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Disetronic Issues Product Correction Notice

In mid July 2003, Disetronic USA sent "Product Correction and Removal" letters to H-TRON, H-TRONplus, D-TRON, and D-TRONplus users. These letters describe the recent FDA Letter to Roche in which the FDA identified issues with the manufacturing processes at Disetronic's production facility in Switzerland, and informed current pump users that they have the option of discontinuing to use their pump. The FDA action affects only Disetronic users in the United States.

Disetronic is allowed to provide ongoing support and supplies for current US pump users. This includes, if necessary, providing new H-TRONplus and D-TRONplus pumps to existing customers (e.g., if their pump breaks and needs to be replaced). Therefore current Disetronic pump users in the US who are satisfied with their pump can continue to use the pump and be assured of the full support of Disetronic.

Disetronic will assist current US customers who are interested in seeking an alternative pump. Note that any full or partial refund will go to the insurance company that paid for the pump, not necessarily the customer.

Questions can be addressed to the company at 1-800-281-1986, Monday through Friday, 7:00 am to 7:00 pm Central time.

See Also

• H-TRON and H-TRONplus Letter Frequently Asked Questions
• D-TRON and D-TRONplus Letter Frequently Asked Questions
• Page 1 of H-TRON letter
• Page 2 of H-TRON letter

July 31, 2003

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			Jump to a new section --[ Getting Around ]-- Home Page What's New Privacy Policy Search --[ People ]-- Family Support Network Adults with Diabetes Care Photos Chat Rooms Conferences Kids with Diabetes Parents Parent Humor Scholarships and Financial Aid Grandparents Humorous Tidbits Jobs Mailing Lists CWD Forums Poetry and Art Videos Polls Quilt for Life Surveys Blogs --[ Clinic ]-- Ask the Diabetes Team Alternate Site Testing Alternative Treatments Care Suggestions CWD Español Diabetes Basics Diabetes at School 504 Plans Diabetes Camps Diabetes Dictionary Insulin Pumps Nutrition Podcasts Presentations Products Product Marketplace Sports Studies Warning Signs --[ Sources ]-- News and Information Diabetes Advocacy Links to Other Web Sites Press Releases Regional Information Services Support Groups --[ Feedback ]-- About CWD Advertise Awards Contribute Your Experiences Disclaimer Letters to the Editor Logos and Linking Share our Brochures

Last Updated: Thursday July 31, 2003 16:22:52
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