Events

Recall of Flocare Gastrostomy Tubes

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Nutricia HealthCare SA.

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
    21553
  • Event Initiated Date
    2017-06-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Nutricia Limited, 124 Favona Road, Favona, Auckland 2024
  • Reason
    The manufacturer has received reports that the connector from the flocare g-tube enfit in some occasions detaches. this situation generally occurs while disconnecting the enfit g-tube from the enfit feeding set or enfit syringe.
  • Action
    Manufacturer to issue advice regarding use

Device

Flocare Gastrostomy Tubes
  • Model / Serial
    Model: , Affected: Flocare Gastrostomy tube (G-tube) Ch10 - ENFit, Ch14 - ENFit, ) Ch16 - ENFit, Ch18 - ENFit, Ch20 - ENFit
  • Manufacturer
    Nutricia HealthCare SA

Manufacturer

Nutricia HealthCare SA
  • Manufacturer Parent Company (2017)
    Danone
  • Source
    NZMMDSA