-tube) Ch16 - ENFitSKU: 594816Flocare Gastrostomy tube (G-tube) Ch18 - ENFitSKU: 594817Flocare Gastrostomy tube (G-tube) Ch20 - ENFitSKU: 594818All BatchesARTG Number: 120000
  • Manufacturer
    Nutricia Australia Pty Ltd

Manufacturer

Nutricia Australia Pty Ltd
  • Source
    DHTGA