Recall Z-1244-03 ยท LZG Pump, Infusion, Insulin
Roche Diagnostics Corp.
Disetronic Dahedi insulin infusion pump; catalog # 8500019.
| Date | Sep 23, 2003 (initiated Jul 28, 2003) |
| Status | Terminated |
| Reason | Lack of assurance of reliability. |
| Root cause | Other |
| Action | A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative. |
| Quantity | 508 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991376 | DAHEDI INSULIN INFUSION PUMP Disetronic Medical Systems, Jun 15, 1999 |