| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00725-1 |
| Product Name/Description |
Flocare Gastrotomy Tubes (G-tube) ENFit connector
Flocare Gastrostomy tube (G-tube) Ch10 - ENFit
SKU: 594814
Flocare Gastrostomy tube (G-tube) Ch14 - ENFit
SKU: 594815
Flocare Gastrostomy tube (G-tube) Ch16 - ENFit
SKU: 594816
Flocare Gastrostomy tube (G-tube) Ch18 - ENFit
SKU: 594817
Flocare Gastrostomy tube (G-tube) Ch20 - ENFit
SKU: 594818
All Batches
ARTG Number: 120000 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Nutricia has received reports that the connector from the Flocare G-tube ENFit will, in in some occasions, detach. This situation generally occurs while disconnecting the ENFit G-tube from the ENFit feeding set or ENFit syringe.
If the connector is separated from the G-tube ENFit, leakage of nutrition or spillage may occur resulting in:
- an interruption or delay in therapy. When this situation remains unnoticed for a prolonged period of time, the health of a volume dependent patient can be affected due to under feeding.
- a risk of abdominal burns caused by spillage of gastric contents. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Nutrica is advising users that in order to minimise the risk of separation, they are to 1) avoid the application of excessive force or overtighten the ENfit connectors, 2) keep the ENFit connectors as clean as possible from residual nutrition and 3) flush/clean the threads of the ENFit connectors routinely to remove residual nutrition. In the event of separation, users are advised to close the quick release clamp immediately and request a suitable adaptor from Nutricia to use in place of the ENFit end. The Medicina Trainsition Adaptor will be provided and users are advised to refer to their recall letter for its proper use.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 060 051 - Nutricia Clinical Care |