viernes, 7 de julio de 2017

Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals

GovDelivery Masthead
Diabetes Monitor

Today, July 6, 2017 Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.
Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date.
The affected batches were distributed between 8/1/2016 – 6/22/2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide
For more information regarding this recall including background information and recommendations, please go to:
Steve L. Morin
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network

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