Disetronic D-TRONplus Power Packs recalled

July 24, 2006

Disetronic Medical Systems and the FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, which power the D-TRON Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning.

Disetronic D-TRONplus Power Packs recalled

Disetronic Medical Systems and the FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, which power the D-TRON Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shutdown occurs, insulin delivery is interrupted. An interruption in insulin delivery could lead to uncontrolled diabetes, resulting in hyperglycemia, which could trigger serious patient injury and/or death. Disetronic and its distributors will supply power packs free of charge, sent by UPS next-day shipment, to all D-TRONplus users until corrective actions have been implemented. Every user will receive a power pack together with detailed instructions. For more information, visit http://www.fda.gov/medwatch/safety/2006/safety06.htm#DTRONplus/.

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