Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and
FDA device recall Z-1197-03 · posted 2003-09-17 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
- Action taken
- An urgent product correction and removal letter dated 7/16/03 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
- Distribution
- United States
- Date initiated
- 2003-07-21
- Date posted
- 2003-09-17
- 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 |
|---|---|---|
| DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (K023471) | Disetronic Medical Systems AG | 2002-10-29 |