NovoPen Echo insulin cartridge holder

Official notice

11 Jul 2017

Last checked

11 Jul 2017

High riskACCC

An official ACCC notice concerns NovoPen Echo insulin cartridge holder. Using a cracked or broken insulin cartridge holder could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia (high blood sugar). Published 2017-07-11.

What to do now

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.

Recall number

68f649b4-ec6e-49e8-ad64-a5e22b02b5bf

Official notice

2017-07-11

The hazard

Using a cracked or broken insulin cartridge holder could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia (high blood sugar).

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

are

Artg Numbers

189785

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Affected products

Product 1

NovoPen Echo insulin cartridge holders are used for insulin treatment by people with diabetes. 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)

Risk / hazard

Using a cracked or broken insulin cartridge holder could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia (high blood sugar).

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

68f649b4-ec6e-49e8-ad64-a5e22b02b5bf

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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