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Urgent Medical Device Correction: OneTouch® Delica® Lancing Device

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May 27, 2011

Dear Valued Customer:

Making sure patients know how to use our products safely and effectively is a top priority. We have recently identified two specific situations that could cause an accidental needle stick when using our OneTouch® Delica® Lancing Device.

  1. The key to preventing an accidental needle stick when discarding a used lancet is to cover the needle. The OneTouch® Delica® lancing device features hands-free lancet ejection. To use this feature, the user is asked to place the lancet cover on a hard surface. Then, with the used lancet still in the device, push the lancet needle into the cupped side of the cover. The cover will snap firmly in place and the lancet can then be safely ejected.

    Failure to re-cover the exposed needle in this way may prevent the lancet from ejecting. If this happens, using your fingers to remove the uncovered lancet may cause an accidental needle stick.

  2. When inserting a new lancet, it is very important not to over-tighten the cap. Tightening the cap too much can cause it to move out of alignment and may keep the lancet from going back inside the device after lancing. If this happens, the needle may stick out beyond the cap and cause an accidental needle stick.

Both of these situations can be prevented by following the instructions described in the OneTouch® Delica® Instructions for Use and as shown in this new Quick Start Guide.

To reach patients directly with this information, this Quick Start Guide will be included with the instructions for all OneTouch® Delica® Devices and Lancet Packages.

In addition, we are asking healthcare professionals and pharmacies to share this information with their patients who use the OneTouch® Delica® Lancing Device.

If you have any questions about this notification, please contact us as listed below:

People with diabetes
Telephone: 1 800-574-6138

Health Care Professionals
Telephone: 1 866-698-2992

Pharmacies
Telephone: 1 800-323-6337

Distributors/Direct Accounts
Telephone: 1 800-600-7226

 

Thank you for your support.

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