Owen Mumford Insulin Pen Recall [UK]


UK FSA RecallUK/Basildon: Owen Mumford recalls an estimated 4,290 Insulin Pens due to dosage fault, hyperglycaemia, injury and death hazards. TSI: http://ht.ly/Gk9Hy

Direct link: http://www.tradingstandards.gov.uk/advice/advice-recall-item.cfm?id=311489

Additional information:
The UK Trading Standards Institute (“TSI”) reports the following Insulin Pens are subject to this recall:

To identify affected devices still within their packaging, look for the following packaging lot code on the outer carton.

  • 3 ml 1 Unit Autopen Classic; packaging lot code: 7VJ;AN3810
  • Autopen 24 3 ml 2 Unit; packaging lot code: 7WB; product code: AN4200
  • Autopen 24 3 ml 1 Unit; packaging lot code: 7WC; product code: AN4210
  • 3 ml 2 Unit Autopen Classic; packaging lot code: 7WD; product code: AN3800
  • Autopen 24 3 ml 2 Unit; packaging lot code: 8CN; product code: AN4200
  • Autopen 24 3 ml 2 Unit; packaging lot code: 8CP; product code: AN4200
  • Autopen 24 3 ml 1 Unit; packaging lot code: 8CR; product code: AN4210
  • 3ml 2 Unit Autopen Classic; packaging lot code: 8EL; product code: AN3800
  • 3ml 1 Unit Autopen Classic; packaging lot code: 8EM; product code: AN3810
  • Autopen 24 3 ml 1 Unit; packaging lot code: 8JK; product code: AN4210
  • 3 ml 2 Unit Autopen Classic; packaging lot code: 8JM; product code: AN3800
  • 3 ml 1 Unit Autopen Classic; packaging lot code: 8JN; product code: AN3810
  • Autopen 24 3 ml 1 Unit; packaging lot code: 8JP; product code: AN4210
  • Autopen 24 3 ml 2 Unit; packaging lot code: 8VV; product code: AN4200
  • Autopen 24 3 ml 1 Unit; packaging lot code: 8VW; product code: AN4200

To identify affected devices outside and without their packaging look for the following production lot codes that can be found on the lower part of the pen body.

  • 3 ml 1 Unit Autopen Classic; packaging lot code: 7RT; product code: AN3810
  • Autopen 24 3 ml 2 Unit; packaging lot code: 7PN; product code: AN4200
  • Autopen 24 3 ml 1 Unit; packaging lot code: 7PP; product code: AN4210
  • 3 ml 2 Unit Autopen Classic; packaging lot code: 7RV; product code: AN3800
  • 3 ml 2 Unit Autopen Classic; packaging lot code: 8KK; product code: AN3800
  • Autopen 24 3 ml 2 Unit; packaging lot code: 8XD; product code: AN4200

According to the TSI, the fault with the four specific pens Autopen Classic 1 unit Pen, Autopen Classic 2 unit Pen, Autopen 24 1 unit Pen and Autopen 24 unit 2 Pen, can cause the dose selector to suddenly revert to zero which could lead to people receiving an underdose of Insulin or no Insulin at all. The failure rate of the 4,290 recalled devices that have been distributed in the UK is 42%.

Consumers should check if they have these affected Pen and should obtain an alternative device before stopping using them. People should seek a replacement at the earliest opportunity by contacting Owen Mumford at: technical.support@owenmumford.co.uk or visiting their pharmacist.

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Additional information about this recall:
Recalls Direct RIN: 4589-2014
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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