PRA number
Published date
Product description
ARTG Number: 189785
Batch Numbers are shown on both the NovoPen Echo carton and the NovoPen Echo pen
EVG3310-6 (carton) and EVG3310 (pen)
EVG4252-2 (carton) and EVG4252 (pen)
EVG4253-2 (carton) and EVG4253 (pen)
FVG8218-4 (carton) and FVG8218 (pen)
FVG8412-3 (carton) and FVG8412 (pen)
FVG8415-1 (carton) and FVG8415 (pen)
Reasons the product is recalled
The hazards to consumers
What consumers should do
If you or someone you provide care for uses NovoPen Echo insulin cartridge holders, check the batch numbers on any devices you have to see if they are affected by this recall.
If you have a device from an affected batch and it is not currently loaded with an insulin cartridge, stop using it and replace the cartridge holder in accordance with the User Guide as soon as possible.
If the device is currently loaded with an insulin cartridge, replace the cartridge holder in accordance with the User Guide the next time you load a new insulin cartridge.
Do not stop insulin treatment without consulting with your health professional.
Be aware of signs and symptoms of hyperglycaemia. Symptoms normally come on gradually and can include:
- feeling flushed
- dry skin
- feeling sleepy or tired
- dry mouth
- 'fruity' breath
- urinating more often
- feeling thirsty
- losing your appetite
- nausea/vomiting.
You might not experience any physical signs of high blood sugar levels and only be able to detect it in your blood sugar measurements.
If you experience any signs or symptoms of hyperglycaemia while using a NovoPen Echo insulin cartridge holder, measure your blood sugar levels as instructed by your health professional and take appropriate action. Contact your health professional for further advice.
If you have a device from an affected batch, register your details (name, address, phone number, email and number of affected cartridge holders) at http://www.novonordisk.com.au/ to arrange to receive a replacement NovoPen Echo insulin cartridge holder for each of your affected devices (after approximately 7 working days).
NovoPen Echo insulin cartridge holders should always be cleaned in accordance with the instructions in the User Guide. Only a dampened cloth should be used to clean your device. Bleaching agents such as chlorine, iodine and alcohol should not be used when cleaning NovoPen Echo insulin cartridge holders. Cracking and breaking should not occur if the device is cleaned in accordance with the instructions in the User Guide.
There are no reported problems with the insulin being administered by these devices.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.
Supplier
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.