Disetronic D-TRONplus Insulin Infusion Pump Power Packs
Class 1 Recall
|Date Recall Initiated:||July 13, 2006|
|Product:||Disetronic D-TRONplus Power Packs, Reference numbers BAT04697014001 and BAT3000813|
|Use:||The pumps are used for continuous delivery of insulin for the treatment of insulin-dependent diabetes mellitus. The power packs provide power to the D-TRONplus pumps.|
|Recalling Firm:||Disetronic Medical Systems
11800 Exit 5 Parkway, Suite 120
Fishers, IN 46038
|Reason for Recall:||The power packs have a potential to shut down the pump without warning. As a result, the pump does not have enough time to recognize the power supply decrease, and the pump may shut down before the audible and vibrating low power alarms are triggered. This can lead to an interruption of insulin delivery, which may lead to uncontrolled diabetes mellitus, resulting in elevated blood glucose levels (hyperglycemia), diabetic ketoacidosis (DKA), and death.|
|Public Contact:||Disetronic Medical Systems
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Consumers with questions may contact the company at 1-800 688-4578. This telephone number is available 24 hours a day, 365 days a year.