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/.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.