Retiro De Equipo (Recall) de NovoPen Echo

Recall

RC-2017-RN-00832-1

Class II

2017-07-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00832-1

Novo nordisk a/s has detected that the insulin cartridge holder used in a small number of novopen echo batches may crack or break after exposure to certain chemicals, in particular, certain cleaning agents. using a novopen echo insulin cartridge holder that is cracked or broken 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).There are no reported problems with the insulin being administered by these devices and that cracking and breaking should not occur if the device is cleaned in accordance with the instructions in the user guide. the risk of patients experiencing problems as a result of this issue is considered extremely low.

Patients: Where affected pens have been issued to a patient, Novo Nordisk urges patients to replace the cartridge holder, as some could be damaged (as per User Guide). Register your contact details (name, address, phone number, email and number of affected cartridge holders) either at www.novonordisk.com.au or www.novonordisk.com/novopenecho5.html in order to receive a replacement cartridge holder for your NovoPen Echo (after 7 working days, approximately). Health Care professionals: Please immediately quarantine all affected batches within your possession to prevent further distribution. Complete and return the Acknowledgment form even if no affected stock is held. Whenever the opportunity presents, please reiterate to patients that the cleaning instructions of the NovoPen Echo User Guide (page 26) describe that a cloth dampened ONLY with water (and certainly not with bleaching agents such as chlorine, iodine or alcohol) is to be used to clean the insulin pen.