Global healthcare company Novo Nordisk has initiated a recall of certain insulin cartridge holders used in connection with the company’s NovoPen Echo®-brand insulin delivery devices.
According to an announcement made by the company in early July, the cartridge holders may crack or break if exposed to certain chemicals, such as cleaning agents. The defect could result in a patient receiving a reduced dose of insulin, resulting in higher than expected blood sugar levels.
Novo Nordisk says that it believes that the risk of experiencing a high blood sugar level when using a device with the recalled cartridge holder is low. However, the company has received numerous complaints of damaged cartridge holders, along with some reports of adverse events associated with the devices, thereby prompting the recall.
The recalled cartridge holders were distributed between August 2016 and June 2017.
Read the complete text of Novo Nordisk recall notice as posted to the FDA’s website.