FDAnews Device Daily Bulletin

Novo Nordisk Insulin Devices May Crack When Exposed to Certain Chemicals

July 7, 2017

Novo Nordisk A/S issued a warning this week that the insulin cartridge holder used in some of its devices may be vulnerable to cracks or breaks.

Certain chemicals, including some cleaning agents, can damage the devices, according to Novo, and as a result the devices are subject to a global recall following an initial warning for certain lots distributed in Canada. Using cracked holders can lead to patients receiving insufficient doses of insulin.

Any consumers using NovoPen Echo or NovoPen 5 devices from affected lots should replace the cartridge holder, according to the company. Novo projected the risk of high blood sugar due to use of an affected device at about 1 per 1,000 patients.

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