Disetronic D-TRONplus/ACCU-CHEK D-TRON power packs
Medical device recall
| Level: | Consumer | Class: | I |
|---|---|---|---|
| Reference: | RN-2006-0524 | Date: | 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 | ||
| Phone: | 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 & II recalls are considered to be safety related recalls.