Recall of Flocare Infinity Enteral Feeding Pump

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

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
    20500
  • Event Initiated Date
    2016-08-12
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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 flocare infinity enteral feeding pump 'air in line' (ail) alarm functionality may not always work with mixed or reconstituted powdered nutrition. un-dissolved particles may accumulate in the enteral feeding line or form a film on the inner side of the tube, around the pump sensors, which may interfere with pump air detection algorithms.
  • Action
    Manufacturer to issue advice regarding use

Device

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA