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