| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00063-1 |
| Product Name/Description |
Flocare Transition Giving Sets (Enteral feeding tube)
Flocare Infinity Pack Giving Set MLL W/O DC – Transition
Flocare Infinity Bottle Giving Set – Transition
Flocare Infinity Pack Giving Set W/O DC & W/O MP - Transition
Flocare Infinity Bottle Giving Set W/O MP – Transition
Flocare Infinity Pack Mobile Giving Set – Transition
Flocare Infinity Pack Mobile Giving Set W/O MP - Transition
Codes: 595168, 595172, 595174, 595179, 595181, 595182
All batch numbers affected
ARTG #: 119666 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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 . |
| Contact Information |
1800 060 051 - Nutricia Clinical Care Line |