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Safety Information

Trans-Tasman Early Warning System — Alert Communication

Consumer Level Recall – NovoPen® Echo®

11 July 2017

Description
What action is Medsafe taking?
How to report adverse events

Products Affected

The product is: NovoPen® Echo®
Batch numbers: EVG3310-6
EVG4252-2
FVG8412-3
FVG8415-1

Description

Novo Nordisk A/S has detected that the insulin cartridge holder used in a small number of NovoPen® Echo® batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. NovoPen® Echo® is used for insulin treatment by people with diabetes. It is important to clean pens only as described in the User Guide.

Novo Nordisk urges people with diabetes using a NovoPen® Echo® pen from one of the affected batches to replace the cartridge holder, as some could be damaged. Please check your device batch number against the list of affected batches by following the instructions below.

A picture of the cartridge holder is shown below (figure 1)

NovoPen Echo cartridge

How to check if I have a NovoPen® Echo® from one of the four affected batches listed in the table above?

  1. Batch numbers are printed on NovoPen® Echo® as indicated below (Figure 2).
  2. Remove the cartridge holder from your pen and turn the dial on the pen so that the batch number becomes visible.
    NovoPen Echo batch number
    Figure 2. Red square shows where the batch number is located on NovoPen® Echo® E.g. the batch number on the NovoPen® Echo® shown in the image is FVG7364 (this is an example only and this batch has not been distributed in New Zealand).
  3. Write down the batch number printed on your NovoPen® Echo® and check to see if it is in the list of affected batches.

If your NovoPen® Echo® has not yet been removed from the original carton it came in, please check the batch number printed on the carton (figure 3).

NovoPen Echo carton
Figure 3. Red squares shows where the batch number is located on the NovoPen® Echo® carton.

What to do if the batch number on my NovoPen® Echo® is different to one of the four affected batches in the table above?

Importantly, if you are in possession of NovoPen Echo® with batch numbers NOT mentioned above, or NovoPen® 3 or NovoPen® 4 products, there is NO concern and you can be confident that the products will work as intended. It is important to clean pens only as described in the NovoPen® Echo® User Guide.

What to do if you have a NovoPen Echo® from one of the four affected batches in the table above?

What action is Medsafe taking?

Monitoring the consumer level recall of NovoPen® Echo®, and monitoring any adverse events that may be reported.

How to report adverse events

Email devices@moh.govt.nz
Online http://www.medsafe.govt.nz/regulatory/devicesnew/9AdverseEvent.asp
Post Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415.


Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

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