Deltec Cozmo Insulin Pump
FDA device recall Z-0210-05 · posted 2004-11-19 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
- Action taken
- All customers were contacted and instructed to only use the Beeper alarm function and not the vibrate alarm feature. Patients were instructed to return the affected pump to Smiths Medical MD upon receipt of the replacement pump.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 6 pumps to patients and 30 pumps in France
- Distribution
- 371 = Number of Individual Product Manufactured 6 = Number of Product Distributed to Patients 365 = Number of Products Either at Smiths Medical MD or at the Distributor or with a Smiths Medical MD Sal
- Date initiated
- 2004-09-18
- Date posted
- 2004-11-19
- Date terminated
- 2005-08-19
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (K020655) | Deltec, Inc. | 2002-08-13 |