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U.S. Department of Health and Human Services

Safety

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D-TRON adapters, used with D-TRONplus Insulin Pump

Audience: Endocrinologists, pediatricians and other healthcare professionals

[Posted 08/01/2005] Disetronic Medical Systems and FDA notified healthcare professionals and patients about a nationwide recall of D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk. The root cause of this issue is a sporadic failure of a valve inside the D-TRON adapter to close completely, which can result in a potential over-delivery of a maximum amount of up to 1.8 I.U. of insulin.

[July 29, 2005 - News Release - FDA]