Disetronic D-TRONplus Insulin Pump
FDA device recall Z-1198-03 · posted 2003-09-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
- Action taken
- An urgent product correction and removal letter dated 7/24/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 8000
- Distribution
- United States
- Date initiated
- 2003-07-24
- Date posted
- 2003-09-23
- Date terminated
- 2009-03-10
- 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 |
|---|---|---|
| MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP (K022831) | Disetronic Medical Systems AG | 2002-09-11 |