Events

Recall of Flocare Transition Giving Sets (Enteral feeding tube) Flocare Infinity Pack Giving Set MLL W/O DC – TransitionFlocare Infinity Bottle Giving Set – TransitionFlocare Infinity Pack Giving Set W/O DC & W/O MP - TransitionFlocare Infinity Bottle Giving Set W/O MP – TransitionFlocare Infinity Pack Mobile Giving Set – TransitionFlocare Infinity Pack Mobile Giving Set W/O MP - Transition

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-2016-RN-00063-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00063-1
  • 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 users overseas have experienced issues with leakage and/or breakage of the enfit (white) transition adaptor included in the flocare transition giving sets (mll and mobile giving sets only). leakage could occur immediately after connection to a luer feeding tube and initiation of the feeding regime, as well as over time.The white transition adaptor may only be required by a small number of patients in australia to connect to a luer feeding tube.Higher volumes of leakage (spoilage of critical nutrition) might lead to an under infusion situation which, especially for critical and volume sensitive patients, can have a negative impact on patient health if it remains unnoticed for a longer period of time.
  • Action
    Users who are using the white transition adaptor are advised that they can continue to use the affected products. However, when using, they are advised to check giving set adaptors for any minor defects, ensuring that connectors are not over-tightened which may cause cracking, and monitoring for leakage. Furthermore, as a precautionary measure, patients/parents/carers are advised to check for any leakages after initial connection and again after approximately 2 hours. If there are signs of leakage please change the set for a new one. It is anticipated that improved adaptors will be available in the market as of April 2016. For further information, please see http://www.tga.gov.au/alert/flocare-transition-giving-sets-enfit-transition-adaptors .

Device

Flocare Transition Giving Sets (Enteral feeding tube) Flocare Infinity Pack Giving Set MLL W/O DC...
  • Model / Serial
    Flocare Transition Giving Sets (Enteral feeding tube)Flocare Infinity Pack Giving Set MLL W/O DC – TransitionFlocare Infinity Bottle Giving Set – TransitionFlocare Infinity Pack Giving Set W/O DC & W/O MP - TransitionFlocare Infinity Bottle Giving Set W/O MP – TransitionFlocare Infinity Pack Mobile Giving Set – TransitionFlocare Infinity Pack Mobile Giving Set W/O MP - TransitionCodes: 595168, 595172, 595174, 595179, 595181, 595182All batch numbers affectedARTG #: 119666
  • Manufacturer
    Nutricia Australia Pty Ltd

Manufacturer

Nutricia Australia Pty Ltd
  • Source
    DHTGA