Sub menu

 

 

Disetronic D-TRONplus/ACCU-CHEK D-TRON power packs

Medical device recall

Potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning resulting in under-delivery of insulin.

Published
Level:Consumer
Class:I
Reference:RN-2006-0524
Date agreed:24 July 2006
Product:Disetronic D-TRONplus/ACCU-CHEK D-TRON power packs
ARTG number:99573
Batch number:All lots
Sponsor:Roche Diagnostics Australia Pty Limited
Contact:02 9899 7999 (Dr George Koumantakis)
Reason:Potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning resulting in under-delivery of insulin.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I and II recalls are considered to be safety related recalls.

Product types