Anyone with diabetes who uses insulin pens manufactured by Owen Mumford are being urged to check if their pen is a part of a large scale recall following defects discovered with the products.
The MHRA has published a press release with information which we will outline in this article for you. Anyone who may use these pens must stop using them with immediate effect and obtain a replacement as soon as possible.
About the Owen Mumford recall
The manufacturer, Owen Mumford, have launched a voluntary recall after it was found that the pens in question may not deliver the correct dosage of insulin. This can lead to hyperglycaemia if an underdose is received, which can lead to serious and lifelong consequences for diabetes sufferers.
We’re told that the dose reader may suddenly reset to zero which could lead to an underdose or no dose being received whatsoever.
The affected pens are:
- Autopen Classic 1 unit pen
- Autopen Classic 2 unit pen
- Autopen 24 1 unit pen
- Autopen 24 unit 2 pen
How many people have been affected?
The MHRA say that 4,290 pens have been distributed here in the UK and they have been said to have a failure rate of 42% – which is considerably high. This means that potentially thousands of people are at serious risk of suffering from hyperglycaemia which can result in serious consequences for anyone involved.
Anyone who has experienced any changes in their blood glucose levels should seek medical advice immediately and you can speak to your local pharmacist for a replacement product.
How do I find out if I have been affected?
The MHRA has published a list of product codes which can be identified form the packaging as follows:
Packaging lot code |
Product code |
Product name |
7VJ |
AN3810 |
3ml 1 Unit Autopen Classic |
7WB |
AN4200 |
Autopen 24 3ml 2 Unit |
7WC |
AN4210 |
Autopen 24 3ml 1 Unit |
7WD |
AN3800 |
3ml 2 Unit Autopen Classic |
8CN |
AN4200 |
Autopen 24 3ml 2 Unit |
8CP |
AN4200 |
Autopen 24 3ml 2 Unit |
8CR |
AN4210 |
Autopen 24 3ml 1 Unit |
8EL |
AN3800 |
3ml 2 Unit Autopen Classic |
8EM |
AN3810 |
3ml 1 Unit Autopen Classic |
8JK |
AN4210 |
Autopen 24 3ml 1 Unit |
8JM |
AN3800 |
3ml 2 Unit Autopen Classic |
8JN |
AN3810 |
3ml 1 Unit Autopen Classic |
8JP |
AN4210 |
Autopen 24 3ml 1 Unit |
8VV |
AN4200 |
Autopen 24 3ml 2 Unit |
8VW |
AN4200 |
Autopen 24 3ml 1 Unit |
You can identify affected devices using the production lot codes which are on the lower part of the body of the pen, as follows:
Production lot code (stamped on pen) |
Product code |
Product name |
7RT |
AN3810 |
3ml 1 Unit Autopen Classic |
7PN |
AN4200 |
Autopen 24 3ml 2 Unit |
7PP |
AN4210 |
Autopen 24 3ml 1 Unit |
7RV |
AN3800 |
3ml 2 Unit Autopen Classic |
8KK |
AN3800 |
3ml 2 Unit Autopen Classic |
8XD |
AN4200 |
Autopen 24 3ml 2 Unit |
What our Specialist Medical Negligence and Product Liability Team has to say:
We have dealt with a lot of claims of this nature where products have been defective and have caused serious injury and loss to victims. We’re concerned at the significant volume of people that may have been affected – there are thousands of these products in the UK and a failure rate of 42% is huge.
Anyone affected should contact our team on 0800 634 7575 for help and advice. All of our advice is free and on a no obligation basis.