Disetronic Dahedi insulin infusion pump; catalog # 8500019.
FDA device recall Z-1244-03 · posted 2003-09-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Lack of assurance of reliability.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 508
- Distribution
- United States.
- Date initiated
- 2003-07-28
- Date posted
- 2003-09-23
- Date terminated
- 2007-01-12
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAHEDI INSULIN INFUSION PUMP (K991376) | Disetronic Medical Systems | 1999-06-15 |