Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
FDA device recall Z-1413-06 · posted 2006-09-12 · Terminated
Recall details
- Recalling firm
- Disetronic Medical Systems, Inc.
- Reason for recall
- The battery may turn the pump off without warning due to a design change in the battery.
- Action taken
- Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 6,604 packs to U.S. and Canada.
- Distribution
- Nationwide and Canada.
- Date initiated
- 2006-07-13
- Date posted
- 2006-09-12
- Date terminated
- 2007-11-05
- Location
- Fishers, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO D-TRONPLUS (K043000) | Disetronic Medical Systems AG | 2004-12-01 |