Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and
FDA device recall Z-1222-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Lack of assurance of sterility.
- Action taken
- The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Distribution
- Worldwide.
- Date initiated
- 2004-05-17
- Date posted
- 2004-07-20
- Date terminated
- 2006-05-10
- Location
- Indianapolis, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP (K973044) | Disetronic Medical Systems | 1997-09-15 |