Events

Recall of NeoMed Enteral Feeding Tubes with EO Connectors

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2018-RN-00734-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00734-1
  • 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
    Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
  • Action
    Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given in the Customer Letter.

Device

NeoMed Enteral Feeding Tubes with EO Connectors

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia