A recall has been issued for six batches of NovoPen Echo Insulin Cartridge Holders after the TGA detected a risk that they may crack or break if exposed to chemicals in certain cleaning agents.

Used for insulin treatment by people with diabetes, the NovoPen Echo insulin cartridge holders that are cracked or broken could result in the device delivering a smaller dose of insulin than expected, leading to serious health consequences including hyperglycaemia (high blood sugar).

Please note that there are no reported problems with the insulin being administered by these devices and that cracking and breaking should not occur if the device is cleaned in accordance with the instructions in the User Guide. The risk of patients experiencing problems as a result of this issue is considered extremely low.

The affected batch numbers are:

Batch # as shown on NovoPen Echo carton Batch # as shown on NovoPen Echo pen
EVG3310-6 EVG3310
EVG4252-2 EVG4252
EVG4253-2 EVG4253
FVG8218-4 FVG8218
FVG8412-3 FVG8412
FVG8415-1 FVG8415

People with NovoPen Echo insulin cartridge holders from an affected batch are invited to contact Novo Nordisk to arrange to receive a replacement device.

Where to locate the serial number:

novo nordisk recall serial number

Information for Consumers

Please 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.

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’re affected:

If you have a device from an affected batch, register your details at Novo Nordisk Australia(link is external) or Important safety information regarding NovoPen® Echo® and NovoPen® 5(link is external) to receive a replacement holder for those affected.

Please note that 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.

Still got concerns?

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.

 

If you have any questions or concerns about this issue, contact NovoNordisk on 1800 668 626.

 

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