PRA number
2016/15159
Published date
Product description
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
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
Reasons the product is recalled
There have been reports of ENFit transition adaptors, which are supplied in Australia as a component of Flocare transition giving sets, leaking and/or breaking.
The hazards to consumers
If a transition adaptor is used and it leaks or breaks, it could lead to patients receiving less feed than intended. For some patients, especially critical and/or volume sensitive patients, this can have a negative impact on their health if it not noticed for a significant period of time. Leakage can occur immediately after connection or over time.
What consumers should do
If you or someone you care for uses Flocare transition giving sets for tube feeding, you can continue to use them. These products are not being removed from the market.
Please note that this issue only affects you if you use MLL and mobile giving sets that have a white transition adaptor on the patient-end which connects to a luer feeding tube. It does not apply to situations in which the transition adaptor is unscrewed and discarded during connection.
However, if this issue does affect you, you are advised to carefully check transition adaptors for any minor defects, avoid over-tightening connectors, and monitor for leakage after initial connection and again about two hours after connection. If any problems are identified or suspected, replace the transition giving set with a new one.
If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can contact Nutricia Australia on 1800 060 051.
Please note that this issue only affects you if you use MLL and mobile giving sets that have a white transition adaptor on the patient-end which connects to a luer feeding tube. It does not apply to situations in which the transition adaptor is unscrewed and discarded during connection.
However, if this issue does affect you, you are advised to carefully check transition adaptors for any minor defects, avoid over-tightening connectors, and monitor for leakage after initial connection and again about two hours after connection. If any problems are identified or suspected, replace the transition giving set with a new one.
If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can contact Nutricia Australia on 1800 060 051.
Supplier
Nutricia Australia Pty Ltd
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.