Consumer level recall of insulin cartridge holder

Medicines

12 Jul 2017

Six batches of the NovoPen Echo insulin cartridge holders have been recalled in Australia due to a risk they may crack or break if exposed to chemicals in certain cleaning agents.

Novo Nordisk, in consultation with the TGA, issued the recall due to the possibility a damaged device may deliver a smaller than expected dose of insulin putting people with diabetes at risk of hyperglycaemia.

The recall notice said there were no reported problems with the insulin being administered by these devices.

It also said cracking and breaking of the devices should not occur if they were only cleaned with a dampened cloth, as per instructions in the product’s User Guide.

“Bleaching agents such as chlorine, iodine and alcohol should not be used when cleaning NovoPen Echo insulin cartridge holders,” it said.

In Australia, affected batch numbers, as shown on the device, are EVG3310, EVG4252, EVG4253, FVG8218, FVG8412 and FVG8415.

Australians can register to receive replacements for affected cartridge holders at https://www.novonordisk.com/novopenecho5/en_au/form.html

There is no concern about cartridge holders with other batch numbers in Australia.

However the company recall also extends to batches in Europe, Canada, Hong Kong, Taiwan, New Zealand, South Africa and the US.

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